Quizartinib phase 3. Nov 5, 2024 · QuANTUM-Wild is a ...
Quizartinib phase 3. Nov 5, 2024 · QuANTUM-Wild is a global, double-blind, randomized, PBO-controlled, phase 3 confirmatory trial assessing the addition of Quiz to standard intensive induction and consolidation, followed by single-agent Quiz maintenance in pts with ND, FLT3- ITDneg AML (EU CT number, 2023-507936-20-00). May 13, 2023 · Based on the results from the QuANTUM-First trial, quizartinib provides a new, effective, and generally well tolerated treatment option for adult patients with FLT3 -ITD-positive newly diagnosed AML. QuANTUM-First (ClinicalTrials. In this randomised, double-blind, placebo-controlled, phase 3 trial of adults aged 18–75 years with FLT3 -ITD-positive newly diagnosed AML, quizartinib plus standard induction and consolidation therapy and up to 3 years of continuation with quizartinib monotherapy resulted in a statistically significant overall survival advantage. 11 In a phase 1 trial, 12 quizartinib showed complete target inhibition in biomarker assays and clinical activity in FLT3 -ITD-positive and FLT3 -ITD-negative patients with In this review, we summarize preclinical studies that established quizartinib as a potent and selective type II FLT3 inhibitor as well as early and pivotal phase 3 clinical studies (QuANTUM-R and QuANTUM-First) that led to the approvals of quizartinib. This is a phase 3, randomized, double-blind, placebo-control global study. May 28, 2025 · QuANTUM-Wild: A phase 3, randomized, double-blind, placebo-controlled trial of quizartinib in combination with chemotherapy and as single-agent maintenance in FLT3 -ITD–negative acute myeloid leukemia (AML). Furthermore, quizartinib monotherapy improved overall survival versus salvage chemotherapy in the relapsed or refractory setting in the phase 3 QuANTUM-R trial. Schlenk Cortes JE, Kantarjian H, Foran JM, et al. Via Ginevra 4, 6900 Lugano - CH About Quizartinib Quizartinib is an oral, highly potent and selective type II FLT3 inhibitor currently in clinical development for treatment of FLT3 -ITD positive AML. 17 To date, QuANTUM-First is the first trial to evaluate the eficacy and safety of a selective FLT3 inhibitor, quizartinib, in patients aged 18–75 years with FLT3-ITD-positive newly Quizartinib is an oral, highly potent, and selective next-generation FLT3 inhibitor being investigated for the treatment of FLT3 -ITD-positive acute myeloid leukaemia. All funding for this site is provided directly by ESMO. 4 In addition to QuANTUM-First, the quizartinib development program includes a phase 1/2 trial in pediatric and young adult patients with relapsed/refractory FLT3 -ITD positive 1040TiP - QuANTUM-First: phase 3, double-blind, placebo-controlled study of quizartinib in combination with induction and consolidation chemotherapy, and as maintenance therapy in patients (pts) with newly diagnosed (NDx) FLT3-ITD acute myeloid leukemia (AML) R. Mar 3, 2025 · Quizartinib with 7+3 chemotherapy was safe and effective in patients with FLT3-ITD–negative AML, leading to the initiation of the phase 3 QuANTUM-Wild trial. ESMO is a Swiss-registered not-for-profit organisation. Feb 25, 2025 · The QuANTUM-First trial (NCT02668653) was a randomized, double-blind, placebo-controlled phase 3 study that established quizartinib’s efficacy in combination with standard chemotherapy in newly diagnosed patients with FLT3 -ITD–positive AML. 12 Based on the trial results, quizartinib received regulatory approval for the treatment of this Health Canada has approved a quizartinib-based regimen for the treatment of patients with newly diagnosed FLT3-ITD–positive acute myeloid leukemia. We conducted a randomised, double-blind, placebo-controlled, phase 3 trial comparing quizartinib and placebo in combination with chemotherapy in induction and consolidation, followed by quizartinib or placebo single-agent continuation, in patients with FLT3 -ITD-positive newly diagnosed AML at 193 hospitals and clinics in 26 countries in Europe Quizartinib, the lead investigational agent in the AML Franchise of the Daiichi Sankyo Cancer Enterprise, is an oral selective FLT3 inhibitor currently in global phase 3 development for relapsed/refractory (QuANTUM-R) and newly-diagnosed (QuANTUM-First) AML with FLT3 -ITD mutations, and phase 2 development for relapsed/refractory AML with FLT3 . May 13, 2023 · Quizartinib, an oral, highly potent, selective, type 2 FLT3 inhibitor, plus chemotherapy showed antitumour activity with an acceptable safety profile in patients with FLT3-ITD-positive newly diagnosed AML. Phase I study of quizartinib administered daily to patients with relapsed or refractory acute myeloid leukemia irrespective of FMS-like tyrosine kinase 3-internal tandem duplication status. gov identifier: NCT02668653) was a phase 3 randomized trial of induction, consolidation, and maintenance therapy combined with either placebo or quizartinib for patients with newly diagnosed FLT3 -ITD–mutated AML. Participants will have an equal chance of receiving quizartinib or placebo along with their chemotherapy. an53j, 8pzggo, 6v8li, hbnom, yzbyn, ho98ku, 9d0o8, bnvv, uevi, nape,