Добірка наукової літератури з теми "DLT alternatives de consortium"
Оформте джерело за APA, MLA, Chicago, Harvard та іншими стилями
Ознайомтеся зі списками актуальних статей, книг, дисертацій, тез та інших наукових джерел на тему "DLT alternatives de consortium".
Біля кожної праці в переліку літератури доступна кнопка «Додати до бібліографії». Скористайтеся нею – і ми автоматично оформимо бібліографічне посилання на обрану працю в потрібному вам стилі цитування: APA, MLA, «Гарвард», «Чикаго», «Ванкувер» тощо.
Також ви можете завантажити повний текст наукової публікації у форматі «.pdf» та прочитати онлайн анотацію до роботи, якщо відповідні параметри наявні в метаданих.
Статті в журналах з теми "DLT alternatives de consortium":
1
Monje, Michelle, Tabitha Cooney, John Glod, Jie Huang, Patricia Baxter, Anna Vinitsky, Lindsay Kilburn, et al. "DIPG-10. A Phase I trial of panobinostat following radiation therapy in children with diffuse intrinsic pontine glioma (DIPG) or H3K27M-mutated thalamic diffuse midline glioma (DMG): Report from the Pediatric Brain Tumor Consortium (PBTC-047)." Neuro-Oncology 24, Supplement_1 (June 1, 2022): i19—i20. http://dx.doi.org/10.1093/neuonc/noac079.067.
Анотація:
Abstract INTRODUCTION: Panobinostat is an oral HDAC inhibitor with pre-clinical activity against DIPG. The phase I study in children with progressive DIPG (stratum 1) defined the maximum-tolerated dose (MTD) as 10 mg/m2 administered 3x/week, 3 weeks on/1 week off. Herein, we report results of stratum 2, involving children with non-progressive DIPG/DMG using an alternative schedule. Primary objectives were to describe the toxicity profile and define the MTD; secondary objectives were to describe progression-free survival (PFS) and overall survival (OS). PATIENTS AND METHODS: Patients with non-progressive DIPG or H3K27M-mutated thalamic DMG were eligible >14 days following standard radiation therapy only. Panobinostat was given every other day, 3x/week, on alternate weeks. Patients who received at least one dose of panobinostat were evaluable for toxicity. Four dose levels (DL) were evaluated: DL1 (16mg/m2/dose), DL2 (22 mg/m2/dose), DL3 (28 mg/m2/dose) and DL4 (36 mg/m2/dose). Dose escalation was determined by a continuous reassessment method. Correlative studies included pharmacokinetics obtained on course 1, day 1, and day 3 prior to subsequent dosing. RESULTS: Thirty-four eligible patients (median age, 7.6 [3-16] years) were enrolled with 29 evaluable for dose finding; DL1, n=3; DL2, n=10; DL3, n=11; DL4, n=5. The primary toxicities were myelosuppression and gastrointestinal. Eight DLTs occurred: DL2, Grade 3 thrombocytopenia (n=1); DL3, Grade 4 neutropenia (n=3), Grade 4 neutropenia and Grade 4 thrombocytopenia, (n=1); DL4, Grade 2 nausea (n=1), Grade 3 increased ALT (n=1), Grade 4 thrombocytopenia (n=1). Median PFS from drug initiation was 4.4 (1-11.2) months; median OS from diagnosis was 11.7 (4.5-25) months. These did not significantly differ from the PBTC historical cohort (PFS, p-value 0.4967; OS, p-value 0.6457). CONCLUSION: The MTD of panobinostat administered on this schedule to children with non-progressive DIPG/DMG is 22 mg/m2/dose. The primary DLT was myelosuppression. There was no significant improvement in PFS or OS in this cohort.
2
Shah, Nirali N., Sarah K. Tasian, M. Eric Kohler, Emily M. Hsieh, Susanne H. C. Baumeister, Corinne Summers, Haneen Shalabi, et al. "CD33 CAR T-Cells (CD33CART) for Children and Young Adults with Relapsed/Refractory AML: Dose-Escalation Results from a Phase I/II Multicenter Trial." Blood 142, Supplement 1 (November 28, 2023): 771. http://dx.doi.org/10.1182/blood-2023-179667.
Анотація:
Introduction: Current therapies for patients with acute myeloid leukemia (AML) push the limits of chemotherapy intensity but cure only 30% of adults and 70% of children. Recently developed antibody-based therapies and molecularly-targeted agents only modestly improve outcomes for select patient subsets. Thus, new approaches are needed. Given the success of chimeric antigen receptor (CAR) T-cell therapies for acute lymphoblastic leukemia (ALL), we developed and optimized a novel CD33 CAR T-cell (CD33CART) construct for clinical testing in a multicenter Phase I/II clinical trial in children, adolescents, and young adults (AYA) with relapsed/refractory (r/r) AML. ( Qin H, et al. JITC 2021) We report interim results following completion of the dose-escalation phase. Methods: This multicenter phase I/II clinical trial (NCT03971799) was conducted as a 3+3 dose escalation study through the Pediatric Transplantation and Cell Therapy Consortium with National Marrow Donor Program sponsorship and managed by CIBMTR CRO. Autologous CD33CART product were centrally manufactured on a ClinicMACS Prodigy® by the Biopharmaceutical Development Program at the Frederick National Laboratory for Cancer Research (NCI). Eligibility criteria were r/r AML in subjects < 35 years old with adequate organ/performance status and an identified allogeneic stem cell transplant (SCT) donor. Bone marrow assessment was used for standard morphologic evaluation and central flow cytometric minimal residual disease (MRD) quantification. All subjects received pre-CD33CART lymphodepleting chemotherapy (LD) with fludarabine (75-120 mg/m 2) and cyclophosphamide (900-1000 mg/m 2). CD33CART doses levels (DLs) were: DL1: 3 x 10 5 CD33 CAR+ T-cells/kg; DL2: 1 x 10 6/kg; DL3: 3 x 10 6/kg and DL4: 1 x 10 7/kg. Adverse event grading used CTCAE v5 with incorporation of ASTCT consensus definitions for cytokine release syndrome (CRS) and immune effector cell associated neurotoxicity syndrome (ICANS). Dose-limiting toxicities (DLTs) included > grade 3 CRS, > grade 3 ICANS, and persistent > grade 3 non-hematologic toxicity that did not resolve < grade 2 in 72 hours. CD33CART persistence was assessed via flow cytometric evaluation of the blood and bone marrow. Data cut-off was June 1, 2023. Results: A total of 24 subjects (median age of 16 years, range 1-34 years), were enrolled, 12 (50%) of whom underwent a prior SCT. CD33CART products were successfully manufactured for 23 subjects and infused into 19. In 4 non-infused subjects with manufactured products, 1 died from progressive disease (PD) prior to LD, 2 transitioned to palliative care and 1 withdrew consent to seek alternative therapy. Manufacturing was not performed in one subject due to death from PD after enrollment. One morbidly obese subject (BMI=49.3) enrolled at DL4 but received treatment at DL3 due to weight-based manufacturing limitations. The median time from enrollment to infusion was 47 days (range, 