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1
Lombardi, Niccolò, Luca Baldini, Dimitri Rabbiosi, and Giovanni Lodi. "GVHD orale post-trapianto allogenico per mieloma multiplo." Dental Cadmos 89, no. 07 (September 2021): 501. http://dx.doi.org/10.19256/d.cadmos.07.2021.04.
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Locasciulli, A., A. Alberti, G. Bandini, P. Polchi, W. Arcese, P. Alessandrino, A. Bosi, M. Testa, and A. Bacigalupo. "Allogeneic bone marrow transplantation from HBsAg+ donors: a multicenter study from the Gruppo Italiano Trapianto di Midollo Osseo (GITMO)." Blood 86, no. 8 (October 15, 1995): 3236–40. http://dx.doi.org/10.1182/blood.v86.8.3236.3236.
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Abstract Hepatitis B virus (HBV)-infected individuals are occasionally used as donors for bone marrow transplantation (BMT). We studied the rate of HBV infection and the clinical expression of the associated liver disease in patients receiving marrow from HBsAg+ donors. We performed a retrospective survey in 14 BMT units in Italy in which all BMTs performed between 1984 and 1994 were reviewed and those involving HBsAg+ donors were identified. Donors and recipients were analyzed for HBV markers and liver disease. A total of 24 of 2,586 patients (0.9%) had received an HBsAg+ marrow. HBsAg became detectable in 22% of pre-BMT HBsAg-patients, but only 5.5% became chronic HBsAg carriers. Antigenemia developed more frequently in anti-HBs-compared with anti-HBs+ patients independently of passive prophylaxis with hyperimmune anti-HBs Ig, although the difference was not significant. Severe liver failure with death occurred in 21% of patients, which was a value greater than that generally observed after BMT in our units (3.7%). Patients with an anti-HBe+ donor had higher frequency of liver failure (28% v 0%) and alanine aminotransferase peaks as compared with those of patients with an HBeAg+ donor. Liver failure was not observed in anti-HBs+ recipients. The use of HBsAg+ donors, particularly if anti-HBe+, increases the risk of severe liver disease in BMT recipients. Anti-HBs positivity may prevent severe liver damage.
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Locasciulli, A., A. Alberti, G. Bandini, P. Polchi, W. Arcese, P. Alessandrino, A. Bosi, M. Testa, and A. Bacigalupo. "Allogeneic bone marrow transplantation from HBsAg+ donors: a multicenter study from the Gruppo Italiano Trapianto di Midollo Osseo (GITMO)." Blood 86, no. 8 (October 15, 1995): 3236–40. http://dx.doi.org/10.1182/blood.v86.8.3236.bloodjournal8683236.
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Hepatitis B virus (HBV)-infected individuals are occasionally used as donors for bone marrow transplantation (BMT). We studied the rate of HBV infection and the clinical expression of the associated liver disease in patients receiving marrow from HBsAg+ donors. We performed a retrospective survey in 14 BMT units in Italy in which all BMTs performed between 1984 and 1994 were reviewed and those involving HBsAg+ donors were identified. Donors and recipients were analyzed for HBV markers and liver disease. A total of 24 of 2,586 patients (0.9%) had received an HBsAg+ marrow. HBsAg became detectable in 22% of pre-BMT HBsAg-patients, but only 5.5% became chronic HBsAg carriers. Antigenemia developed more frequently in anti-HBs-compared with anti-HBs+ patients independently of passive prophylaxis with hyperimmune anti-HBs Ig, although the difference was not significant. Severe liver failure with death occurred in 21% of patients, which was a value greater than that generally observed after BMT in our units (3.7%). Patients with an anti-HBe+ donor had higher frequency of liver failure (28% v 0%) and alanine aminotransferase peaks as compared with those of patients with an HBeAg+ donor. Liver failure was not observed in anti-HBs+ recipients. The use of HBsAg+ donors, particularly if anti-HBe+, increases the risk of severe liver disease in BMT recipients. Anti-HBs positivity may prevent severe liver damage.
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Patriarca, F., A. Bacigalupo, A. Sperotto, M. Isola, F. Soldano, B. Bruno, M. T. van Lint, et al. "Allogeneic hematopoietic stem cell transplantation in myelofibrosis: the 20-year experience of the Gruppo Italiano Trapianto di Midollo Osseo (GITMO)." Haematologica 93, no. 10 (October 1, 2008): 1514–22. http://dx.doi.org/10.3324/haematol.12828.
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Bosi, A., S. Bacci, R. Miniero, F. Locatelli, D. Laszlo, G. Longo, A. Busca, MT Van Lint, P. Di Bartolomeo, and A. Amici. "Second allogeneic bone marrow transplantation in acute leukemia: a multicenter study from the Gruppo Italiano Trapianto Di Midollo Osseo (GITMO)." Leukemia 11, no. 3 (March 1997): 420–24. http://dx.doi.org/10.1038/sj.leu.2400585.
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Todisco, E., F. Ciceri, C. Boschini, F. Giglio, A. Bacigalupo, F. Patriarca, I. Donnini, et al. "Factors predicting outcome after allogeneic transplant in refractory acute myeloid leukemia: a retrospective analysis of Gruppo Italiano Trapianto di Midollo Osseo (GITMO)." Bone Marrow Transplantation 52, no. 7 (January 9, 2017): 955–61. http://dx.doi.org/10.1038/bmt.2016.325.
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Patriarca, Francesca F., Alessandra A. Sperotto, Barbara B. Bruno, Andrea A. Bacigalupo, Alberto A. Bosi, and Renato R. Fanin. "Allogeneic Stem Cell Transplantation in Idiopathic Myelofibrosis: The Italian Experience." Blood 108, no. 11 (November 16, 2006): 3008. http://dx.doi.org/10.1182/blood.v108.11.3008.3008.
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Abstract Allogeneic haematopoietic stem cell transplantation (HSCT) is the only curative treatment for idiopathic myelofibrosis (IM), but it is associated with a high transplantation-related (TRM) mortality rate, especially in advanced and elderly patients. Recently, reduced-intensity conditioning (RIC) regimens were reported to be feasible in these subgroups of patients. Herein, we reported a preliminary analysis of the data of the Gruppo Italiano Trapianto Midollo Osseo (G.I.T.M.O.) Registry regarding a total of 92 patients with IM, who underwent allogeneic HSCT in 25 different Italian Transplant Centres between 1986 and 2005. One Centre performed 26 transplants, 4 Institutions performed between 6 and 10 transplants and the other 20 Centres realized five or less procedures. Ten transplants (11 %) were performed before 1995, 26 (28%) between 1996 and 2000 and 56 (61%) between 2001 and 2005. Sixty patients (65%) were male and median age was 49 years ( range 21–68). Thirty-nine patients (42%) were older than 50 and 8 older than 60 years. Forty-four (48%) received myeloablative conditioning and 48 (52%) a RIC regimen. Myeloablative conditioning was based on cyclophosphamide plus thiotepa ( 42% of the patients) or busulfan (37%) or total body irradiation at the dose of 10–12 Gy (21%). RIC transplants consisted of a combination of fludarabine and 2 Gy TBI (44%) or cyclophosphamide (4%) or busulphan (4%) or an association of thiotepa and cyclophospamide (48%). GVHD prophylaxis included cyclosporin-A and short-course methotrexate, with the association of ATG in 11 patients. Stem cells came from matched sibling donors for 70 patients (76%), missmatched sibling donors for 10 patients (11%) and from matched unrelated donors for the remaining 12 patients (13%). Forty-nine patients (53%) received BM cells and the other 53 cases (47%) PBSC. Seventy-eight out 92 (85%) achieved full engrafment. One-year TRM was 35%. Causes of TRM were as following: GVHD (33% of the patients), infections (36%), bleeding (12%), veno-occlusive disease (3%), thrombotic thrombocytopenic purpura (6%). We observed a trend of higher TRM rate in patients transplanted before 2000 in comparison with those transplanted later (48% vs 33%). However, other potential risk factors for TRM, such as patient age > 50 years, conventional conditioning and unrelated or mismatched donors did not significantly increase TRM rate. There are 43 patients (47%) alive 12 to 156 months after transplantation ( median, 35 months). We conclude that, albeit TRM rate has been lowered in transplants performed in the last 5 years, it still involves one-third of the patients and remains a matter of concern. The ongoing analysis will focus on the impact of the clinical and biological factors at transplant on the outcome of the patient population.
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Girmenia, Corrado, Anna Maria Raiola, Alfonso Piciocchi, Alessandra Algarotti, Marta Stanzani, Laura Cudillo, Clara Pecoraro, et al. "Incidence and Outcome of Invasive Fungal Diseases after Allogeneic Stem Cell Transplantation: A Prospective Study of the Gruppo Italiano Trapianto Midollo Osseo (GITMO)." Biology of Blood and Marrow Transplantation 20, no. 6 (June 2014): 872–80. http://dx.doi.org/10.1016/j.bbmt.2014.03.004.
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Alessandrino, Emilio Paolo, Matteo Giovanni Della Porta, Andrea Bacigalupo, Maria Teresa Van Lint, Michele Falda, Francesco Onida, Massimo Bernardi, et al. "WHO classification and WPSS predict posttransplantation outcome in patients with myelodysplastic syndrome: a study from the Gruppo Italiano Trapianto di Midollo Osseo (GITMO)." Blood 112, no. 3 (August 1, 2008): 895–902. http://dx.doi.org/10.1182/blood-2008-03-143735.
