Cathleen Maidlow. The 3-drug combination comprised of eprenetapopt, venetoclax, and azacitidine was found to induce a complete remission rate of 37% in patients with TP53-mutant acute myeloid leukemia. The safety and efficacy of these investigational agents and/or . In phase 3 study, the survival time of elderly patients with acute myeloid leukemia (AML), for whom there is no curative therapy option, was increased. The incidence of chronic GVHD did not exhibit any difference, with a 1-year incidence of 25.8% (95% CI, 17.4-35.1) with azacitidine and 30.8% (95% CI, 21.8-40) with observation. Analyze clinical trials with filters and metrics. Live. The superiority of the venetoclax combination was confirmed in two phase 3 trials comparing 5-azacitidine (AZA) or LDAC plus either venetoclax or placebo in newly diagnosed AML ineligible for intensive chemotherapy [8,9]. The primary objectives of this study are to compare the efficacy of magrolimab + venetoclax + azacitidine versus placebo + venetoclax + azacitidine in participants with previously untreated acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. A Phase 3, Randomized, Open-Label Study Evaluating the Safety and Efficacy of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Previously Untreated Patients With TP53 Mutant Acute Myeloid Leukemia. It has been announced that the VIALE-A trial ( NCT02993523 ), comparing venetoclax plus azacitidine to placebo plus azacitidine, has met the dual primary endpoints, with the combination therapy leading to a significant improvement in overall . - Data from Phase 3 VIALE-A study showed venetoclax plus azacitidine reduced the risk of death by 34% compared to azacitidine plus placebo in newly-diagnosed patients with AML who are ineligible for chemotherapy The Phase 3 VIALE-A study evaluated the efficacy and safety of venetoclax in combination with azacitidine compared with placebo in combination with azacitidine. 15 furthermore, azacitidine may reduce levels … Keywords The Verona study is a Phase 3, global, randomized, double-blind study to assess the safety and efficacy of venetoclax (an investigational drug) in combination with azacitidine, compared to placebo with azacitidine in subjects with newly diagnosed Higher-Risk MDS. Encourage 2L oral fluids daily during rump up phase. Study #2020-0180 A Randomized, Double-Blind, Phase 3 Study Evaluating the Safety and Efficacy of Venetoclax in Combination with Azacitidine in Patients Newly Diagnosed with Higher-Risk Myelodysplastic Syndrome (HR-MDS) MD Anderson Study Status Enrolling Treatment Agent Venetoclax, Azacitidine, Placebo Description AML: Venetoclax improves effectiveness of azacitidine. New England Journal of Medicine Publishes Positive Phase 3 Data of Venetoclax Combination in Acute Myeloid Leukemia (AML) Patients - Data from Phase 3 VIALE-A study showed venetoclax plus azacitidine reduced the risk of death by 34% compared to azacitidine plus placebo in newly-diagnosed patients with AML who are ineligible for chemotherapy Cycles repeat every 4-8 weeks in the absence of disease progression or unacceptable toxicity. March 23, 2020 AbbVie Announces Positive Topline Results from Phase 3 Trial of VENCLEXTA® (venetoclax) in Combination with Azacitidine in Patients with Acute Myeloid Leukemia (AML) - VIALE-A study demonstrated statistically significant improvement in the primary endpoints of overall survival (OS) and composite complete remission rate (CR + CRi) Study Design Go to Resource links provided by the National Library of Medicine Venetoclax-combinations are also being evaluated as maintenance strategies either after chemotherapy or after HSCT. Efficacy and safety of VENCLEXTA (venetoclax tablets) + azacitidine (VEN+AZA) were evaluated in a pivotal phase 3 trial 1,3. Contact Information. M15-531 is an ongoing study investigating the safety and pharmacokinetics of venetoclax plus azacitidine in approximately 137 patients with treatment-naïve higher-risk MDS. A phase 3 clinical trial is currently investigating the safety and efficacy of maintenance azacitidine plus venetoclax combination compared with supportive care in adult patients with AML post-HSCT ("VIALE-M", NCT04161885). The study is designed to evaluate the effect of venetoclax (at 400 mg dose) in combination with azacitidine on overall survival and remission rates as compared to the . Updated safety and efficacy of venetoclax with decitabine or azacitidine in treatment-naive, elderly patients with acute myeloid leukemia. The open-label, non-randomized, multicenter, dose-finding