24-242). (Table) Three subjects each were infused at DL1 and DL2 without DLTs. At DL3, 1 subject experienced DLT (grade 4 CRS) prompting expansion at this dose level, and no subsequent DLTs were observed. At DL4, 1 subject experienced a prolonged grade 3 CRS (> 72 hours) and grade 3 ICANS, both constituting DLT and necessitating expansion of the cohort without additional DLTs seen. Across all dose-levels, CRS was seen in 13 (68%) patients and was > grade 3 in 4 (21%) with onset typically within the first 24 hours post-infusion. Complete remission (CR) was only seen at DL4 and achieved in 2 subjects, both achieving an MRD negative CR alongside myeloid aplasia. One SCT naïve subject developed candidemia during aplasia but was able to proceed to an allogenic SCT, achieved engraftment, and was in remission at Day +100 post SCT. The second patient (post-two prior SCTs) declined third SCT, had spontaneous count recovery and remained in remission until day +119 (MRD+ relapse). Transient CD33CART expansion was detected in 9 (47.4%) subjects overall and in all 6 (100%) subjects at DL4. Conclusions: CD33CART manufacturing is feasible in children and AYAs with r/r AML with acceptable toxicity experienced in treated subjects. CD33CART expansion was best in subjects treated at DL4 (1 x 10 7/kg) with MRD negative CRs and transient myeloid aplasia occurring in 2 of 5 (40%) subjects evaluable for response (Table). Based on early clinical efficacy at DL4, enrollment continues in the phase 2 portion.
3
Ebben, John, Jens C. Eickhoff, Dustin A. Deming, Howard S. Hochster, Anita Ahmed Turk, Vaibhav Sahai, and Nataliya Volodymyrivna Uboha. "QUIC: Phase 2 study of gemcitabine, cisplatin, quemliclustat (AB680), and zimberelimab (AB122) during first-line treatment of advanced biliary tract cancers (BTC)—Big Ten Cancer Research Consortium study BTCRC-GI22-564." Journal of Clinical Oncology 42, no. 16_suppl (June 1, 2024): TPS4195. http://dx.doi.org/10.1200/jco.2024.42.16_suppl.tps4195.
Анотація:
TPS4195 Background: Despite recent approvals of immune checkpoint inhibitors with chemotherapy in the first-line setting, the median overall survival (mOS) for patients with advanced biliary tract cancer (BTC) remains less than 15 months. CD73 is a key enzyme responsible for the conversion of extracellular adenosine 5’-monophosphate into adenosine and may play an important role in creating an immunosuppressed tumor microenvironment. High expression of CD73 in BTC is associated with decreased OS. Quemliclustat (Q) is a potent, selective, reversible inhibitor of CD73. Q in combination with chemotherapy has demonstrated promising activity in patients with advanced pancreatic cancer without significant increase in adverse events. The BTCRC-GI22-564 study evaluates safety and preliminary efficacy of Q in combination with zimberelimab (Z), a monoclonal antibody targeting human PD-1, with gemcitabine and cisplatin (GC) as first-line therapy for patients with advanced BTC, QUIC (Q and Immunotherapy in Cholangiocarcinoma). Methods: This is an open label, single arm, phase II multi-site trial, evaluating Q and Z in combination with GC in patients with advanced BTC who have not received systemic treatment for advanced disease or who completed adjuvant therapy > 6 months prior to development of recurrent disease. Chemotherapy is given on days 1, 8, 22 and 29 of each 42-day cycle as per local standards. Z is administered at a fixed dose of 360 mg via IV infusion every 3 weeks. Q is administered via IV infusion on days 1, 15, and 29. A safety run-in portion built into the study is planned to enroll 6 subjects to ensure there are no dose limiting toxicities (DLT). If a study defined DLT is observed, Q, gemcitabine and cisplatin will be reduced by 1 dose level, and an additional 6 subjects will be enrolled in the safety run-in portion. The primary efficacy endpoint is median progression free survival (mPFS) with null and alternative survival of 6.0 and 10.0 months, respectively. Based on an accrual rate of 3 patients per month, we expect to accrue 33-39 patients which will provide at least 83% power with a one-sided alpha of 0.1. Secondary endpoints include mOS, disease control rate, overall response rate, and duration of response. Correlative endpoints will assess clinical outcomes with immune infiltration within tumor microenvironment, CD73 and PD-L1 expression. The QUIC study is currently open to enrollment through BTCRC. Clinical trial information: NCT06048133 .
4
Islam, Md Rafiqul, Muhammad Mahbubur Rahman, Mohammed Ataur Rahman, Muslin Har Sani Mohamad, and Abd Halim Embang. "A Review on Blockchain Technology for Distribution of Energy." International Journal of Engineering Materials and Manufacture 7, no. 2 (April 22, 2022): 61–70. http://dx.doi.org/10.26776/ijemm.07.02.2022.03.
Анотація:
The alternative energy generation sources have increased drastically from centralized systems to distributed systems which increases the stability of energy distribution management systems and reduces the distribution cost as well. On the other hand, it reduces the probability of major area electricity blackout chances and decreases the energy distribution loss. For proper distribution and management of energy, there are different types of advanced technologies like artificial intelligence, and the Internet of Things (IoT) available, but a blockchain automated system is one of the best choices and is highly recommended. Various aspects of blockchain technology and energy management system have been discussed in this review paper where a total number of 423 journal papers, articles, and online information sources have been reviewed in the initial stage, and finally, 63 published research articles have been selected for review. There are several topics, including technology overview in energy management systems, blockchain application of energy trading, blockchain technology implementation challenges, distributed energy management system with Ethereum, and a conclusion with some recommendations have been discussed. Blockchain and Distributed Ledger Technology (DLT) are highly transparent, authenticate, and secure systems that can be used for distributing the energy between distributor and consumer without an intermediator which increases the overall efficiency of the system. This paper aims to highlight the blockchain and distributed ledger technology and how it works as well as optimize the transaction processing cost among the participants of the consortium network. This paper will make a significant contribution to the new research work and in the field of energy management systems.
