Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial Of Quizartinib Administered in Combination With Induction and Consolidation Chemotherapy and Administered as Maintenance Therapy in Adult Patients With Newly Diagnosed FLT3-ITD Negative Acute Myeloid Leukemia (QuANTUM-Wild)

Daiichi Sankyo Co., Ltd.0 个研究点目标入组 700 人开始时间: 2025年2月19日最近更新: 2025年3月28日

适应症

试验速览

暂无简介。

•Must be competent and able to comprehend, sign, and date an Ethics Committee (EC)- or Institutional Review Board (IRB)-approved Informed Consent Form (ICF) before performance of any trial-specific procedures or tests.
•>=18 years or the minimum legal adult age (whichever is greater) and <=70 years (at Screening).
•Newly diagnosed, morphologically documented primary AML based on the World Health Organization (WHO) 2016 classification (at Screening)
•Eastern Cooperative Oncology Group (ECOG) performance status (at the time the participant signs their ICF) of 0-
•Participant is receiving standard "7+3" induction chemotherapy regimen as specified in the protocol

•Diagnosis of acute promyelocytic leukemia (APL), French-American-British classification M3 or WHO classification of APL with translocation, t(15;17)(q22;q12), or BCR-ABL positive leukemia (ie, chronic myelogenous leukemia in blast crisis); participants who undergo diagnostic workup for APL and treatment with all-trans retinoic acid (ATRA), but who are found not to have APL, are eligible (treatment with ATRA must be discontinued before starting induction chemotherapy).
•Diagnosis of AML secondary to prior chemotherapy or radiotherapy for other neoplasms or autoimmune/rheumatologic conditions.
•Diagnosis of AML secondary to myelodysplastic syndrome (MDS) or a myeloproliferative neoplasm (MPN) or MDS/MPNs including CMML, aCML, JMML and others.
•Participants with newly diagnosed AML with FLT3-ITD mutations (FLT3-ITD [+]) present at >=5% VAF (or >=0.05 SR) based on a validated FLT3 mutation assay.
•Prior treatment for AML, except for the following allowances:
•Leukapheresis;
•Treatment for hyperleukocytosis with hydroxyurea;
•Cranial radiotherapy for central nervous system (CNS) leukostasis;
•Prophylactic intrathecal chemotherapy;
•Growth factor/cytokine support.

Efficacy: Overall survival (OS)

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