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Abstract We evaluated the impact of World Health Organization (WHO) classification and WHO classification–based Prognostic Scoring System (WPSS) on the outcome of patients with myelodysplastic syndrome (MDS) who underwent allogeneic stem cell transplantation (allo-SCT) between 1990 and 2006. Five-year overall survival (OS) was 80% in refractory anemias, 57% in refractory cytopenias, 51% in refractory anemia with excess blasts 1 (RAEB-1), 28% in RAEB-2, and 25% in acute leukemia from MDS (P = .001). Five-year probability of relapse was 9%, 22%, 24%, 56%, and 53%, respectively (P < .001). Five-year transplant-related mortality (TRM) was 14%, 39%, 38%, 34%, and 44%, respectively (P = .24). In multivariate analysis, WHO classification showed a significant effect on OS (P = .017) and probability of relapse (P = .01); transfusion dependency was associated with a reduced OS (P = .01) and increased TRM (P = .037), whereas WPSS showed a prognostic significance on both OS (P = .001) and probability of relapse (P < .001). In patients without excess blasts, multilineage dysplasia and transfusion dependency affected OS (P = .001 and P = .009, respectively), and were associated with an increased TRM (P = .013 and P = .031, respectively). In these patients, WPSS identified 2 groups with different OS and TRM. These data suggest that WHO classification and WPSS have a relevant prognostic value in posttransplantation outcome of MDS patients.
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Girmenia, Corrado, Giovanni Barosi, Alfonso Piciocchi, William Arcese, Franco Aversa, Andrea Bacigalupo, Giuseppe Bandini, et al. "Primary Prophylaxis of Invasive Fungal Diseases in Allogeneic Stem Cell Transplantation: Revised Recommendations from a Consensus Process by Gruppo Italiano Trapianto Midollo Osseo (GITMO)." Biology of Blood and Marrow Transplantation 20, no. 8 (August 2014): 1080–88. http://dx.doi.org/10.1016/j.bbmt.2014.02.018.
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Falda, Michele, Alessandro Busca, Ileana Baldi, Nicola Mordini, Benedetto Bruno, Bernardino Allione, Alessandro Rambaldi, et al. "Nonmyeloablative allogeneic stem cell transplantation in elderly patients with hematological malignancies: Results from the GITMO (Gruppo Italiano Trapianto Midollo Osseo) multicenter prospective clinical trial." American Journal of Hematology 82, no. 10 (October 2007): 863–66. http://dx.doi.org/10.1002/ajh.20990.
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Girmenia, Corrado, Giovanni Barosi, Franco Aversa, Andrea Bacigalupo, Tiziano Barbui, Donatella Baronciani, Alberto Bosi, et al. "Prophylaxis and Treatment of Invasive Fungal Diseases in Allogeneic Stem Cell Transplantation: Results of a Consensus Process by Gruppo Italiano Trapianto di Midollo Osseo (GITMO)." Clinical Infectious Diseases 49, no. 8 (October 15, 2009): 1226–36. http://dx.doi.org/10.1086/605665.
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Todisco, Elisabetta, Fabio Ciceri, Boschini Cristina, Fabio Giglio, Andrea Bacigalupo, Francesca Patriarca, Francesca Bonifazi, et al. "Factors Predicting Outcome after Allogeneic Stem Cell Transplantation in Primary Refractory Acute Myeloid Leukemia: A Retrospective Analysis of the Gruppo Italiano Trapianto Di Midollo Osseo (GITMO)." Blood 124, no. 21 (December 6, 2014): 731. http://dx.doi.org/10.1182/blood.v124.21.731.731.
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Abstract Background The outcome of primary refractory (PRF) acute myeloid leukemia (AML) patients is poor with a minor proportion rescued by allogeneic hematopoietic stem cell transplantation (HSCT). The identification of pre-HSCT variables may help to identify PRF AML most likely to benefit from HSCT. The EBMT group reported factors predicting the outcome of 168 patients with PRF AML receiving an unrelated donor stem cell transplantation; 5-years OS was 22% and factors associated to an improved survival were the numbers of chemotherapy cycles (< 3), bone marrow blast infiltration <38% and patient CMVseropositivity. These clinical findings allowed to define 4 prognostic groups with survival rates ranging between 44% and 0% {Craddock, 2011). We performed a similar analysis focusing on PRF AML patients transplanted in Italy between 1999-2012 with a stem cell graft obtained by a sibling, unrelated donor and cord blood unit. Patients and study design We analyzed the clinical outcome of 242 patients transplanted in 26 GITMO centers. Patients disease status at HCST included PRF AML defined as failure to achieve a complete response (CR) after one or more chemotherapy cycles containing active drugs on AML. The cytogenetic and molecular risk was defined according to the European LeukemiaNet. The main clinical and outcome follow up data were retrieved from the GITMO database. The main end-points of the study were overall survival (OS) and leukemia-free survival (LFS). Results The median age at HSCT was 49 years (18-72) and 55% of patients were male. Before HSCT, 58% received ≤ 2 chemotherapy cycles. Median time from diagnosis to HSCT was 6 months (1-19) and in 85% was ≥ 3 months. An intermediate-II/adverse karyotype was detected in 58% of patients, > 25% marrow blast infiltration or any level of peripheral blood (PB) blasts was found in 60% and a pre-HSCT Karnofsky score < 90 was present in 43%. Donors were HLA identical sibling in 48% and matched unrelated in 19%, related mismatched in 19%, unrelated mismatched in 3% and cord blood in 11%. Anti-CMV antibodies were present in 87% of patients and in 65% of the donors. Conditioning regimen intensity was myeloablative or reduced in 69% and 31%, respectively; 49% of patients received T cell depletion (92% in vivo and 8% ex vivo). Neutrophils and platelets engraftment was achieved in 87% of patients after a median of 17 (9-52) and 17 (3-150) days, respectively. In all, 35 (14%) patients died within 30 days from HSCT. Of 207 patients evaluable for response, 138 (66%) achieved CR after a median time of 32 days (range 16-130) from HSCT and 69 did not (33%). Median survival of patient who achieved CR was 10 months while it was 2 months for those who did not. Seventy patients (51%) relapsed after a median time of 3 months (1-31), 64 died of disease, 6 survived and 2 of these latter reachieved CR. Sixty-eight patients (49%) maintained CR, 34(50%) died and 34 survived. A t the last follow up 42 patients were alive, 36 in CR and 6 with disease with a median follow up of 27 months (range 1,8-14). The median OS of the whole patient cohort was 5,7 months. At 3-years, the OS and LFS was 15% and 23% respectively. AGvHD was registered in 39% of patients (grade > 2 in 30% of cases) while cGVHD occurred in 29% (extended in 44% of cases). The 3-years cumulative incidence of NRM was 17%. By univariate analysis, the number of chemotherapy cycles to achieve CR (≤ 2), the time to HSCT (< 3 months), the cytogenetics risk favorable/intermediate I, the number of marrow blasts < 25% or the absence of blasts in the peripheral blood, the PS ≥ 90 and the lack of any form of T cell depletion, were all associated to a better survival. By multivariate analysis, the number of chemotherapy cycles, (Hazard Ratio (HR): 1.51; 95% confidence interval (CI): 1.04–2.19; P=0.029), the lack of T cell depletion (HR: 1.66; 95% CI: 1.15–2.40; P=0.007), the degree of BM or PB blast infiltration (HR: 1.59; 95% CI: 1.01–2.25; P=0.043), and the PS (HR: 1.46; 95% CI: 1.00–2.14; P=0.048) remained significantly associated with survival. On the basis of this multivariate analysis, we set up a new score predicting a different 3 years OS: score 0 (0 or 1 adverse prognostic factor, with 28% survival), score 1 (2 adverse prognostic factor, 17% survival); score 2 (2 or 3 adverse prognostic factors, 10% survival) (Figure 1) Conclusion The clinical outcome of PRF AML remains poor. The new simple clinical GITMO score helps indentifying patients most likely will benefit or not from the HSCT. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare.
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Alessandrino, Paolo E., Matteo G. Della Porta, Andrea Bacigalupo, Maria Teresa Van Lint, Michele Falda, Francesco Onida, Massimo Bernardi, et al. "WHO Classification and WPSS Score Predict Post-Transplant Outcome in Adults with Myelodysplastic Syndrome: A Retrospective Study by GITMO - Gruppo Italiano Trapianto Midollo Osseo." Blood 110, no. 11 (November 16, 2007): 1466. http://dx.doi.org/10.1182/blood.v110.11.1466.1466.