5
Poh, Christina, Paul Frankel, Christopher Ruel, Mehrdad Abedi, Emily Schwab, Caitlin L. Costello, Jasmine Zain, et al. "Blinatumomab/Lenalidomide in Relapsed/Refractory Non-Hodgkin's Lymphoma: A Phase I California Cancer Consortium Study of Safety, Efficacy and Immune Correlative Analysis." Blood 134, Supplement_1 (November 13, 2019): 760. http://dx.doi.org/10.1182/blood-2019-124254.
Анотація:
Introduction Both blinatumomab and lenalidomide have proven, but limited, efficacy in relapsed/refractory (R/R) non-Hodgkin's lymphoma (NHL). Failure of blinatumomab to mediate durable responses is due to its inability to recruit competent cytotoxic T cells which leads to eventual T cell exhaustion. Lenalidomide has been shown to improve efficacy of rituximab through T and NK cell activation even in patients who have previously failed rituximab containing regimens. Based on this, we hypothesized that lenalidomide, when combined with blinatumomab, will enhance its efficacy. We report safety, efficacy and correlative analysis of blinatumomab and lenalidomide in R/R NHL. Methods We conducted a phase I, open-label trial involving patients 18 years and older with R/R CD19+ NHL who have received at least two prior chemotherapeutic or biologic regimens and were not eligible for standard curative options at time of enrollment. Previous CD19-targeted therapy was allowed. Study consisted of a dose escalation followed by a dose expansion phase once the maximum tolerated dose (MTD)/ recommended phase II dose (RP2D) was established using a Phase I Queue modified 3+3 design. The escalation phase has been completed and consisted of blinatumomab continuous infusion (level 1 and 2: 9 mcg/day to 112 mcg/day) from days 1-56 and lenalidomide (level 1: 10 mg and level 2: 20 mg daily) days 29-49 of a 56-day induction cycle. Patients who responded underwent consolidation with blinatumomab continuous infusion days 1-7 and lenalidomide days 1-21 of a 28-day cycle for a maximum of 6 cycles followed by lenalidomide maintenance for 2 years or until unacceptable toxicity or disease progression. Dose limiting toxicities (DLT) included any grade 3/4 drug related adverse events (AE) observed during and up to 7 days after blinatumomab/lenalidomide simultaneous administration. Additional patients were accrued to replace patients who had grade 3/4 AE or progressed before receiving lenalidomide for dose-finding purposes. Primary endpoints included toxicity and determination of the MTD/RP2D during the first 8 weeks of blinatumomab/ lenalidomide induction. Secondary endpoints included overall response rate (ORR), complete response (CR) rate, progression free survival (PFS) which was censored at time of transplant and immune response biomarkers. Results As of July 17, 2019, 18 patients initiated therapy; 7 with diffuse large B cell lymphoma, 3 with mantle cell lymphoma, 3 with follicular lymphoma, 2 with nonspecified B cell lymphoma and 1 each with marginal zone lymphoma, Burkitt's lymphoma and small lymphocytic lymphoma. Median age was 58 (range 30-84) years and the median number of prior regimens was 2.5 (range 2-5); 5 patients had previous stem cell transplant (SCT). 6 patients had disease progression prior to starting lenalidomide. 3 patients received blinatumomab/lenalidomide at dose level 1 with no DLT noted. 9 patients received blinatumomab/lenalidomide at dose level 2 with 4 requiring blinatumomab dose reduction prior to starting lenalidomide. Due to favorable safety profiles with the combination using the MTD/RP2D of lenalidomide 20 daily, upfront doublet therapy was initiated as part of the planned expansion phase. Most common grade 3/4 adverse events were lymphopenia (39%), hypophosphatemia (22%) and hyponatremia (11%). 1 patient (5.5%) experienced grade 3 neurotoxicity. No grade 3/4 cytokine release syndrome or treatment related deaths were seen. At time of data cutoff, three patients remain on active treatment. At a median follow-up time of 14.3 months, ORR was 56% for all patients and 83% (50% CR) for those who received blinatumomab/lenalidomide combination therapy. Median PFS was 3.8 months (95% CI, 1.1 to NR) for all patients and 8.3 months (95% CI, 2.2 to NR) for those who received blinatumomab/lenalidomide combination therapy. 3 patients who achieved response underwent allogeneic SCT and remained in remission for 14.2 to 22.3 months thereafter. Correlative studies are pending and will be reported at time of presentation. Conclusions The combination of blinatumomab and lenalidomide, given at the RP2D dose of 20 mg daily, is safe and well tolerated. This regimen demonstrates encouraging efficacy in this heavily pretreated patient population and is a promising alternative treatment option for R/R NHL patients who are not candidates for aggressive cytotoxic chemotherapy or as a bridge to allogeneic SCT. Disclosures Abedi: Abbie: Speakers Bureau; Takeda: Speakers Bureau; BMS: Speakers Bureau; Celgene: Speakers Bureau; Gilead: Speakers Bureau. Costello:Takeda: Honoraria, Research Funding; Janssen: Research Funding; Celgene: Consultancy, Honoraria, Research Funding. Zain:Seattle Genetics: Consultancy; Spectrum: Consultancy. Budde:F. Hoffmann-La Roche Ltd: Consultancy. William:Defined Health: Consultancy; Techspert: Consultancy; Celgene Corporation: Consultancy; Kyowa Kirin, Inc.: Consultancy; Guidepoint Global: Consultancy. Foss:Spectrum: Other: fees for non-CME/CE services ; Acrotech: Consultancy; miRagen: Consultancy; Eisai: Consultancy; Mallinckrodt: Consultancy; Seattle Genetics: Consultancy, Other: fees for non-CME/CE services . Jonas:AbbVie, Accelerated Medical Diagnostics, AROG, Celgene, Daiichi Sankyo, Esanex, Forma, Genentech/Roche, GlycoMimetics, Incyte, LP Therapeutics, Pharmacyclics: Research Funding; AbbVie, Amgen, Celgene, GlycoMimetics, Jazz, Pharmacyclics, Tolero: Consultancy, Membership on an entity's Board of Directors or advisory committees; AbbVie, Amgen, GlycoMimetics: Other: Travel expenses. Rosenberg:Amgen: Consultancy, Research Funding. Tuscano:Seattle Genetics: Honoraria; Amgen: Honoraria; Celgene: Honoraria, Research Funding; Novartis: Research Funding; Spectrum: Research Funding; Takada: Research Funding; Abbvie: Research Funding; Genentech: Research Funding; Pharmacyclics: Research Funding. OffLabel Disclosure: The use of blinatumomab and lenalidomide in patients with aggressive lymphoma
6
Phadke, Sneha, Kari Wisinski, Oana Danciu, Ami Shah, Menggang Yu, Yi Chen, Kathy Miller, and Mark Burkard. "Abstract PO1-06-09: Phase 2 Trial with Safety Run-In of Gedatolisib Plus Talazoparib in Advanced Triple Negative or BRCA1/2 Positive, HER2 Negative Breast CancersBig Ten Cancer Research Consortium BTCRC-BRE18-337." Cancer Research 84, no. 9_Supplement (May 2, 2024): PO1–06–09—PO1–06–09. http://dx.doi.org/10.1158/1538-7445.sabcs23-po1-06-09.