phase 1b study examined venetoclax plus azacitidine in treatment-naïve patients with higher-risk MDS. 3 "The ability of venetoclax plus . Researchers pooled data from two studies: the phase 3 VIALE-A trial, designed to compare venetoclax-azacitidine vs. placebo-azacitidine, and a phase 1B study in which all patients received . Results from the Phase III VIALE-A trial, published in the August 13, 2020 issue of the New England Journal of Medicine (NEJM), demonstrated that venetoclax (Venclexta®; Abbvie/Genentech), a drug used to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), in combination with azacitidine (Vidaza®; Celgene/Bristol Meyer Squibb) extended overall survival (OS) Cycle 1 AZACITIDINE 75 mg/m2 SC once daily Days 1 to 5 (Monday to Friday), weekend rest, then AZACITIDINE 75 mg/m2 SC once daily Days 8 to 9 (Monday to Tuesday), of 28 day cycle 15 furthermore, azacitidine may reduce levels … The median overall survival among patients who were randomly assigned to . The U.S. Food and Drug Administration (FDA) has given Rafael approval to initiate pivotal Phase 3 clinical trials in pancreatic cancer (AVENGER 500) and acute myeloid leukemia (ARMADA 2000), and . Results from the phase 1b M15-531 study (NCT02942290) supported the BTD. Blood 130 , 2628-2628 (2017 . Venetoclax (VEN) belongs the BH3-mimetic class that selectively targets BCL-2, activating apoptosis. Adults age ≥18 years with newly diagnosed AML ineligible for intensive chemotherapy were enrolled in this international phase 3 randomized double-blind placebo-controlled trial. Part 3 will be the Dose Finding portion to determine levels of venetoclax in combination with Azacitidine (CC-486) to be explored. 1 A 2018‐published report of 410 patients with MPN‐BP included 248 patients from the Mayo . A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of Venetoclax in Combination with Azacitidine Versus Azacitidine in Treatment Naive Subjects with Acute Myeloid Leukemia who are Ineligible for Standard Induction Therapy Patients receive venetoclax orally (PO) once daily (QD) on days 1-7 or 1-14 and azacitidine subcutaneously (SC) or intravenously (IV) over 15 minutes on days 1-5. A phase 3 clinical trial (VERONA) was launched comparing azacitidine plus venetoclax to azacitidine plus placebo for the treatment of frontline higher risk MDS based on these encouraging data. The combination of VEN and azacitidine (AZA) has changed the paradigm of treatment of newly diagnosed (ND) acute myeloid leukemia (AML) patients ineligible for intensive chemotherapy. Venetoclax (VEN) belongs the BH3-mimetic class that selectively targets BCL-2, activating apoptosis. In the pivotal Phase III VIALE-A and VIALE-C studies, complete response rates were superior with venetoclax combination therapy compared to azacitidine (66% vs 28%), and low-dose cytarabine alone . Methods: This phase 3, randomized, double-blind, placebo-controlled study (NCT02993523) is designed to assess VEN plus AZA compared with placebo plus AZA in treatment-naïve elderly and adult patients with AML who are not eligible for standard induction therapy due to age or comorbidities. According to results from the phase 3 VIALE-A trial, the combination use of venetoclax (Venclexta) and azacitidine (Vidaza) was safe and improved overall survival (OS) over azacitidine alone in certain patients with acute myeloid leukemia (AML). Patients (N = 211) were randomized 2:1 to venetoclax (n = 143) or placebo (n = 68) in 28-day cycles, plus low-dose cytarabine (LDAC) on days 1 to 10. cycle 1 day 1 before venetoclax dosing with 1.5-2 L/day fluids orally and/or intravenous administration. The phase 3 VIALE-A trial evaluated venetoclax combined with azacitidine (n = 286) versus azacitidine alone (n = 145) in adult patients with newly diagnosed AML who were considered ineligible for . Toxicity A phase 3 randomized, double-blind, placebo controlled study of venetoclax in combination with azacitidine versus azacitidine in treatment naive subjects with acute myeloid leukemia who are ineligible for standard induction therapy Endpoints Primary venetoclax, a potent, selective, oral inhibitor of bcl-2, has demonstrated single-agent clinical activity and a tolerable safety profile in patients with relapsed or refractory aml. The incidence of grade 3 to 4 aGVHD was low in both groups: 4.3% (95% CI, 1.4-9.9) with azacitidine and 2.1% (95% CI, 0.4-6.8) with observation. Houston "A combination with the BCL-2 antagonist venetoclax can increase the effectiveness of the cytostatic agent