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Abstract WHO classification and WPSS score (JCO2007;25:3503) have been recently proved to have prognostic significance in myelodysplastic syndromes (MDS), but their impact on the outcome of patients (pts) receiving allogeneic stem-cell transplantation (allo-SCT) is still to be clarified. We retrospectively evaluated the prognostic value of WHO classification and WPSS at the time of transplant in 406 MDS pts who underwent allo-SCT between 1990 and 2006. Patients were reclassified according to the WHO criteria: 30 had refractory anemia (RA/RARS), 54 refractory cytopenia (RCMD/RS), 51 RA with excess blasts (RAEB), type 1 and 95 RAEB type 2. One hundred twenty-seven pts were classified as acute myeloid leukemia (AML). The median recipient age was 48 years (range 17–67). There were 281 HLA-matched sibling and 125 unrelated donor SCT. One hundred forty-three pts (35%) received a reduced intensity regimen (RIC). Considering WHO categories, the probability of OS at 5-years was 0.8 in RA/RARS, 0.52 in RCMD/RS, 0.48 in RAEB-1, 0.26 in RAEB-2 and 0.29 in AML, while the probability of RFS at 5-years was 0.92, 0.78, 0.74, 0.47 and 0.44 respectively. The cumulative probability of TRM was 0.43. We performed a Cox analysis with WHO category, cytogenetics, transfusion dependency, recipient age, disease status, type of donor and type of conditioning as covariates. WHO classification had a significant effect on both OS (P=0.017), and RFS (P=0.01). Cytogenetic risk significantly affected RFS (P=0.04), while had a borderline effect on OS (P=0.09). A regular transfusion dependency before SCT was associated with a reduced OS (P=0.01) and increased TRM (P=0.037), while no significant effect on RFS was noticed. Age and stage of the disease at transplant showed a significant effect on OS (P=0.02 and P=0.04, respectively). RIC and active disease at transplant were associated to a reduced probability of RFS (P=0.02 and P=0.017 respectively). Age and use of myeloablative conditioning were significant risk factors for TRM (P=0.018 and P=0.032 respectively). The WPSS score, based on MDS-WHO category, cytogenetics and transfusion dependency at the time of SCT, was calculated for 171 pts. WPSS showed a prognostic significance on both OS and RFS in a Cox analysis with age of recipient, disease status, type of donor and type of conditioning as covariates (P=0.02 and P=0.01). Focusing the analysis on 84 MDS pts without excess blasts, multilineage dysplasia and regular transfusion-dependency significantly affected post-transplant OS (P=0.005 and P=0.009, respectively), and were associated to an increased TRM. In this clinical setting, WPSS allowed to identify 2 major groups of pts (very-low/low vs. intermediate risk) with significant different OS and TRM (P=0.013 and P=0.039). In conclusion, these data show that WHO classification and WPSS have a relevant prognostic value for the post-transplantation outcome of MDS pts and should be taken into account in transplantation decision-making, especially in subjects with less advanced disease. The independent negative effect of transfusion dependency strengthens the rationale to examine the consequences of iron overload and the potential benefit of chelation therapy in MDS transplant setting.
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Shouval, Roni, Francesca Bonifazi, Joshua Fein, Cristina Boschini, Elena Oldani, Myriam Labopin, Roberto Raimondi, et al. "Prediction of Allogeneic Stem Cell Transplantation Mortality in Patients with Acute Leukemia (AL) Using the AL- European Society for Blood and Marrow Transplantation (EBMT) Risk Score in the Gruppo Italiano Trapianto Di Midollo Osseo (GITMO) Data Set: A Study on Behalf of the AL Working Party (ALWP) of the EBMT and GITMO." Blood 128, no. 22 (December 2, 2016): 989. http://dx.doi.org/10.1182/blood.v128.22.989.989.
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Abstract * AR and AN contributed equally to the abstract Background: When considering a high risk, but potentially curative procedure, such as an allogeneic hematopoietic stem cell transplantation (HSCT), prognostic models may help decision making. We have previously developed the Acute Leukemia (AL)-EBMT score for prediction of mortality following allogeneic HSCT in AL patients (Shouval et al., JCO, 2015). The score is based on 10 variables including: disease status,Karnofsky performance status, recipient age, diagnosis, interval between diagnosis to HSCT, conditioning regimen, donor type, donor and recipient CMVserostatus combination, HSCT year, and center experience (HSCT/year). External validation of the score on an independent cohort of AL patients is of importance. Methods: This was a retrospective validation study on an independent cohort of AL patients from the Italian national transplantation network (GITMO). Inclusion criteria included adult AL patients, receiving an allogeneic HSCTbetween 2000-2014. Competing risks analysis was used to calculate the 2 years non-relapse related mortality (NRM) cumulative incidence, using the Gray test to test differences between ADT score groups. Overall survival (OS), and leukemia free survival (LFS) at 2 years were estimated using the Kaplan-Meier method; hazard ratios were computed between subgroups using Cox regression for OS and LFS and competing risk regression for NRM. Competing risk regression was used to compute NRM cumulative incidence rates, considering non-transplant mortality as the competing event. The predictive ability of the AL-EBMT score was assessed using time-dependent receiver-operator curves (AUC) analysis. Results: A total of 1,848 patients from 61 Italian transplant centers were analyzed. The median age was 45.9 (IQR 35.2-55). Indications for HSCT were Acute Myeloid Leukemia (67.8%) and Acute Lymphoblastic Leukemia (32.2%). The majority of patients were in first complete remission (60.6%), and received myeloablative conditioning (81.3%). Median follow-up was 2 years (1.9-2.1, 95% CI). The AL-EBMT score was categorized according totertiles (low, intermediate, high) on the original ALWP-EBMT cohort. Increasing score intervals corresponded with decreasing probability for 2 year OS (95% CI), ranging from 75.52% (70.69-80.68) to 36.93% (32.81-41.56), and increasing probability of 2 years NRM ranging from 10.9% (7.97-14.93) to 27.39% (23.84-31.48) (Table 1, Figure 1). The highest scoring group was associated with a hazard ratio (95% CI) of 2.89 (2.01-4.16) for 2 year NRM and 3.66 (2,85-4.72) for death at 2 years (Table 2). The categorized score discrimination (AUC) for 2 year OS, LFS, and NRM was 66.42, 66.15, and 67, respectively. Conclusion: This is the first study externally validating the AL-EBMT score. The score identified 3 distinctive risk groups and was predictive of survival related outcome. It can be used as a decision support tool when considering an allogeneic HSCT in acute leukemia patients. Table 1 Cumulative Probability of NRM and OS (95% CI) at 2 Years Table 1. Cumulative Probability of NRM and OS (95% CI) at 2 Years Table 2 Hazard Ratios for Outcomes at 2 years Table 2. Hazard Ratios for Outcomes at 2 years Figure 1. Overall Survival Stratified by the AL-EBMT Score Figure 1. Overall Survival Stratified by the AL-EBMT Score Disclosures No relevant conflicts of interest to declare.
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Todisco, E., F. Ciceri, E. Oldani, C. Boschini, C. Micò, M. T. VanLint, I. Donnini, et al. "The CIBMTR score predicts survival of AML patients undergoing allogeneic transplantation with active disease after a myeloablative or reduced intensity conditioning: a retrospective analysis of the Gruppo Italiano Trapianto Di Midollo Osseo." Leukemia 27, no. 10 (July 9, 2013): 2086–91. http://dx.doi.org/10.1038/leu.2013.208.
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Millás-Mur, Jaime. "Clinical and ethical use of induced pluripotent stem cells / Uso clinico ed etico delle cellule pluripotenti indotte." Medicina e Morale 67, no. 3 (July 30, 2018): 291–305. http://dx.doi.org/10.4081/mem.2018.540.
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Since its discovery, more than a decade ago, induced pluripotent stem cells (iPS) have had a prominent relevance in the environments of biomedical research and, at the same time, their origin has been related to the search for an ethical alternative to use of the stem cells obtained from internal mass of the human embryo. In this article we intend to give an overview of its possible applications in the advancement of biomedicine and its relationship with bioethics. From its possible application to regenerate tissues, after proceeding to their differentiation; testing of drugs for different conditions; or their use in models of diseases, among which the neurological ones stand out. Also, its application in obtaining germ cells and human embryos. The situation of the first clinical trial to regenerate a tissue from the subject’s own iPS cells, and the recent allogeneic transplantation in Japan, suggest advances in the clinical translation of these cells. On the other hand, the production of germ cells from iPS cells and the new cells called extended pluripotent stem cells (EPS), obtained by genetic reprogramming through a chemical cocktail, that give rise not only to the tissues of the embryonic layers, but also extra- embryonic, are a new path to making clonation by another route.----------Fin dalla sua scoperta, per oltre un decennio, cellule staminali pluripotenti indotte (iPS) hanno un’importanza notevole nella ricerca biomedica ambienti e, allo stesso tempo, la sua origine è legata alla ricerca di un’alternativa etica all’utilizzo le cellule staminali ottenute dalla massa interna dell’embrione umano. In questo articolo diamo una panoramica delle possibili applicazioni nell’avanzamento biomedicina e la loro relazione bioetica. Dalla sua possibile applicazione di rigenerare il tessuto, quindi procedere alla differenziazione; la sperimentazione di farmaci per diversi disturbi; o il suo uso in modelli di malattie, tra cui spiccano quelle neurologiche. Così come la sua applicazione nell’ottenere cellule germinali e embrioni umani. La situazione del primo studio clinico per rigenerare un tessuto da cellule iPS e proprio trapianto recente del soggetto in Giappone rappresentano passi nella traduzione clinica di queste cellule. Inoltre la produzione di cellule germinali dalle cellule iPS e nuove cellule chiamate cellule staminali pluripotenti estesi (EPS), riprogrammando geneticamente da un cocktail chimico, causando non solo ai tessuti degli strati embrionali, ma extraembrionali anche costituire un nuovo percorso verso la clonazione di un altro itinerario.
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Gori, E., M. Arpinati, F. Bonifazi, A. Errico, A. Mega, F. Alberani, V. Sabbi, et al. "Cryotherapy in the prevention of oral mucositis in patients receiving low-dose methotrexate following myeloablative allogeneic stem cell transplantation: a prospective randomized study of the Gruppo Italiano Trapianto di Midollo Osseo nurses group." Bone Marrow Transplantation 39, no. 6 (February 5, 2007): 347–52. http://dx.doi.org/10.1038/sj.bmt.1705590.