Анотація:
Abstract Up to 2/3 of triple negative breast cancers (TNBC) have acquired defects in homologous recombination (HR) DNA repair, yet poly (ADP-ribose) polymerase inhibitor (PARPi) monotherapy has been largely ineffective in the absence of a germline BRCA 1/2 mutation (gBRCA1/2). Phosphoinositide-3-kinase (PI3K)/mTOR pathway alterations are also common in breast cancers. Preclinical data suggest that PI3K/mTOR inhibition may disrupt normal function of the HR complex and increase dependency on PARP enzymes for HR DNA repair. Thus, combining a PI3K/mTOR inhibitor with a PARPi may result in a synergistic anti-neoplastic effect. The run-in portion of this study evaluated the safety of weekly IV gedatolisib (PI3K/mTORi) and continuous daily talazoparib to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). A 3+3 design for dose escalation explored two dose levels. The phase II study began once the MTD and R2PD were confirmed. Eligibility required age ≥ 18, 1-2 prior lines of therapy (protocol later amended to allow up to 3 lines), and advanced TNBC or advanced HER2-negative BC with gBRCA1/2 mutation. The sample size for the phase II study was determined based on a 1-sided binomial test under the null and alternative ORR of 5% vs 20% with a type I error rate of 0.1 and power level of 80%. The primary endpoint was overall response rate (ORR) in TNBC without known gBRCA1/2 with secondary endpoints of progression-free survival (PFS) and overall survival (OS). Patients with a gBRCA1/2 mutation were not included in the primary endpoint analysis. Correlative studies are planned to evaluate HR deficiency mutations, PIK3CA mutations, and other exploratory genomics. A total of 33 patients were enrolled: 14 in the safety run-in phase of the trial and 19 in the phase II study (17 TNBC, 2 with gBRCA2 mutation). In the safety run-in, 6 patients were enrolled at dose level 1 (0.75 mg talazoparib po daily and 180 mg gedatolisib IV weekly) and 8 at dose level 2 (1 mg talazoparib po daily and 180 mg gedatolisib IV weekly). 42% of the cohort developed hyperglycemia, which was mostly grade 1. There was 1 DLT of grade 3 neutropenia at dose level 1. There were 3 patients who experienced grade 4 AEs, thrombocytopenia (2) and lymphopenia (1) which were outside of the DLT window. The MTD was 1 mg of talazoparib daily and 180 mg of gedatolisib weekly, and this was selected as the RP2D. A protocol amendment was made during the phase II portion to allow for a 3 week on/1 week off schedule for gedatolisib due to emerging data showing a more favorable safety profile and enhanced antitumor activity with this dosing schedule. In the 17 patients with TNBC and no gBRCA mutation in the phase II cohort, the ORR was 12%. Best response was partial response (PR) in 2 patients (12%), stable disease (SD) in 7 patients (41%), and progressive disease (PD) in 8 patients (47%). The clinical benefit rate (ORR+SD) at 16 weeks was 23.5%. The most common adverse events (AEs) in all 33 patients were anemia (70%), fatigue (67%), oral mucositis (64%), nausea (60%), neutropenia (45%) and anorexia (45%). Of these, most were grade 1-2 other than anemia (35% grade 3), neutropenia (20% grade 3), fatigue (18% grade 3), and oral mucositis (10% grade 3). There were no grade 4 AEs in the phase II study. Median PFS was approximately 3 months and median OS was approximately 6.4 months. Although this study did not meet its primary endpoint, there were 2 TNBC patients without a gBRCA1/2 mutation who achieved a partial response to this non-chemotherapy regimen. Future biomarker testing may help elucidate these findings and possible predictors of response. Citation Format: Sneha Phadke, Kari Wisinski, Oana Danciu, Ami Shah, Menggang Yu, Yi Chen, Kathy Miller, Mark Burkard. Phase 2 Trial with Safety Run-In of Gedatolisib Plus Talazoparib in Advanced Triple Negative or BRCA1/2 Positive, HER2 Negative Breast CancersBig Ten Cancer Research Consortium BTCRC-BRE18-337 [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-06-09.
7
Wen, P. Y., T. Cloughesy, J. Kuhn, K. Lamborn, L. E. Abrey, F. Lieberman, H. I. Robins, J. Wright, M. D. Prados, and M. Gilbert. "Phase I/II study of sorafenib and temsirolimus for patients with recurrent glioblastoma (GBM) (NABTC 05–02)." Journal of Clinical Oncology 27, no. 15_suppl (May 20, 2009): 2006. http://dx.doi.org/10.1200/jco.2009.27.15_suppl.2006.
Анотація:
2006 Background: The activity of targeted molecular therapy with single agents has been disappointing in GBM. Combination therapy simultaneously targeting both the PI3k/Akt/mTOR and the MAP kinase pathway may be more effective. Methods: The North American Brain Tumor Consortium conducted a phase I/II study of sorafenib (VEGFR/PDGFR/Raf inhibitor) in combination with temsirolimus (mTOR inhibitor) in recurrent GBM. Eligibility criteria included histologically proven GBM, radiologic progression, > 18 years old, KPS > 60, adequate bone marrow reserve, and organ function. There was no limit on the number of prior relapses for phase I and no more than two prior relapses for phase II. No enzyme-inducing antiepileptic drugs were allowed. Dose-finding used a standard 3 + 3 design with the MTD defined as the dose with DLTs in 1/6 or fewer patients. The primary endpoint for the phase II component was PFS6 (p0 = 15%; p1 = 35%). A 2-stage design was used. If > 4 of the initial 19 patients achieved PFS6, an additional 14 patients would be accrued for a total of 33 patients. Results: In phase I, 13 patients were enrolled. Median age was 50 years (32–59); median prior chemotherapy 1 (1–3). The initial doses were sorafenib 200 mg bid and temsirolimus 25 mg intravenously once weekly. The MTD was 400 mg bid of sorafenib daily combined with 25 mg of temsirolimus weekly. At this dose 1/6 patients had a DLT (grade 3 thrombocytopenia). Other grade 3 or 4 toxicities included transaminitis, hypophosphatemia, fatigue, diarrhea, and hyperlipidemia. Pharmacokinetic data were similar to that for single agent sorafenib and temsirolimus suggesting that there were no significant interaction between the two drugs. In phase II, 19 patients were accrued to stage I. Median age 50 years (24–64); median prior relapses 1 (range 1–2). One patient was found not to have GBM on central review. No patient remained progression free at 6 months, although two patients stopped treatment prior to 26 weeks for other than progression (alternative therapy, cerebral ischemia). As result, the study was terminated and did not proceed to the second stage. Conclusions: The combination of sorafenib and temsirolimus was moderately well-tolerated but did not demonstrate sufficient efficacy in recurrent GBM to warrant further investigation. No significant financial relationships to disclose.