azacitidine. Additional ongoing studies of the agents include the phase 1b M15-522 trial (NCT02966782) of venetoclax either alone or in combination with azacitidine for the treatment of patients with relapsed or refractory MDS and the phase 3 Verona trial (NCT04401748) of venetoclax with intravenous or subcutaneous azacitidine in newly diagnosed higher-risk MDS. The combination of VEN and azacitidine (AZA) has changed the paradigm of treatment of newly diagnosed (ND) acute myeloid leukemia (AML) patients ineligible for intensive chemotherapy. These presentations are scheduled for Session 721 , Abstract 190 on Saturday, Dec. 5 at 3:15 p.m., and Session 637 , Abstract 656 on Monday, Dec.7 at 3 . This phase 3, multicenter, randomized, double-blind, placebo-controlled trial was conducted to evaluate the efficacy and safety of azacitidine plus venetoclax, as compared with azacitidine plus . The hypotheses corresponding to the primary objective is that venetoclax will improve the complete remission (CR) rate and overall survival (OS) when added to standard of care azacitidine treatment in patients newly diagnosed with higher-risk MDS. This phase I trial studies the side effect and best dose of venetoclax, in combination with azacitidine, in treating patients with blastic plasmacytoid dendritic cell neoplasm that has come back, does not respond to treatment, or has never been treated. Looking ahead, results of a phase 3 randomized, double-blind, placebo-controlled study investigating venetoclax use in older AML patients are anticipated to be favorable . The study met its dual primary endpoints of OS and composite complete remission (CR + CRi). Full approval, which came in October 2020, awaited positive results of the phase 3 VIALE-A trial, published in the New England Journal of Medicine (NEJM) this past August. trial, venetoclax and azacitidine showed a CR/CRi rate of 75% of patients with ND IDH1/2mutAML with a median OS of 24.5 months.3 Herein, we describe the outcomes of patients with treatment naïve and previously treated IDH1/2mut AML, who were treated on a pro-spective phase 2 trial of 10-day decitabine with venetoclax (DEC10-VEN, NCT03404193).4 OUTLINE: This is a phase I, dose-escalation study of venetoclax followed by a phase II study. Blast phase (BP) transformation is the most feared complication in patients with myeloproliferative neoplasms (MPN) and its 20‐year estimated incidence was approximately 9% for primary myelofibrosis (PMF), 4% for polycythemia vera (PV) and 3% for essential thrombocythemia (ET). Encourage 2L oral fluids daily during rump up phase. Daily dose escalation of venetoclax was done in cycle 1, following the dosing schedule established in earlier phase 1 trials r r (100 mg day 1, 200 mg day 2, then the 400 mg target dose from day 3). Azacitidine Plus Venetoclax for the Treatment of Relapsed and Newly Diagnosed Acute Myeloid Leukemia Patients Sylvain Garciaz , 1, 2, * Marie-Anne Hospital , 2 Anne-Sophie Alary , 3 Colombe Saillard , 2 Yosr Hicheri , 2 Bilal Mohty , 2 Jérôme Rey , 2 Evelyne D'Incan , 2 Aude Charbonnier , 2 Ferdinand Villetard , 2 Valerio Maisano , 2 Laura . venetoclax, a potent, selective, oral inhibitor of bcl-2, has demonstrated single-agent clinical activity and a tolerable safety profile in patients with relapsed or refractory aml. Blood 138 (2021) 537â€"540 63rd ASH Annual Meeting Abstracts ORAL ABSTRACTS 637.MYELODYSPLASTIC SYNDROMES - CLINICAL AND EPIDEMIOLOGICAL Venetoclax and Azacitidine in the Treatment of Patients with Relapsed/Refractory Myelodysplastic Syndrome Amer M. Zeidan 1, Uma Borate 2, Daniel A. Pollyea 3, Andrew M. Brunner 4, Fernando Roncolato 5, Jacqueline S. Garcia 6, Robin J Filshie 7, Olatoyosi . In a phase 3 study of azacitidine and venetoclax in untreated acute myeloid leukemia not eligible for standard induction chemotherapy, the addition of venetoclax to azacitidine resulted in an improvement in median overall survival (14.7 months versus 9.6 months) and improved complete remission rates. 