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Alessandrino, Emilio Paolo, Emanuele Angelucci, Mario Cazzola, Matteo Giovanni Della Porta, Paolo Di Bartolomeo, Antonella Gozzini, Luca Malcovati, Pietro Pioltelli, Simona Sica, and Alberto Bosi. "Iron overload and iron chelation therapy in patients with myelodysplastic syndrome treated by allogeneic stem-cell transplantation: Report from the working conference on iron chelation of the Gruppo Italiano Trapianto di Midollo Osseo." American Journal of Hematology 86, no. 10 (August 2, 2011): 897–902. http://dx.doi.org/10.1002/ajh.22104.
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Olivieri, Attilio, Michele Cimminiello, Franco Locatelli, Marco Zecca, Paolo Corradini, Francesca Patriarca, Nicola Mordini, et al. "Imatinib Is Safe and Effective In Patients with Refractory Chronic Graft Versus Host Disease: Analysis of Two Consecutive Prospective GITMO* Studies.*Gruppo Italiano Trapianto Midollo Osseo." Blood 116, no. 21 (November 19, 2010): 246. http://dx.doi.org/10.1182/blood.v116.21.246.246.
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Abstract Abstract 246 Introduction. Chronic graft versus host disease (cGvHD) remains a serious and potentially lethal complication following allogeneic hemopoietic stem cell transplants (HSCT). Imatinib may be a treatment option, because of its inhibitory activity on platelet derived growth factor (PDGF)(Svegliati Blood 2007; 110:237). Last year we reported a first feasibility study in 19 patients, receiving Imatinib as compassionate use for refractory cGVHD, with encouraging results (Blood 2009;114:709). We have treated an additional 25 patients (with Imatinib supplied by Agenzia Italiana del Farmaco-AIFA) using similar inclusion/exclusion criteria, and are now reporting response rates on 44 patients, with a median follow up of 31 months. Patients and methods. Overall 44 patients with cGVHD, refractory to two or more lines of therapy, including steroids, have been consecutively enrolled: 29 were male and 15 female, with median age 38 years (range 10–67). Median duration of cGVHD was 35 (range 6–148) months and all patients received ≥2 lines of therapy, (22 previously treated with ECP and/or Rituximab). The main cGVH targets were represented by lung in 19 patients (Bronchiolitis Obliterans Pneumonia/fibrosis), skin in 38 (generalized scleroderma in 17 and localized in 21); 17 patients had Sicca Syndrome, 9 other visceral manifestations and one severe eosinophilic fasciitis. Imatinib administration was planned for a minimum of 6 months and all patients received the same schedule of Imatinib: in absence of severe toxicity the initial dose of 100 mg/day was increased to 200 mg/day and if no response occurred the dose was increased up to 400 mg/day. The median duration of treatment was 24 months (6-40) and 23 patients are still on Imatinib. Results: the treatment was well tolerated (41 patients were able to complete the treatment for at least 6 months) and we did not observe toxic deaths; the haematological toxicity was mild, only one patient developing a grade 3 anemia, while the main grade 3–4 extrahematological adverse events were infections (3 pneumonia and 1 John Cunningham Virus infection) or fluid retention (2 cases). The response rate (excluding minor responses), evaluated according to the NIH criteria, was 59%, both at 6 months and at 12 months after the start of treatment. In 5 patients we observed the relapse of the underlying disease, while two developed a second tumor (1 diffuse large cell lymphoma and 1 spinocellular carcinoma). With a median follow-up of 31 months (8-40) 33 patients are alive (OS=75 %) and 11 patients died: causes of death were the underlying disease (n=5), second tumour (n=2), and cGVHD (n=4) (2 due to GVHD progression and 2 due to infections). Twenty patients of the original 44 (45%) are still maintaining a response to Imatinib, without requiring additional treatment; 13/44 (29%) are recorded as responders, but, after further treatment. Purified immunoglobulins from 8 patients have now been evaluated for their ability to induce Reactive oxygen species (ROS) output in PDGF-R+ve murine fibroblasts, before and during Imatinib treatment, by using the same methodology previously published)(Svegliati Blood 2007;110:237); at baseline we confirmed the high ROS output in all evaluable patients; interestingly the IgG samples from 4 patients responding to Imatinib, showed a significantly reduced ability to increase ROS output; on the contrary 3 out of the 4 IgG samples from patients refractory to Imatinib, showed a persistence of the ability to trigger the ROS output during treatment with Imatinib. Conclusions In conclusion we can confirm safety and efficacy of Imatinib in this larger series of patients with steroid-refractory cGVHD, with promising OS. Whether this benefit is mainly due to the anti-fibrotic effect or to an immunomodulatory effect (or both) induced by Imatinib, remains to be determined. This work has been partly supported by AIFA. Disclosures: Leoni: Celgene: Honoraria.
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Rambaldi, Alessandro, Anna Grassi, Maria Caterina Micò, Alessandro Busca, Benedetto Bruno, Irene Cavattoni, Stella Santarone, et al. "Randomized Trial of Busulfan with Cyclophosphamide Versus Busulfan with Fludarabine As Preparative Regimen to Allogeneic Hematopoietic Stem Cell Transplantation in Patients with Acute Myeloid Leukemia: A Study from the Gruppo Italiano Trapianto Midollo Osseo (GITMO)." Blood 124, no. 21 (December 6, 2014): 727. http://dx.doi.org/10.1182/blood.v124.21.727.727.
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Abstract Background The combination of a myeloablative dose of intravenous (iv) busulfan with cyclophosphamide is the standard preparative regimen for allogeneic hematopoietic stem cell transplantation (HSCT) in acute myeloid leukemia (AML) patients. However, in patients older than 40 years, this conditioning can be associated to high non relapse mortality (NRM). A similar myeloablative dose of busulfan combined to fludarabine was found associated to a lower NRM in older AML (Alatrash, BBMT 2011). Patients and study design The Gruppo Italiano Trapianto Midollo Osseo (GITMO) conducted a Phase III, randomized, multicenter, trial to compare the standard myeloablative combination of iv busulfan (Busilvex®, Pierre Fabre, Boulogne, France) at a dose of 0.8 mg/kg/6h over two hours infusion for 4 consecutive days (16 doses), for a total dose of 12.8 mg/kg, in combination with cyclophosphamide at the dose of 60 mg/kg/day for 2 consecutive days for a total dose of 120 mg/kg (BUCY2 arm) or fludarabine at the dose of 40 mg/m2/day for 4 consecutive days, for a total dose of 160 mg/m2 (BUFLU arm). Eligible were patients with a diagnosis of AML in 1st or 2nd complete remission (CR) with an age ≥40 and ≤ 65 years, and the availability of an HLA compatible sibling or unrelated donor as defined by molecular high-resolution typing (4 digits) of the HLA gene loci class I (HLA- A, B, and C) and class II (DRB1). Excluded were patients with a t(15;17) or PML/RARα positive APL or with a t(8;21)(q22;q22) or an inv(16) or t(16;16)(p13;q22) positive AML in 1st CR. The GvHD prophylaxis was based on conventional Cyclosporine A and Methotrexate. In case of unrelated donors, anti Thymocyte Globulin (Thymoglobuline®, Sanofi-Aventis) was given at a total dose of 5 mg/kg (or 7.5 mg/kg, in case of HLA acceptable disparity) (one antigen/allele disparity in class I, or one allele disparity in class II). The primary study end-point was the one-year NRM using an intent-to-treat analysis. The required sample size was calculated assuming that the one-year NRM would have been halved (from 25% to 12.5%) in the BUFLU arm. The cumulative incidence of NRM was estimated by considering relapse as a competing event. All outcomes were evaluated from the date of transplantation. The study was approved by the Institutional Review Boards of each center. Results From July 2008 to February 2013, 25 centers in Italy and 1 in Israel, enrolled 245 patients who were randomly assigned to BUCY2 (n=121) or BUFLU (n=124), stratified according to donor type and remission (1st vs. 2nd or more). The main clinical features (balanced between the randomization arms) were as follows: the median age was 50 years, 209 patients (85%) were in 1st and 36 (15%) in 2ndCR and the ELN risk subgroups were good (11%), intermediate-1 (46%), intermediate-2 (20%) and adverse (23%). The donor was a sibling related (n= 112, 46%) or matched unrelated (n= 133, 54%) while the stem cell graft was the peripheral blood (PB, n= 168, 69%) or the bone marrow (BM, n= 77, 31%). The overall survival rate in the BUCY2 and BUFLU arm was 71% vs. 78% at 1 year, 65% vs. 62 % at 2 years and 56% vs. 57% at 5 years, respectively (P=ns). A non-significant lower incidence of relapse was documented in the BUCY2 vs. the BUFLU arm being 20.7% vs. 24.2% at 1 year, 25.6% vs. 29% at 2 years and 28.9 vs. 32.3 at 5 years, respectively. On the contrary, at 1 year, the overall NRM in the BUCY2 arm was 17.4% vs. 7.3% in the BUFLU (Gray Test P=0.02). At 2 years and throughout the study, the same significantly different NRM was observed between study arms being respectively 18.2% vs. 8.9% and 19% vs. 9.7% (Gray Test P=0.03) (Figure 1). Causes of NRM in the BUCY2/BUFLU arms were: infections 8/6, organ failures 9/0, GvHD 5/3, hemorrhage 1/1, others 0/2. All in all, at 1, 2 and 5 years the leukemia free survival of the BUCY2 and BUFLU arm was similar being 62% vs. 69%, 56% vs. 62% and 50% vs. 56%, respectively (P=ns) (Figure 2). The number of patients with grade III-IV acute GvHD was higher in the BUCY2 arm (P= 0.02). There were no significant between-group differences in the incidence of chronic GvHD. Conclusion In AML patients older than 40 years, the reduced toxicity conditioning with iv BUFLU significantly reduced the NRM compared to BUCY2. The increased incidence of leukemia relapse in the BUFLU arm was not associated with a detrimental effect on overall and leukemia free survival. (Funded by a grant from the Agenzia Italiana per il Farmaco (AIFA), ClinicalTrial.gov Identifier: NCT1191957). Figure 1 Figure 1. Figure 2 Figure 2. Disclosures Rambaldi: Pierre Fabre Pharma: Consultancy.