8
Minard, Charles Gene, Rachel Rau, Susan Hilsenbeck, Brenda J. Weigel, Elizabeth Fox, Peter Adamson, and Susan Blaney. "3488 A comparison between the Rolling 6 and 3+3 dose escalation study designs for phase 1 clinical trials." Journal of Clinical and Translational Science 3, s1 (March 2019): 30–31. http://dx.doi.org/10.1017/cts.2019.73.
Анотація:
OBJECTIVES/SPECIFIC AIMS: The development of new anti-cancer agents for children requires an inherently longer timeline than in adults. The 3+3 study design for Phase 1 dose escalation trials is commonly used to estimate the maximum tolerated dose and assess safety. The Rolling 6 study design was developed to shorten the study conduct timeline. METHODS/STUDY POPULATION: This study compares twenty Phase 1 COG Pilot and Phase 1 Consortium trials that employed the Rolling 6 design with hypothetical results under the assumption that a 3+3 design had been executed. The number of evaluable patients required to complete the study, number of DLTs, number of inevaluable patients, overall study duration, time suspended to enrollment (i.e., waiting for DLT evaluation), and DLT risk are compared between study designs using Wilcoxon’s signed rank test. RESULTS/ANTICIPATED RESULTS: The Rolling 6 study design required less time to complete the studies compared with 3+3 design (median 273 vs. 297 days, P = 0.01). In general, the Rolling 6 study design required more patients, had more inevaluable patients, and there were more dose limiting toxicity (DLT) events. However, there was no significant difference in DLT risk (median 0.15 vs. 0.17, P = 0.72). DISCUSSION/SIGNIFICANCE OF IMPACT: The Rolling 6 study design effectively shortens the study conduct timeline compared with the traditional 3+3 design for Phase 1 COG Pilot and Phase 1 Consortium trials without increasing the risk of toxicity.
9
Guo, Dong, and Peng Zhou. "The Evolution of Financial Market Infrastructure: From Digitalization to Tokenization." International Journal of Innovation and Entrepreneurship 2, no. 1 (March 8, 2023): 1. http://dx.doi.org/10.56502/ijie2010002.
Анотація:
This paper examines the historical development and cross-sectional heterogeneities of Financial Market Infrastructure (FMI). From an evolutionary perspective, we review and compare FMIs in the US, Europe, and China. We identify an emerging trend in which the development of FMI is transitioning from digitalization to tokenization with the rise of Distributed Ledger Technology (DLT). Digitalization reinforces centralization, while tokenization promotes decentralization, posing complex challenges to regulatory framework which is also part of FMI. We then specifically analyze DLT-based FMI in the bond market, evaluate different models of tokenization, and propose a heterogeneous consortium blockchain solution.
10
Mthethwa, Sthembile, and Morne Pretorius. "Academic and Skills Credentialing Using Distributed Ledger Technology (DLT) and W3C Standards: Technology Assessment." International Conference on Intelligent and Innovative Computing Applications 2022 (December 31, 2022): 170–82. http://dx.doi.org/10.59200/iconic.2022.019.
Анотація:
The ongoing push for the 4th industrial revolution is setting the stage to digitise, persist and verify identity along with credentials. Academic and skills credentials are currently verified manually and have much scope for automation using cryptographic techniques but requires standardisation to facilitate future systems interoperability. The Distributed Ledger Technology (DLT) and World Wide Web Consortium (W3C) Verifiable Credentials (VC) standards presents the possibility to achieve this credential verification automation. To accomplish this, an understanding of various DLTs and requirements for a viable skills tracking system is important. Therefore, this research aims to access the selected DLTs against the assessment criterion presented and an analysis has been completed to determine which DLT is suitable for the proposed system. The DLTs are assessed in terms of their ability to support the rapid prototyping of such a system and provide recommendations to guide a future development path from the perspective of standards compliance. We conclude that few DLTs possess the maturity to provide proper requirements coverage due to the emergent nature of the DLT space. Additionally, this paper presents the high-level requirements to achieve a minimally viable solution that can demonstrate such digital credential verification in the academic and skills tracking context.
Дисертації з теми "DLT alternatives de consortium":
1
Chehade, Imad. "Essais sur l'économie des technologies blockchain et des crypto-monnaies." Electronic Thesis or Diss., Normandie, 2023. http://www.theses.fr/2023NORMR057.
Анотація:
Cette thèse propose trois essais contribuant à déterminer les opportunités et les défis des technologies blockchain et des crypto-monnaies, afin de comprendre leur possibilité d’adoption dans le système bancaire et l’économie en général. Tout d’abord, nous avons montré, à travers une revue de littérature, des expérimentations pratiques, et une analyse comparative des différentes plateformes de DLT existantes, que les DLT alternative de consortium sont les prototypes qui devraient prédominer dans le système bancaire à l’avenir. Ensuite, nous avons mis en évidence la résistance et la résilience des principaux systèmes de récompenses utilisés par les pools de minage face aux événements du halving de Bitcoin. Cette comparaison est complétée par des calculs supplémentaires qui enrichissent véritablement l’analyse des décisions et des comportements des mineurs rejoignant un pool. Enfin, nous avons développé une solution de tokenisation adaptée pour le Liban, visant à assurer une reprise économique, tout en abordant le contexte économique tumultueux du pays et en étudiant les défis des solutions numériques existantesThis thesis presents three essays that contribute to determining the opportunities and challenges of blockchain technologies and cryptocurrencies, in order to understand their potential for adoption in the banking system and the economy in general. Firstly, we have demonstrated, through a literature review, practical experiments, and a comparative analysis of different existing DLT platforms, that consortium alternative DLTs are the prototypes likely to predominate in the banking system in the future. Next, we highlighted the resilience and robustness of the main reward systems used by mining pools in the face of Bitcoin halving events. This comparison is complemented by additional calculations that truly enrich the analysis of the decisions and behaviors of miners joining a pool. Finally, we developed a tokenization solution tailored for Lebanon, aimed at ensuring economic recovery, while addressing the country’s tumultuous economic context and examining the challenges of existing digital solutions
2
Andersson, Marcus, and Patric Sigvardson. "Embracing Blockchain : The Challenges of Collaborative Innovation Within the Financial Industry." Thesis, Uppsala universitet, Företagsekonomiska institutionen, 2018. http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-356479.