1 The results of this study showed this combination was more efficacious than azacitidine alone, with patients who received both . Efficacy and safety of VENCLEXTA (venetoclax tablets) + azacitidine (VEN+AZA) were evaluated in a pivotal phase 3 trial 1,3. Background: The combination of ivosidenib - an inhibitor of mutant isocitrate dehydrogenase 1 (IDH1) - and azacitidine showed encouraging clinical activity in a phase 1b trial involving patients with newly diagnosed IDH1-mutated acute myeloid leukemia. The exciting results with venetoclax in untreated unfit AML led to their off-label use in the R/R-AML setting. Important Safety Information Tumor Lysis Syndrome Cycle 1 AZACITIDINE 75 mg/m2 SC once daily Days 1 to 5 (Monday to Friday), weekend rest, then AZACITIDINE 75 mg/m2 SC once daily Days 8 to 9 (Monday to Tuesday), of 28 day cycle The team need 396 people to take part including about 20 to 30 people from the UK. VIALE-A (NCT02993523) is a randomized, double-blind, multicenter, placebo-controlled phase III study that compares venetoclax and azacitidine (Ven + Aza) versus placebo + Aza in patients with acute myeloid leukemia (AML) who are not eligible for intensive induction therapy. VIALE-A was a randomized (2:1), double-blind, placebo-controlled, multicenter, phase 3 clinical trial that evaluated the efficacy and safety of VEN+AZA vs placebo (PBO)+AZA in newly diagnosed patients with AML who were ≥75 years of age, or had comorbidities that . VIALE-A was a randomized (2:1), double-blind, placebo-controlled, multicenter, phase 3 clinical trial that evaluated the efficacy and safety of VEN+AZA vs placebo (PBO)+AZA in newly diagnosed patients with AML who were ≥75 years of age, or had comorbidities that . The study showed that venetoclax plus azacitidine reduced the risk of death by 34% compared to azacitidine alone, yielding median overall survival of 14.7 months vs 9.6 months. •. Trial Phase: Phase III. VIALE-A (NCT02993523) is a phase 3, randomized, double-blind, placebo-controlled and multicenter study that assessed the efficacy and safety of venetoclax-azacitidine compared with placebo-azacitidine in patients with previously untreated AML who were ineligible for intensive chemotherapy . Principal Investigator: Ginder, Gordon cycle 1 day 1 before venetoclax dosing with 1.5-2 L/day fluids orally and/or intravenous administration. Primary endpoint is event-free-survival of patients treated with venetoclax and azacitidine compared to patients treated with standard induction with either 7+3 regimen or liposomal daunorubicin and cytarabine Events are described in the protocol and will include Progressive Disease as defined above Results from the Phase III VIALE-A trial (M15-656; NCT02993523) of venetoclax (Venclexta®; AbbVie/Genentech) in combination with azacitidine (Vidaza®) versus azacitidine in combination with placebo demonstrated statistically significant improvement in the primary endpoints of overall survival (OS) and composite complete remission rate (CR + CRi), meeting is dual endpoints for patients with . The addition of venetoclax to azacitidine was associated with a 34% reduction in risk of death compared with placebo plus azacitidine, according to results of a phase 3 trial of adult patients . During this study, participants will receive venetoclax and azacitidine or best supportive care for approximately 2 years with study visits varying from 1-5 per month. Methods: In this phase 3 trial, we randomly assigned patients with newly diagnosed IDH1-mutated acute myeloid leukemia who were ineligible for . This is an international phase 3 trial. DiNardo, C. D. et al. Venetoclax (Ven) is a selective, potent, oral B-cell lymphoma-2 (BCL-2) inhibitor that is approved in the U.S. in combination with hypomethylating agents for treating older or co-morbid patients with newly diagnosed acute myeloid leukemia ineligible for intensive chemotherapy. There is scarce … The phase 3 VIALE-A study of venetoclax (Venclexta, AbbVie) in combination with azacitidine (Vidaza) in patients with acute myeloid leukemia (AML) showed a statistically significant improvement in overall survival (OS) and composite complete remission rate. Part 2 begins after Part 1 is completed. Phase 3 Study To Evaluate The Safety And Efficacy Of Magrolimab In Combination With Azacitidine Versus Physician's Choice Of Venetoclax In Combination With Azacitidine Or Intensive Chemotherapy In Previously Untreated Adults With TP53 Mutant Acute Myeloid Leukemia (ENHANCE-2) Part 2 begins after Part 1 is completed. 