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Castagnola, Elio, Francesca Bagnasco, Stefania Menoni, Monica Muraca, Arcangelo Prete, Tamara Belotti, Anna Paola Iori, et al. "Risk factors associated with development and mortality by invasive fungal diseases in pediatric allogeneic stem cell transplantation. A pediatric subgroup analysis of data from a prospective study of the Gruppo Italiano Trapianto di Midollo Osseo (GITMO)." Bone Marrow Transplantation 53, no. 9 (March 21, 2018): 1193–97. http://dx.doi.org/10.1038/s41409-018-0160-2.
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Della Porta, Matteo Giovanni, Emilio Paolo Alessandrino, Christopher H. Jackson, Cristiana Pascutto, Andrea Bacigalupo, Luca Malcovati, Maria Teresa Van Lint, et al. "Decision Analysis of Allogeneic Stem Cell Transplantation in Patients with Myelodysplastic Syndrome Stratified According to the Revised International Prognostic Scoring System (IPSS-R)." Blood 124, no. 21 (December 6, 2014): 531. http://dx.doi.org/10.1182/blood.v124.21.531.531.
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Abstract Myelodysplastic syndromes (MDS) are heterogeneous myeloid neoplasms that range from indolent conditions to forms very close to acute leukemia (AML). The International Prognostic Scoring System (IPSS) is the benchmark for clinical decision-making. Recently, the International Working Group for Prognosis in MDS (IWG-PM) defined 5 new cytogenetic risk groups on a large cohort of patients representing the basis for the revised IPSS (IPSS-R) together with refined categories for marrow blasts and cytopenias (Blood. 2012;120:2454-65). IPSS-R categorization enables more accurate definition of the prognosis of MDS patients, in particular those in low or intermediate-1 IPSS risk groups. Despite recent progress, the only curative treatment for MDS remains allogeneic stem cell transplantation (allo-SCT), which however involves a non-negligible risk of mortality/morbidity. Allo-SCT is not considered in patients with very low IPSS-R risk, whose median survival is 9 years. Conversely, eligible patients with high or very high IPSS-R risk, whose survival is 1–2 years, should be offered immediate transplantation. Uncertainty exists about the optimal timing of allo-SCT in the low and intermediate IPSS-R risk groups, and to address this issue we performed an ad hoc decision analysis. We analyzed two cohorts of MDS patients (age 18-70 years): i) 477 patients diagnosed with MDS at the Policlinico S. Matteo, Pavia, Italy between 2000–2010, who mostly received best supportive care; ii) 488 patients who received allo-SCT in the same period reported to the Gruppo Italiano Trapianto di Midollo Osseo (GITMO) registry. We adopted a continuous time multi-state Markov approach to model the natural history of the disease. Each IPSS-R risk group is represented by a state, and transition is allowed to the next state (to AML from very high risk) or to death. A transition intensity (i.e., instantaneous risk of moving to another state) is then estimated for each possible transition. Allo-SCT is modeled as a time-dependent covariate with 3 levels: i) no allo-SCT; ii) transplantation done no more than 3 months before; iii) transplantation done more than 3 months before. The effect of allo-SCT on survival was estimated by hazard ratios (HR) with respect to the no allo-SCT level. We examined two different policies: policy A) perform allo-SCT after t months since entering the low IPSS-R risk state or immediately in case of disease progression before the planned delay time t; policy B) perform allo-SCT after t months since entering the intermediate IPSS-R risk state or immediately in case of disease progression before the planned delay time t. For each policy, the expected survival of patients with different age at diagnosis was calculated. According to the model, a patient with a low IPSS-R risk is expected to spend 2.13 years in this risk group, and 2.39 years in the intermediate one. The cumulative incidence of progression from low to a higher IPSS-R risk was 27% at 3 years, while that of progression from intermediate to a higher risk was 39% at 3 years. Overall, expected survival times from diagnosis were higher under policy B vs policy A. Expected survival times were up to three years greater under policy B with respect to policy A for younger patients. When the waiting time before transplantation was progressively increased from 0 to 60 months, there was an increase in expected survival under policy A (in younger patients this increases by about two further years if transplant is delayed until 60 months in low IPSS-R risk state). Conversely, under policy B, delaying transplant further reduces expected survival, by up to about three years with a delay of 60 months after entering intermediate risk state or further progression to high risk state. In summary, this study suggests that a delayed transplantation strategy is advisable for patients with early disease, i.e. very low and low IPSS-R risk, whereas no further delay is advised for patients belonging to intermediate or higher risk categories. When indicated, setting the timing of intervention immediately after disease progression makes such a strategy easy to implement in the clinical practice. These results provide clinicians with a base of evidence to maximize the effectiveness of allo-SCT in MDS patients. Disclosures No relevant conflicts of interest to declare.
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Vaughn, Jennifer E., Barry E. Storer, Philippe Armand, Roberto Raimondi, Christopher J. Gibson, Alessandro Rambaldi, Fabio Ciceri, et al. "Pre-Transplant Ferritin, Albumin and Platelet Count Add Prognostic Information to Comorbidities for Allogeneic Hematopoietic Cell Transplantation (HCT) Outcomes: A Multi-Center Discovery-Validation Study." Blood 124, no. 21 (December 6, 2014): 421. http://dx.doi.org/10.1182/blood.v124.21.421.421.
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Abstract Albumin, ferritin, and peripheral blood counts broadly capture health status in patients undergoing allogeneic stem cell transplantation (HCT). Whether they add any prognostic information to the HCT-Comorbidity Index (HCT-CI) is unknown. We analyzed the independent prognostic role of a group of 5 biomarkers (ferritin, albumin, absolute neutrophil count (ANC), hemoglobin (Hgb), and platelet (Plt) count) in pts given allogeneic HCT for hematologic malignancies. This was a multi-center, retrospective discovery-validation study comprising data from 3917 recipients of allogeneic HCT at the Fred Hutchinson Cancer Research Institute (FHCRC) (n=1789) and Dana Farber Cancer Institute (DF) (n=716) in the US and the Gruppo Italiano Trapianto di Midollo Osseo (GITMO) (n=1412) in Italy (Table 1). Proportional hazard models were used to estimate the hazards of non-relapse mortality (NRM) and survival after adjustment for the HCT-CI, donor type, CMV serostatus, regimen intensity, age, disease risk and Karnofsky Performance Status (KPS). These were stratified by institution. Model performances were tested by c-statistic estimates. In an initial analysis within the FHCRC population, ANC of <500 and Hgb of < 9 were not associated with outcomes in the models. Alternatively, ferritin >1000 (HR 1.98; p=0.0003) and >2500 (HR 1.97; p=0.0005); albumin <3.5 (HR 1.63; p<0.00001) and <3.0 (HR 1.73 p<0.0001); and Plt <100k (HR 1.65; p<0.0001), <50k (HR 1.52; p<0.0001) , and <20K (HR 1.54; p<0.008) were all statistically significantly associated with NRM. Results were validated in a larger population from DF and GITMO. In multivariate models, adjusted for previously mentioned variables, ferritin >2500 and incremental decreases in albumin and Plt counts had statistically significant associations with both NRM and survival (Table 2). Of note, HCT-CI scores (2, 3 and >4) also retained significant associations with NRM and survival in the presence of the three biomarker values and in both cohorts. Subsequent multivariate analyses stratified the whole cohort (n=3917) into a training (n=2352) and a validation (n=1407) set. In both sets, albumin <3.5, plts <100K, and ferritin >2500 had statistical significance associations with NRM and survival. Each of the three biomarker values were subsequently assigned a weight of 1 following the same equation used to develop the HCT-CI. The augmented HCT-CI/biomarker index had higher c-statistic estimate (0.61) for prediction of NRM compared to the HCT-CI alone (0.58) in the validation set. Ferritin, albumin, and Plt counts are simple and valid prognostic biomarkers for transplant outcomes and should be considered in combination with the HCT-CI in risk assessment prior to allogeneic HCT. The physiology behind these associations warrants further investigation to identify areas of intervention that may improve outcomes. Table 1: Pt characteristics FHCRC(N=1789) DF/GITMO(N=2128) N (%) N (%) Donor Related 900 (50) 1062 (50) Unrelated 889 (50) 1053 (50) Disease risk Low 740 (41) 866 (43) High 1049 (59) 1157 (57) Age < 50 1025 (57) 1120 (53) ≥ 50 764 (43) 1008 (47) Conditioning MA 983 (55) 1100 (52) RIC/NMA 806 (45) 1004 (48) Pt CMV - 773 (43) 505 (24) + 1016 (57) 1581 (76) KPS ≤ 90 691 (39) 644 (33) 90-100 1098 (61) 1304 (67) Table 2: Multivariate analysis showing the associations between biomarkers and NRM and survival. NRM Survival Marker HR1 P1 HR1 P1 FHCRC Albumin ≥3.5 1.0 1.0 <3.5 - 3.0 1.44 0.002 1.45 <0.0001 <3.0 1.77 <0.0001 1.77 <0.0001 Unk 1.15 0.38 1.19 0.11 Plts ≥100K 1.0 1.0 <100K – 50K 1.48 0.0007 1.28 0.003 <50K – 20K 1.49 0.003 1.37 0.001 <20K 1.64 0.005 1.58 0.0004 Unk 0.66 0.47 0.48 0.14 Ferritin ≤1000 1.0 1.0 >1000 - 2500 1.60 0.03 1.70 0.0006 >2500 2.08 0.001 1.63 0.007 Unk 1.42 0.03 1.44 0.002 HCT-CI 0 1.0 1.0 1 1.29 0.12 1.31 0.02 2 1.50 0.01 1.42 0.001 3 2.29 <0.0001 2.04 <0.0001 ≥ 4 2.94 <0.0001 2.42 <0.0001 DF/GITMO Albumin ≥3.5 1.0 1.0 <3.5 - 3.0 1.60 0.0001 1.36 0.0005 <3.0 2.77 <0.0001 2.18 <0.0001 Unk 1.61 0.01 1.11 0.49 Plts ≥100K 1.0 1.0 <100K – 50K 1.08 0.56 1.02 0.85 <50K – 20K 1.17 0.28 1.21 0.06 <20K 1.38 0.04 1.35 0.009 Unk 0.64 0.10 0.82 0.28 Ferritin ≤1000 1.0 1.0 >1000 - 2500 1.11 0.43 1.23 0.02 >2500 1.60 0.002 1.69 <0.0001 Unk 1.13 0.33 1.12 0.19 HCT-CI 0 1.0 1.0 1 1.31 0.05 1.14 0.19 2 1.29 0.10 1.25 0.04 3 1.48 0.006 1.46 0.0001 ≥ 4 1.74 <0.0001 1.66 <0.0001 1 Adjusted for donor , CMV serostatus , regimen intensity , age , disease risk , KPS ; stratified on institution. Unk=Unknown Disclosures No relevant conflicts of interest to declare.