Анотація:
Creating standardized infrastructures for new technologies has become a frequent event in recent years, forcing competing firms to together collaborate in order to develop and mutually agree on a common standard. This is due to technologies such as blockchain (distributed ledger) technology that need interoperability to reach its full potential, making the collaboration aspect crucial for organizations that want to adapt to the technology. Therefore, this study’s purpose is to identify and analyze the challenges of creating such a standardized infrastructure. A case study was used to analyze these challenges, which involved experts of blockchain technology and three Nordic banks connected to the blockchain consortium R3. First, a pre-study took place with the help of blockchain experts, who helped identify potential problems regarding blockchain (distributed ledger) technology. Secondly, a main study was conducted consisting of four interviews with key persons representing the banks, in addition to collecting secondary data via news articles, and press releases. With the help of co-opetition theory and a technical description of blockchain (distributed ledger) technology, an analytical model was developed to support the analysis of the data collection. The analysis focus on aspects of co-opetition drivers, co-opetition capabilities, co-opetition dynamics and blockchain aspects, which were used to showcase the challenges of collaborating on creating a standardized infrastructure. The result of this study highlights the importance of learning and educational aspects, the size of a cooperation and threats from other competing solutions, which generates challenges. In addition to the identified challenges, this study has also contributed to an understanding of how these aspects can come to affect a collaboration.
Книги з теми "DLT alternatives de consortium":
1
Conservation, United States Congress Senate Committee on Energy and Natural Resources Subcommittee on Energy Regulation and. Iroquois Gas Transmission System: Hearing before the Subcommittee on Energy Regulation and Conservation of the Committee on Energy and Natural Resources, United States Senate, One hundredth Congress, first session, on the Iroquois Gas Transmission system--need, alternatives, and environmental impacts, Sandyhook, CT, July 20, 1987. Washington: U.S. G.P.O., 1987.
2
Tomich, Thomas P. Forest and agroecosystem tradeoffs in the humid tropics: A crosscutting assessment by the Alternatives to Slash-and-Burn Consortium (ASB), conducted as a sub-global component of the Millennium Ecosystem Assessment. Nairobi, Kenya: Alternatives to Slash-and-Burn Programme, 2005.
3
Tomich, Thomas P. Forest and agroecosystem tradeoffs in the humid tropics: A crosscutting assessment by the Alternatives to Slash-and-Burn Consortium (ASB), conducted as a sub-global component of the Millennium Ecosystem Assessment. Nairobi, Kenya: Alternatives to Slash-and-Burn Programme, 2005.
4
Thursfield, Rebecca, Chris Orchard, Rosanna Featherstone, and Jane C. Davies. Future treatments. Oxford University Press, 2015. http://dx.doi.org/10.1093/med/9780198702948.003.0013.
Анотація:
There are only a relatively limited armoury of drugs, the majority of which are aimed at downstream symptoms of cystic fibrosis. Therapies targeting the basic defect in CF as well as continued availability of more conventional drugs are required. Progress in gene therapy has been limited by the significant barriers to gene transfer of the CF lung, but the UK is hosting a large repeated dose trial of nebulized non-viral gene therapy designed around clinically meaningful outcomes. The UK CF Gene Therapy Consortium is also seeking to develop a promising modified lentiviral approach, although this is some years off. Perhaps the exciting development of recent decades has come from small molecule CFTR modulators, driven by an understanding of basic pathophysiological mechanisms. Ivacaftor is the first drug to be licensed, having proved itself highly clinically efficacious in patients with the class-3 gating mutation G551D. The trial pipeline seeks to expand indications for this and to explore the potential of Phe508del correctors. Finally, a number of anti-inflammatory and anti-infective strategies are being pursued. The emerging global problem of antibiotic resistance is leading to exciting alternatives such as biofilm disruption and bacteriophage to be explored.
Частини книг з теми "DLT alternatives de consortium":
1
Dowie, Jack, Mette Kjer Kaltoft, and Vije Kumar Rajput. "Measures of Decision Aid Quality Are Preference-Sensitive and Interest-Conflicted – 2: Empirical Measures." In Studies in Health Technology and Informatics. IOS Press, 2020. http://dx.doi.org/10.3233/shti200693.
Анотація:
Empirical measures of ‘decision aid quality’, like normative ones, are of a formative construct and therefore embody interest-conflicted preferences in their criteria selection and weighting. The preferences of the International Patient Decision Aid Standards consortium distinguish the quality of the decision-making process and the quality of the choice that is made ‘(i.e., decision quality)’. The Decision Conflict Scale features heavily in their profile measure of the former and Decision Quality Instruments (DQIs), have been developed by members of the consortium to measure the latter. We confirm that both of these, and other components, like the higher-level measures, are preference-sensitive and interest-conflicted. Non-financial interest-conflicted preferences are endemic in healthcare research, policy-making, and practice. That they are inevitable means the main problem lies in the denial of this and attitude to and behaviour towards alternatives, equally interest-conflicted.
2
Xavier, Letícia de Oliveira, Romano Roberto Valicheski, Eduardo Rodrigues de Carvalho, Lorena Martins Oliveira, Mateus de Sousa Peres, Jhonatan Lafaete Freitas Lourenço, Estenio Moreira Alves, and Flavio Lopes Claudio. "Cultivation systems, corn variety and Azospirillum - alternatives for small rural properties." In Themes focused on interdisciplinarity and sustainable development worldwide. Seven Editora, 2023. http://dx.doi.org/10.56238/tfisdwv1-174.
Анотація:
In the Western region of Goiás, the agricultural activity carried out by small producers predominates, many of which are dissatisfied with the production of corn for silage, due to its high production cost. Thus, it was evaluated the response of genetic materials of corn (variety SCS 154, SCS 156e hybrid Dow 2A620PW), grown in a solitary way and intercropped with pumpkin, with and without Azospirillum brasilense as inoculant for phytotechnical and productive aspects, seeking viable alternatives for family agriculture. The experiment was carried out in strips, sowing 1 hectare of corn and 1 hectare of pumpkin in monoculture; and, 1 hectare of corn + pumpkin in consortium. The sowing was performedon 11/15/2018, being for mechanized corn, and for pumpkin, manually. For pumpkin, higher productivity (13.11 t.ha-1) was obtained in the single system. For corn, there was no influence of cultivation systems on grain yield. The use of Azospirillum was efficient, providing better development in corn plants, however, there was a differentiated response of the genéticmaterials to the inoculant. The hybrid showed higher grain yield (5,536 kg.ha-1),, while the tested varieties showed higher dry mass production by shoots, making it promising in the production of bulky foods.