1. This decision was dependent upon the confirmatory phase III clinical trials, VIALE-A and VIALE-C. 1. Part 3 will be the Dose Finding portion to determine levels of venetoclax in combination with Azacitidine (CC-486) to be explored. Randomized, Open-label, 2-Arm, Multicenter, Phase 3 Study of Venetoclax and Azacitidine Versus Best Supportive Care as Maintenance Therapy for Patients with Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy (VIALE-M) National Clinical Trial Number: NCT04102020. The manuscript titled, "Azacitidine and Venetoclax in Previously Untreated Acute Myeloid Leukemia," was published in the August 13, 2020 issue of NEJM. ENHANCE-3: A Phase 3 Study Evaluating the Safety and Effectiveness of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Participants With Acute Myeloid Leukemia (AML) Schematic 1,2 ˝˝Other protocol-defined Inclusion and Exclusion criteria may apply. The trial is in 3 parts: in part 1 the team want to confirm the best dose of venetoclax to have with azacitidine; in part 2 they are comparing venetoclax, azacitidine and best supportive care to best supportive care A randomized phase 3 trial (VERONA; ClinicalTrials.gov Identifier: NCT04401748 ), the details of which were presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, is evaluating the safety and efficacy of venetoclax with azacitidine among patients with previously untreated, higher-risk myelodysplastic syndromes (MDS). - Data from Phase 3 VIALE-A study showed venetoclax plus azacitidine reduced the risk of death by 34% compared to azacitidine plus placebo in newly-diagnosed patients with AML who are ineligible . All patients were hospitalised for tumour lysis prophylaxis consisting of an oral uric acid reducing agent and oral hydration 72 hours prior to . This study will enroll approximately 500 patients from around the globe. Researchers pooled data from an ongoing phase 3 study comparing treatment with venetoclax plus azacitidine or placebo, and a phase 1b study of patients who received venetoclax and azacitidine . Relapsed AML patients will be allowed to enroll in the Escalation Phase of Regimens A, B, and C (IMGN632 + azacitidine, venetoclax, or azacitidine + venetoclax, respectively) and the Expansion Phase of Regimens A and B and may have received up to 2 prior lines of therapy; e.g., frontline treatment (induction, consolidation [including transplant . The dual primary endpoints for Japan were OS and CR . 2. AML is an aggressive and difficult to treat blood cancer with a very low survival rate. Venetoclax M15-656 Protocol EudraCT 2016-001466-28 1 1.0 Title Page Clinical Study Protocol M15-656 A Randomized, Double-Blind, Placebo Controlled Study of Venetoclax in Combination with Azacitidine PDF | Phase 3 trials Viale-A and Viale-C evaluated health-related quality of life (HRQoL) in patients with AML unfit for intensive chemotherapy who. In the pivotal Phase III VIALE-A and VIALE-C studies, complete response rates were superior with venetoclax combination therapy compared to azacitidine (66% vs 28%), and low-dose cytarabine alone. During this study, participants will receive venetoclax and azacitidine or best supportive care for approximately 2 years with study visits varying from 1-5 per month. AML develops mostly in older populations (with a median age between 68-72 years) where treatment options are limited . Courtney Dinardo, MD from MD Anderson Cancer Center discusses the results of the phase 3 VIALE-A study, examining the combination of venetoclax and azacitidine as treatment for acute myeloid leukemia (AML). INTRODUCTION. In this phase 1/2 study (NCT02265731), Japanese patients (≥60 years) with untreated (ineligible for induction chemotherapy) or relapsed/refractory acute myeloid leukaemia received oral venetoclax 400 mg/day (3-day ramp up in cycle 1) plus subcutaneous or intravenous azacitidine 75 mg/m 2 on days 1-7 per 28-day cycle until disease . 14 venetoclax in combination with azacitidine has demonstrated a synergistic effect in preclinical models of aml cells. Indication: VENCLEXTA is indicated in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. There is scarce … The Phase 3 VIALE-A study evaluated the efficacy and safety of venetoclax in combination with azacitidine compared with placebo in combination with azacitidine. | Find, read and cite all the research you . 14 venetoclax in combination with azacitidine has demonstrated a synergistic effect in preclinical models of aml cells. A: In this phase 3 trial involving patients with AML who had not received treatment previously and who were either elderly or otherwise ineligible to receive intensive chemotherapy, combination treatment with azacitidine plus venetoclax was superior to azacitidine alone. AbbVie issued the following announcement on Aug. 12. A Phase 3, Randomized, Open-Label Study Evaluating the Safety and Efficacy of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Previously Untreated Patients With TP53 Mutant Acute Myeloid Leukemia. Protocol # M15-954. 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