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Alessandrino, Emilio Paolo, Matteo G. Della Porta, Luca Malcovati, Christopher H. Jackson, Cristiana Pascutto, Andrea Bacigalupo, Maria Teresa van Lint, et al. "Decision Analysis of Allogeneic Stem Cell Transplantation in Patients with Myelodysplastic Syndrome Stratified According to the Who Classification-Based Prognostic Scoring System (WPSS)." Blood 118, no. 21 (November 18, 2011): 116. http://dx.doi.org/10.1182/blood.v118.21.116.116.
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Abstract Abstract 116 Myelodysplastic syndromes (MDS) are heterogeneous myeloid neoplasms that range from indolent conditions with a near normal life expectancy to forms very close to acute myeloid leukemia (AML). The WHO classification-based Prognostic Scoring System (WPSS) is able to classify MDS patients into five risk groups (very low, low, intermediate, high, and very high) with different median survival (from more than 10 to about 1 yr). Despite recent progress, the only curative treatment for MDS remains allogeneic stem cell transplantation (allo-SCT), which however involves a non-negligible risk of mortality and morbidity. Allo-SCT is not considered in patients with low WPSS risk, whose median survival is >10 yr. Conversely, eligible patients with high or very high WPSS risk, whose median survival is 1–2 yr, should be offered immediate transplantation. Uncertainty exists about the optimal timing of allo-SCT in the low and intermediate WPSS-risk groups, and to address this issue we performed an ad hoc decision analysis. We analyzed two cohorts of MDS patients: i) 615 patients diagnosed with MDS at the Fondazione IRCCS Policlinico San Matteo, Pavia, Italy, between 1992–2007, who were followed regularly and mostly received best supportive care; ii) 405 patients who received allo-SCT between 1997–2007, reported to the Gruppo Italiano Trapianto di Midollo Osseo (GITMO) registry. In this latter cohort, variables were analyzed at the time of transplantation in patients undergoing allo-SCT upfront, and at the time of remission-induction chemotherapy in those receiving treatment before allo-SCT. We adopted a continuous time multi-state Markov approach to model the natural history of the disease. In this model, each WPSS risk group is represented by a state, and transition is allowed to the next state (to AML from very high risk) or to death. A transition intensity (i.e., instantaneous risk of moving to another state) is then estimated for each possible transition. Allo-SCT is modeled as a time-dependent covariate with 3 levels: i) no allo-SCT; ii) transplantation done no more than 3 months before; iii) transplantation done more than 3 months before. The effect of allo-SCT on survival was estimated by hazard ratios (HR) with respect to the no allo-SCT level. We examined two different policies: policy A) to perform allo-SCT after t months since entering the low-risk state or at the time of progression to intermediate risk; policy B) to perform allo-SCT after t months since entering the intermediate-risk state or at the time of progression to high risk. For each policy, the expected survival of patients with different age at diagnosis was calculated. According to the model, a patient with a low WPSS risk is expected to spend 6.2 years (95% CI, 5.5–7.0) in this risk group, and, in case of progression, 3.5 years (95% CI, 3.1–4.0) in the intermediate one. The cumulative incidence of progression from low to a higher WPSS risk was 9%, 31% and 41% at 1, 3 and 5 years, respectively, while that of progression from intermediate to a higher risk was 18%, 40% and 53% at 1, 3 and 5 years, respectively. Overall, expected survival times from diagnosis were higher under policy A vs policy B. Expected survival decreased with increasing age (from 30 to 65 yr) under policy A, while there was little effect of age under policy B. For younger patients, expected survival times were up to four years greater under policy A, while there was no estimated benefit for patients closer to age 65. When the waiting time before transplantation was progressively increased from 0 to 60 months, there was a small decrease in expected survival under policy A for younger patients. Conversely, varying the time of transplantation between 0–60 months did not substantially influence expected survival under policy B. These findings suggest that in eligible patients with low or intermediate WPSS-risk MDS there is no clear benefit in adopting a delayed transplantation strategy, as the risk of progression abolishes the expected gain in survival resulting from postponing the procedure. In particular, younger patients appear to benefit from early transplantation in the low risk state. This is at variance with a previous decision analysis based on the International Prognostic Scoring System (IPSS) (Blood. 2004;104:579–85), which concluded that for low and intermediate-1 IPSS-risk MDS, delayed allo-SCT was associated with maximal life expectancy. This paper is on behalf of GITMO investigators. Disclosures: No relevant conflicts of interest to declare.
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Corradini, Paolo, Anna Dodero, Lucia Farina, Roberto Fanin, Francesca Patriarca, Rosalba Miceli, Paola Matteucci, et al. "Long-Term Follow-up of Patients Affected by Relapsed Lymphomas Receiving Reduced-Intensity Conditioning (RIC) Regimen Followed by Allogeneic Stem Cell Transplantation (Allo-SCT): An Update of the Phase II Study of the Gruppo Italiano Trapianto Di Midollo Osseo (GITMO)." Blood 112, no. 11 (November 16, 2008): 3303. http://dx.doi.org/10.1182/blood.v112.11.3303.3303.
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Abstract Several groups have reported the results of Allo-SCT following a RIC regimen in relapsed and refractory lymphomas. However, the long-term efficacy of this strategy is still unknown. We report herein the results of a prospective multicenter phase II trial at median follow-up of 5 years. A total of 194 relapsed/refractory lymphomas received the same RIC regimen (thiotepa, cyclophosphamide and fludarabine) followed by Allo-SCT from sibling donors. Histologies were non-Hodgkin’s lymphomas (NHL) [indolent (LG-NHL, n=68), including follicular lymphoma (FL, n=29), chronic lymphocytic leukemia (CLL, n=35), other (n=4); aggressive (HG-NHL, n=87), including B-cell phenotype (n=43), T-cell phenotype (n=28), mantle cell lymphoma (MCL, n=16)] and Hodgkin’s lymphoma (HL, n=39). 133 (68%) of 194 patients (pts) had chemosensitive disease and 100 (52%) of 194 failed a previous autologous transplantation. Median follow-up was 60 months (range, 15–113). At last follow-up, 116 pts are alive (59%) and 78 died from any cause [n=47 for disease progression, n= 30 for non-relapse mortality (NRM), n=1 not assessable]. The 5-year overall survival (OS) and progression-free survival (PFS) were 62% and 70% for LG-NHL, 61% and 59% for HG-NHL, and 42% and 19% for HL, respectively. The median time to relapse was 7 (range, 2–30), 4.5 (range, 1.6–33), and 5.5 (range, 0.4–42) months for LG-NHL, HG-NHL, and HL respectively. Pts with chemosensitive disease at Allo-SCT had 5-year OS and PFS of 69% and 61%, while those with refractory disease had 5-year OS and PFS of 35% and 45%, respectively. Status of disease at Allo-SCT influenced significantly long-term outcome in HG-NHL and HL [chemosensitive versus chemorefractory: 73% versus 32% (p<0.001) for HG-NHL; 64% versus 0% (p<0.002) for HL] but not in LG-NHL [chemosensitive versus chemorefractory: 65% versus 56% (p=0.43)], probably related to a stronger graft-versus-lymphoma effect in LG-NHL. Although, the 5-year PFS was significantly different between FL and CLL (85% versus 58%, p=0.04), the 5-year OS was not (71% versus 56%, p=0.13). The OS and PFS were not significantly different between aggressive lymphoma of B- and T-cell phenotype [5 year OS: 67% versus 55% (p= 0.51); 5 year PFS: 63% versus 57% (p=0.45)], respectively. Additionally, the comparison of a subgroup of pts receiving Rituximab within 6 months prior to Allo-SCT (n=38) with an homogeneous group of pts who did not receive the antibody (n=60) did not influence the outcome. Overall, 30 pts died of transplant-related causes (n=13 infections, n=12 GVHD, n=1 VOD, n=2 MOF and n=2 second tumor) at median follow-up of 6 months (range, 0.8 to 60) with a 5-year cumulative incidence of 15%. The incidence of acute and chronic GVHD were 34% and 55%, respectively. Interestingly, only 27 of 116 (23%) pts are still receiving immune suppressive therapy. The incidence of second tumors was 2% in the pts surviving more than 6 months after Allo-SCT (n=2 alive, n=2 death). In conclusion, analysis of our series with a median 5-year follow-up shows that: (i) pts with relapsed lymphomas could achieve long-term remission and are probably cured; (ii) the occurrence of second tumors deserves further attention.