3
Stroup, Sarah S., and Wendy H. Wong. "INGOs and Corporations." In The Authority Trap. Cornell University Press, 2017. http://dx.doi.org/10.7591/cornell/9781501702143.003.0005.
Анотація:
Condemnation of corporate environmental and human rights performance has been something that some INGOs have become well-known for, yet not all INGOs elect to be publicly confrontational. We explore strategic choices through several examples of private, cross-sectoral regulations that emerged in the early 2000s. Leading INGOs are far more likely to collaborate and be asked to collaborate than other INGOs. Two platforms, The Sustainability Consortium (TSC) and the UN Global Compact (UNGC), leveraged early collaboration from a few leading INGOs to establish their credibility. We then explore the alternatives to collaboration. Though many INGOs condemn corporate behavior, little sustained attention has resulted from their efforts. Competition is possibly more fruitful for improving corporate practice, as the example of the Forest Stewardship Council (FSC) shows
4
Miriam, Goldby. "Part II Trade Finance Technology, 10 Digitalisation of Shipping and Insurance Documents: Implications for Trade Finance." In Trade Finance. Oxford University Press, 2021. http://dx.doi.org/10.1093/law/9780198854470.003.0010.
Анотація:
The inefficiencies inherent in processing pieces of paper manually down a cross-border chain of sales have prompted the international trade community to attempt to replace bills of lading with digital alternatives. These efforts have been ongoing for thirty years, but the recent availability of new technologies, particularly distributed-ledger technology (‘DLT’), which can be used in combination with ‘smart contracts’, the internet of things (‘IoT’) and machine-learning, has given these efforts a new impetus. Digitalisation holds many promises, including the creation of a context wherein new and cheaper financing options may be developed that do not involve manual checking of large volumes of paper documents. However, doing away with the paper-based documents of title creates uncertainties in terms of the bank’s position as secured creditor. Similarly, while cargo insurance certificates have been issued over electronic platforms for many years now, their transfer by endorsement is still effected by printing the certificate out and endorsing the paper-based certificate. In order for the benefits of digitalisation to be reaped in full, cargo insurance certificates also need to be fully digitalised, which would in turn raise questions as to the bank’s position as assured under the insurance contract. This chapter will examine the options available for making the bank’s position more certain. These options include legislative intervention and the development of contractual frameworks governed by English law.
Тези доповідей конференцій з теми "DLT alternatives de consortium":
1
Beites, Steven. "Performative Aesthetics: An Exploration into DLT-Ceramic Composite Wall Assemblies." In 108th Annual Meeting Proceedings. ACSA Press, 2020. http://dx.doi.org/10.35483/acsa.am.108.2.
Анотація:
The paper presents the early development of a novel mass timber-ceramic wall assembly that speaks to the importance of sustainable, performative and aesthetic potentials within the built environment. The work seeks to broaden the extensive body of research conducted on the robotic additive manufacturing of customized ceramic clay printing for large scale construction, exploring the possibilities of clay for its performative and formal capacity. It employs the use of an industrial robotic platform not as a device for automation, but for its ability to produce unique elements through a craft-based methodology in search of variability and specificity. Recognizing the limitation of ceramics as a load bearing material, it seeks to uncover its potential when combined with mass timber. As a result, dowel-laminated timber (DLT) is explored for its numerous advantages including structural efficiency, low toxic manufacturing processes, its inherent renewability and speed of construction. With the renewed interest in mass timber structures in recent years, we are nonetheless confronted with the realities of this unique natural material. Being both anisotropic and hygroscopic, wood’s inherent moisture-storage capacity makes it susceptible to water and air infiltration, vapor migration and condensation (Gagnon et al. 2013). Whether it be dowel-laminated or cross-laminated, timber’s sensitivity to moisture and its vulnerability to the elements renders itself unsuitable as a cladding application. Responding to this need, traditional cladding solutions for mass timber assemblies generally do not offer sustainable alternatives nor do they provide heightened aesthetic interest. As a result, the paper explores the production of material effects that go beyond superficiality by addressing the shortcomings of exposed mass timber wall assemblies through the development of a protective ceramic ventilated façade system that combines ornamental effects with performative criteria.
2
Valencia, Antonio Guijarro, Jeffrey A. Dixon, Riccardo Da Soghe, Bruno Facchini, Peter E. J. Smith, Julien Muñoz, Daniel Eastwood, Christopher A. Long, Daniel D. Coren, and Nicholas R. Atkins. "An Investigation Into Numerical Analysis Alternatives for Predicting Re-Ingestion in Turbine Disc Rim Cavities." In ASME Turbo Expo 2012: Turbine Technical Conference and Exposition. American Society of Mechanical Engineers, 2012. http://dx.doi.org/10.1115/gt2012-68592.
Анотація:
Reliable means of predicting ingestion in cavities adjacent to the main gas path are increasingly being sought by engineers involved in the design of gas turbines. In this paper, analysis is to be presented that results from an extended research programme, MAGPI, sponsored by the EU and several leading gas turbine manufactures and universities. Extensive use is made of CFD modelling techniques to understand the aerodynamic behaviour of a turbine stator well cavity, focusing on the interaction of cooling air supply with the main annulus gas. The objective of the study has been to benchmark a number of CFD codes and numerical techniques covering RANS and URANS calculations with different turbulence models in order to assess the suitability of the standard settings used in the industry for calculating the mechanics of the flow travelling between cavities in a turbine through the main gas path. The modelling methods employed have been compared making use of experimental data gathered from a dedicated two-stage turbine rig, running at engine representative conditions. Extensive measurements are available for a range of flow conditions and alternative cooling arrangements. The limitations of the numerical methods in calculating the interaction of the cooling flow egress and the main stream gas, and subsequent ingestion into downstream cavities in the engine (i.e. re-ingestion), have been exposed. This has been done without losing sight of the validation of the CFD for its use for predicting heat transfer, which was the main objective of the partners of the MAGPI Work-Package 1 consortium.
