jRCT2061240069RecruitingNot Applicable
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)
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Daiichi Sankyo Co., Ltd.
- Enrollment
- 700
- Primary Endpoint
- -
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized Controlled Trial
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment Purpose
- Masking
- Double Blind
Eligibility Criteria
- Ages
- 18age old over to 70age old under (—)
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
-
Efficacy: Overall survival (OS)
Secondary Outcomes
No secondary outcomes reported
Investigators
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