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Farina, Lucia, Francesca Patriarca, Maddalena Mazzucchelli, Chiara Salvetti, Giulia Quaresmini, Marta Medeot, Daniele Vincenti, et al. "Allogeneic Stem Cell Transplantation Versus B-Cell-Receptor Inhibitors in 17p Deletion and/or Refractory Chronic Lymphocytic Leukemia: A Retrospective Comparative Analysis of 'Real Life' Approaches to High Risk Patients, on Behalf of Rete Ematologica Lombarda (REL) and Gruppo Italiano Trapianto Di Midollo Osseo (GITMO)." Blood 128, no. 22 (December 2, 2016): 4695. http://dx.doi.org/10.1182/blood.v128.22.4695.4695.
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Abstract Introduction: chronic lymphocytic leukemia (CLL) is an indolent disease, but 17p deleted (del) and/or patients who experience early relapse or not responding to chemoimmunotherapy have a very poor outcome. In these patients an allogeneic stem cell transplantation (alloSCT) is indicated, whenever possible. B-cell receptor inhibitors (BCRi) have shown high efficacy with a low toxicity, making the choice of an alloSCT challenging even in high risk patients. The aim of the study is to highlight the outcome of different clinical approaches available in the era of the new drugs. Method: this is a multicenter retrospective analysis on 88 high risk patients treated in 8 Italian Centers. Inclusion criteria were: i) age ≤ 70 years; ii) responding to one of the EBMT (European Bone Marrow Transplantation) criteria for elegibility to alloSCT: relapse within one year after purine-analogues or two years after chemioimmunoterapy or autologous-SCT (ASCT); de novo or acquired 17p del; iii) alloSCT from 2001. Patients who received BCRi before alloSCT or ineligible to alloSCT due to comorbidities were excluded. Patients were assigned to alloSCT or BCRi based on physician and/or patient choice or unavailability of a donor. The analysis started from the transplant date or the start date of BCRi therapy. Results: 50 patients (M/F: 42/8) received an alloSCT, and 38 (M/F 30/8) were treated with BCRi (ibrutinib n=28, rituximab-idelalisib n=10). Median age was 55 (range, 34-68) in alloSCT and 60 years (42-69) in BCRi (p=0.06). Time from diagnosis to alloSCT or BCRi was 59,4 (range, 5-210) and 86,3 months (1-211) (p=0.15), respectively. Fluorescence in situ hybridization (FISH) data were available in 34/50 (68%) alloSCT patients: 17p del was positive in 21 (62%) (de novo n=12, acquired n=8, unknown n=1). Elegibility criteria for alloSCT group were: early relapse n=11, refractory n= 7, ASCT relapse n=11, 17p del n=21 (of which 11 were also chemorefractory). FISH data were available in all BCRi patients: 17p del was positive in 26 (68%) (de novo n=8, acquired n=14, unknown n=4). Elegibility criteria for BCRi group were: early relapse n=2, refractory n= 9, ASCT relapse n=1, 17p del n=26 (of which 16 were also chemorefractory). AlloSCT group had more patients in early relapse or with a failed ASCT (p=0.03 and p=0.01). Heavy chain gene rearrangement was available in 26/50 (52%) alloSCT and 35/38 (92%) BCRi patients and was unmutated in 87% and 86%, respectively. The median number of previous therapy was 2 in both groups (alloSCT: range 1-7; BCRi: range 0-8, p=0.25). Reduced-intensity conditioning regimen was used in 48/50 alloSCT patients, and donor type was sibling in 19, matched unrelated in 26 and haploidentical in 5 cases. Disease status before alloSCT was complete remission (CR)=20, partial remission (PR)=17, stable/progressive disease (SD/PD)=13. The median follow-up was 33 months (1-134) and 14 months (3-32), respectively for alloSCT and BCRi group (p=0.0008). Two-year OS was 59% vs 79% in alloSCT and BCRi, respectively (p=0.32). The cumulative incidence of relapse at 2 years was 30% in alloSCT and 23% in BCRi, with a non-relapse mortality of 20% after alloSCT. Median PFS was 18,6 months (range 1-134) and 12,6 (range 3-24,6) in alloSCT and BCRi, respectively. Two-year PFS was 54% in alloSCT and 77% in BCRi (p=0.19). The main cause of treatment failure was disease progression. In the BCRi group, 8 patients achieved CR at the last follow-up, 5 patients relapsed and died of progressive disease (2 with Richter's transformation), 1 patient died of second cancer. In the alloSCT group, 17 patients were alive and in CR, 11 CR patients died of transplant-related-mortality (6 graft-versus-host disease, 2 infections, 1 embolism, 2 second cancers), 19 patients died in SD/PD at the last follow-up. Conclusions: these retrospective data showed that so far no significant difference in the outcome of 17p del and/or refractory CLL patients have been observed after either alloSCT or BCR inhibitors. The significant different follow-up of the two groups implies some limits: i) BCR inhibitors still have to show long term responses; ii) alloSCT results may improve over the next future by a better selection of eligible patients and the improvement of the transplant procedures. Hopefully, the combination of the two strategies will increase the chance of cure of poor risk CLL patients. Disclosures Reda: Roche: Membership on an entity's Board of Directors or advisory committees; Gilead: Research Funding.
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Todisco, Elisabetta, Fabio Ciceri, Elena Oldani, Maria Teresa Van Lint, Irene Donnini, Francesca Patriarca, Emilio Paolo Alessandrino, et al. "Validation of the Cibmtr Score in Predicting the Outcome of Hematopoietic Stem-Cell Transplantation in AML Patients Not in Complete Remission At the Time of Conditioning: A Retrospective Analysis On Behalf of the Gruppo Italiano Trapianto Di Midollo Osseo (GITMO)." Blood 120, no. 21 (November 16, 2012): 2005. http://dx.doi.org/10.1182/blood.v120.21.2005.2005.
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Abstract Abstract 2005 Background and Aim The dismal prognosis of AML patients undergoing allogeneic stem cell transplantation not in complete remission at time of conditioning poses challenging clinical decisions. In these patients, a recent, large retrospective analysis conducted by the CIBMTR showed that a myeloablative HCST can induce an overall 19% long term survival. Based on five adverse pretransplantation variables (first CR duration less than 6 months, circulating blasts, donor other than HLA-identical sibling, Karnofsky or Lansky score less than 90, and poor-risk cytogenetics) this analysis allowed to set up a pre-HSCT score (from 0 to ≥3) able to identify four risk groups defining a 3-years overall survival (OS) probability ranging from 6% up to 42% (Duval M, JCO 2010). However, this CIBMTR analysis was limited to patients with the following characteristics: a) de novo AML or secondary AML to a previous MDS b) patients receiving a TBI or busulfan based myeloablative conditioning regimens (MAC) and a BM or PB derived stem cell graft. Here we report data obtained in Italy in a similar cohort of AML patients that also included those receiving a reduced-intensity conditioning (RIC) regimen and those grafted with a cord blood unit. Study design, patients and transplants characteristics We retrospectively analyzed data reported to the GITMO registry by 20 Italian centers on 523 AML patients who underwent a first HSCT being not in complete remission (CR) at time of conditioning, between 1999 and 2010. The median age at HSCT was 47,6 years (18–72), the male/female ratio 50%. At diagnosis 71,5% were de novo AML, 23% were secondary to a previous MDS/CMML, while in 5,5% the AML was therapy related or secondary to a previous CMN. Before HSCT conditioning, patients were primary refractory (PIF) in 34%, in first or subsequent untreated relapse in 45% and 16%, respectively or an untreated MDS to AML evolution in 5%. Before HSCT, 79% of PIF received ≥2 chemotherapy cycles and for relapsed patients the duration of the first CR was < 6 months in 50%. An intermediate-II or adverse karyotype was detected in 43% of patients, a greater than 25% marrow blast infiltration or any level of peripheral blood (PB) blasts was found in 53% and a pre-HSCT Karnofsky score less than 90 was present in 38%. The stem cell source was the PB in 65%, the bone marrow in 28% and the cord blood in 6%. Donors were HLA identical sibling or matched unrelated donor in 69%, a family or unrelated mismatched in 25% and a cord blood unit in 6%. Anti-CMV antibodies were present in 87% of patients and in 66% of the donors, while donor-recipient pair were sex-matched in 50% of the cases. More than 60% patients received a MAC and 37% a RIC program. Results After HSCT, a myeloid and platelets engraftment was achieved in 87% of patients after a median of 17 (9–63) and 18 (2–117) days, respectively. Acute GVHD (grade ≥2 60%) was registered in 46% while chronic GVHD developed in 31%. The median follow up of the whole patients cohort was 5,36 months (0.09–133) while that of survivors was 26 months (1–133) with 96 patients alive and 77 leukemia-free. A multivariate analysis identified 7 pre-HSCT adverse variables that significantly influenced survival: an AML secondary to a previous chronic myeloproliferative neoplasm or a therapy related AML (HR 1,83, 95%CI 1,14–2,96, p 0,013), a relapsed AML with a first CR duration < 6 months (HR 1,39, 95%CI 1,06–1,82, p 0,018), an AML with a PIF after ≥2 chemotherapy cycles pre-HSCT (HR 1,74, 95%CI 1,11–2,74, p 0,016), an intermediate II/adverse cytogenetics (HR1,71, 95%CI 1,11–2,62, p 0,015), BM blasts ≥25% or any level of PB at HSCT (HR 1,65, 95%CI, 1,31–2,07, p 0.000) and a mismatched related/unrelated donor (HR 1,56, 95%CI, 1,23–1,98, p 0.000). At 3-years, the OS and LFS of our patients was 16% and 21%. Interestingly, when applied to our results, the CIBMTR score was fully validated in our patients with a 3-year survival rate decreased from 40% (score 0, HR1) to 26% (score 1, HR 1,39; 95%CI 0.88–2,12, p 0,142), to 18% (score 2, HR 1,58; 95%CI 1–2,43, p 0,04) to 5% (score 3, HR 2,83; 95%CI 1,71–4,16, p 0,000) (Figure 1). Conclusions Our results confirm that a) HSCT is a potentially curative option for a significant proportion of AML patients undergoing transplant not in remission, b) these patients may benefit from either a MAC or a RIC conditioning regimens and c) the CIBMTR score applied to this poor prognosis AML cohort is a useful tool for patient counseling and for planning the HSCT activity. Disclosures: No relevant conflicts of interest to declare.