3
Robertson, Nicole, Jeffrey McNabb, Michael Balchanos, Alicia Sudol, and Dimitri Mavris. "A Design Decision-Support Environment for Evaluating the Impact of Ship Technologies." In SNAME 14th International Marine Design Conference. SNAME, 2022. http://dx.doi.org/10.5957/imdc-2022-353.
Анотація:
Modern naval missions rely increasingly on a complex array of electronic systems for a variety of functions including communications, sensing, weaponry, and countermeasures, greatly increasing the power requirements for future ships. To meet these needs, ships are transitioning to more electric architectures and require the infusion of new technologies. Since technology development resources are often limited, it is vital to intelligently choose the most promising designs to invest in. However, this type of decision-making is not necessarily straightforward. Firstly, the ship itself is a highly intricate system, with thousands of components and interactions that can be modeled at a variety of fidelity levels and time scales. Secondly, the final decision depends on the various objectives, sometimes conflicting, of each decision-maker involved in the process, making traceability and justification for the final selection a challenge. Therefore, there is a need for a design decision-support environment that brings together all the technical data about the performance aspects of various ship designs and technologies in a way that allows stakeholders to interact with the information in a more dynamic, traceable manner, in order to make more informed decisions. This paper is introducing an environment that is being created as part of a study with the Electric Ship Research and Development Consortium (ESRDC) on High-Temperature Superconducting (HTS) technologies sponsored by the U.S. Office of Naval Research (ONR) and presents some potential examples of how stakeholders could use it in the decision-making context. This environment is built upon the foundation of the Technology Identification, Evaluation, and Selection (TIES) methodology, originally formulated for aircraft design, now adapted for electric ships. TIES was developed to address the need for a design methodology that accounts for the uncertain nature of new technologies, integrating probabilistic analysis and other advanced design methods, as well as the multi-objective nature of modern design decision-making. The environment walks a user through the steps of the TIES methodology, starting from defining key objectives and metrics of interest and then moving to generation of a baseline and ship architecture alternatives via morphological analysis. Semi-automated modeling and simulation capabilities were then developed to enable the creation of a set of potential designs, allowing for a broader design space exploration than would be possible with traditional point-design-based processes, allowing the user to more clearly see the impact of lower-level ship parameters on system-level metrics of interest. Constraint and sensitivity analyses are then performed to gain a further understanding of the relationships and tradeoffs among the ship design variables, what regions of the design space are most promising, and what requirements most strongly impact the space of feasible designs. The environment then leverages the Technique for Order Preference by Similarity to Ideal Solution (TOPSIS) to allow users to dial in relative importance weightings of the system-level metrics of interest to determine which ship designs best meet their needs. Once several promising ship designs have been selected based on all the information shown in the environment, these options can be analyzed in more detail.
4
Carvalho, Cristina, Carla Costa Pereira, Gianni Montagna, and Carlos Manuel Figueiredo. "Biodyes: a new approach in textile dyeing and printing technological processes." In 14th International Conference on Applied Human Factors and Ergonomics (AHFE 2023). AHFE International, 2023. http://dx.doi.org/10.54941/ahfe1003641.
Анотація:
The textile industry is responsible for the production of more than 2 billion tons of effluents/waste, most of which are discarded into the ecosystem, namely and mostly into water ecosystems, essentially after the dyeing and printing processes. In fact, dyeing is one of the most polluting processes in the textile industry, representing a high source of pollution. According to the World Bank, the textile dyeing industries are responsible for more than 20% of the pollution of all water used at the industrial level.One of the serious problems related to the group of synthetic dyes is the level of chemical compounds used for their production, which has a high level of toxicity. In this context, the group of azo dyes stands out, for example, which predominate in most textile processing applications and have carcinogenic and mutagenic potential. These mentioned problems do not only have an impact in terms of the environment, but also in terms of human health since they can cause irritation to people's skin, eyes, and respiratory tract. Additionally, various health problems such as neurotoxicity, carcinogenicity, reproductive toxicity, and developmental toxicity can arise because of exposure to wastewater pollution.One of the emerging research domains is related to the exploration of obtaining natural dyes from microorganisms, known as Bio colorants. However, the approaches used also limit the yield and performance of the obtained formulations, since the dyeing process occurs directly, through the exposure of the microorganism to the substrate. Additionally, to date, there is no solution applicable to continuous dyeing.This research work has as its main objectives the research and development to obtain dyes for application in textile finishing processes, namely dyeing and printing, resorting to bacterial metabolic processes for the bioproduction of these same dyes. Complementarily, with this project, it is expected to obtain dyeing and printing processes with a reduction in contaminated effluents, because of the high biodegradability of the biodyes to be developed, thus contributing to the reduction of decontamination processes of industrial effluents.This project, therefore, aims to achieve the following research and development milestones:i. New biotechnological approach for obtaining the biodye;ii. High performance and functionalization of the biodye on textile substrates.iii. Reproducibility and uniformity of the process on various types of substrates.A differentiating approach will be investigated, through the metabolic study of the culture conditions of microorganisms, without resorting to genetic modification, and without the use of toxic chemical compounds, allowing, in this way, to generate a unique concept in the sector. As will be duly demonstrated given that, to date, Biodye solutions obtained from microorganisms for continuous dyeing are unknown.At the level of the proposed concept, it is intended to develop formulations of biodye in powder and/or liquid, with performances equivalent to synthetic dyes, to meet the facilities and operational needs of industrial textile dyeing and printing processes, directly responding to industry and market requirements. Effectively, this concept is unique and distinct in the sector, since the discontinuous dyeing solutions of biodyes (from microorganisms) available, occur by direct transfer of the color of the microorganism to the substrate, which entails high constraints in the productive processes in the industries of the sector, which do not have the capacity to adapt their infrastructures. The provision of a powder/and/or liquid formulation makes it possible to respond to this problem and needs.Within the scope of this research process, difficulties may be encountered in obtaining a sufficiently high production yield of biodyes using the different substrates to be tested. Although this is not expected for the production of the red biodye (using the E.coli microbiological strain), it may eventually occur in the production of the yellow and/or blue biodyes. In this case, the consortium team will investigate metabolic pathways of different bacterial and fungal strains to analyze alternatives for obtaining biodye with chromophores of different tones that are an added value for the needs of the sector, through the study and production based on Blakeslea trispora, or in fungi of the genus Penicillium. These strategies will enable the investigation of Biocolorant solutions with yields compatible with industrial needs.This research project also intends to demonstrate and validate the application of the biocolorant to textile ennoblement processes, in the specific case, industrial textile dyeing, and printing processes (batch and continuous) applied to a series of prototypes/pieces of clothing, with different compositions of textile fibers, for which it is intended to demonstrate high levels of intensity, saturation, and colorimetric solidity.