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Rambaldi, Alessandro, Alessandra Algarotti, Caterina Micò, Paolo Corradini, Michele Falda, Emilio Paolo Alessandrino, Renato Fanin, et al. "In Vivo T Cell Depletion with Antithymocyte Globulin or Alemtuzumab for Unrelated Donor Stem Cell Transplantation with Reduced Intensity Conditioning: Results of a Multicenter Randomized Phase II Clinical Trial (The Global Study) From the Gruppo Italiano Trapianto Di Midollo Osseo (GITMO)." Blood 120, no. 21 (November 16, 2012): 221. http://dx.doi.org/10.1182/blood.v120.21.221.221.
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Abstract Abstract 221 Background and aim In vivo T cell depletion with either Antithymocyte Globulin (ATG) or Alemtuzumab (Alem) for GVHD prophylaxis is frequently included in reduced intensity conditioning (RIC). We recently reported the results of two Phase II studies performed by GITMO in high risk patients undergoing allogeneic stem cell transplantation (HSCT) using an unrelated donor (UD) after conditioning with either an ATG or Alem based RIC (Rambaldi et al.: Leukemia 2012). Since both these programs proved to be well tolerated and reasonably effective we compared them in a prospective randomized Phase II clinical trial (ClinicalTrial.gov Identifier: NCT00354120). Study design and Patients The composite primary end point was the efficacy (overall and event free survival) and the safety (infectious complications and GVHD) of the two conditioning regimens. In addition, the outcome of patients receiving an UD transplant was compared (by a time dependent analysis, correcting for time to transplant) to patients who were not randomized for the lack of a donor or any other reasons. From March 2005 to September 2008, 245 patients were registered into this study when the UD search was activated. Of these patients, 121 were randomized and 112 (AML n=27, NHL n=27, HD n=26, MDS n=14, B-CLL n=11, ALL n= 4, CML n= 2, and MF n= 1) underwent HSCT (median age 58 years, range 17–67). The 2 randomized groups were well balanced. All these patients were unfit for conventional transplants due to age (between 55 and 65 years for acute leukemias, myelodysplastic syndromes, chronic myeloid leukemia and myelofibrosis) or advanced disease (for Hodgkin and non-Hodgkin Lymphomas). A previous autologous transplant was performed in 49% of patients while 26% had received more than 3 courses of chemotherapy. Patients were randomized to the following RIC programs: program A, (Melphalan 30 mg/m2, Fludarabine 90 mg/m2, TBI 200cGy and Alem 80 mg) (n= 58) or program B, (Thiotepa 10 mg/Kg, Cyclophosphamide 100 mg/Kg, Melphalan 30 mg/m2 and ATG 7,5 mg/Kg) (n= 54). At transplant, 52 patients were in complete remission (CR), 38 patients were in partial remission (PR) while the remaining 22 patients had active disease. Of the 124 patients who were not randomized, 58 stopped the UD search because of death before randomization. Of the remaining 66 patients, 31 were transplanted with an alternative program and 35 were unable to proceed to HSCT. Results The median time of neutrophil and platelet engraftment was similar in the 2 study arms (18 vs. 16 days and 18 vs. 18 days, respectively) but graft failure and graft rejection occurred most likely in arm A (9 vs. 1, p 0.036) and a better full donor chimerism in peripheral blood CD4+ cells was observed in arm B (93% vs. 68%, p 0.052). Of the 24 patients who had to be treated with DLI, 15 belonged to arm A and 9 to arm B (p 0.476). At day +100 the incidence of acute GVHD (> grade II) was slightly higher in the ATG arm (37% vs. 26%, p 0.224) but a higher incidence of late occurring acute GVHD occurred in the Alem arm, most likely because of DLI (5/6 patients, all with GVHD > grade III). The incidence of chronic GVHD was similar (40% and 41%) in both treatment arms. The immunologic reconstitution (time to CD4+ cells > 100/mcl) was slower in arm A (174 vs. 113 days, p 0.058) but no significant difference was observed in the incidence of viral, bacterial or fungal infections. A similar incidence of CMV disease (10% vs. 6% in arm A and B, respectively) and PTLD (5% in A vs. 11% in B) was observed. With a median follow up of 15 months (range 1–39), at 2 years, the non-relapse mortality (NRM) (36% vs. 35%) and the relapse rate (34% vs. 25%, p 0.294) do not differ in the 2 arms. Similarly, despite a trend for a better outcome for patients randomized to arm B, no significant difference was observed in terms of EFS (29% vs. 41%, p 0.295) and OS (36% vs. 52%, p 0,206) (Figure 1). By a multivariable model for the prediction of OS, a significant decrease of the risk of death was associated with the incidence of acute (p= 0.02) and chronic GVHD (p <0.001). At 3 years, the OS of randomized and non-randomized patients is similar (43% vs. 34%, p= ns). Conclusion A better engraftment and immune reconstitution as well as a trend for a lower relapse rate was observed in patients receiving an ATG based RIC. GVHD confirms its protective role on the risk of death confirming that an accurate dosing of in vivo T cell depleting agents is crucial for the long term clinical outcome after HSCT. Disclosures: No relevant conflicts of interest to declare.
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Farris, A. G., R. Caddeu, G. S. Podda, and A. Vacca. "ASPERGILLOSI INVASIVA IN PAZIENTE SOTTOPOSTA A TRAPIANTO DI MIDOLLO OSSEO ALLOGENICO." Microbiologia Medica 19, no. 2 (June 30, 2004). http://dx.doi.org/10.4081/mm.2004.3940.
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Gerna, G., F. Locatelli, E. P. Alessandrino, D. Lilleri, M. Furione, M. Gatti, M. Zavattoni, M. Torsellini, and F. Baldanti. "CONFRONTO TRA VALORI SOGLIA DI DNAEMIA E PP65-ANTIGENEMIA NELLA TERAPIA PRESINTOMATICA DELLE INFEZIONI DA CITOMEGALOVIRUS UMANO (HCMV) NEI PAZIENTI RICEVENTI TRAPIANTO ALLOGENICO DI CELLULE STAMINALI EMOPOIETICHE. ANALISI PRELIMINARE." Microbiologia Medica 19, no. 2 (June 30, 2004). http://dx.doi.org/10.4081/mm.2004.3761.
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Patriarca, Francesca, Alessandra Sperotto, Francesca Lorentino, Elena Oldani, Sonia Mammoliti, Miriam Isola, Alessandra Picardi, et al. "Donor Lymphocyte Infusions After Allogeneic Stem Cell Transplantation in Acute Leukemia: A Survey From the Gruppo Italiano Trapianto Midollo Osseo (GITMO)." Frontiers in Oncology 10 (October 15, 2020). http://dx.doi.org/10.3389/fonc.2020.572918.
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Cioce, Marco, Ivan Borrelli, Lorella Cappucciati, Manuela Giori, Giorgia Gobbi, Roberto Lucifora, Patrizia Mabilia, et al. "The impact of education on patients’ psycho-emotional status during allogeneic hematopoietic stem cell transplantation: a multicenter prospective study by thes Gruppo Italiano Trapianto di Midollo Osseo." Journal of Psychosocial Oncology, February 24, 2023, 1–17. http://dx.doi.org/10.1080/07347332.2023.2181722.
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