Trial Filter

BETA

An intelligent search tool for clinical trials

Sign In
Back|NCT06578247Recruiting
Official Title

A 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

Phase
Phase 3
Sponsor
Daiichi Sankyo
Enrollment
700
Timeline
Nov 2024 → Jun 2030
About This Study

This study will compare the effects of Quizartinib versus placebo in combination with chemotherapy in participants with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) negative acute myeloid leukemia (AML).

Eligibility Criteria

Inclusion Criteria

  • 1Must be competent and able to comprehend, sign, and date an Ethics Committee (EC)- or Institutional Review Board (IRB)-approved ICF before performance of any trial-specific procedures or tests.
  • 2≥18 years or the minimum legal adult age (whichever is greater) and ≤70 years (at Screening).
  • 3Newly diagnosed, morphologically documented primary AML based on the World Health Organization (WHO) 2016 classification (at Screening)
  • 4Eastern Cooperative Oncology Group (ECOG) performance status (at the time the participant signs their ICF) of 0-2.
  • 5Participant is a candidate for standard "7+3" induction chemotherapy regimen as specified in the protocol per investigator assessment

Exclusion Criteria

  • 1Diagnosis 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).
  • 2Diagnosis of AML secondary to prior chemotherapy or radiotherapy.
  • 3Diagnosis of AML with known antecedent myelodysplastic syndrome (MDS) or a myeloproliferative neoplasm (MPN) or MDS/MPNs including chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), juvenile myelomonocytic leukemia (JMML) and others.
  • 4Participants 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.
  • 5Prior treatment for AML, except for the following allowances prior to Day 1 of chemotherapy:
  • 6Leukapheresis;
  • 7Treatment for hyperleukocytosis with hydroxyurea;
  • 8Cranial radiotherapy for central nervous system (CNS) leukostasis;
  • 9Prophylactic intrathecal chemotherapy

Locations

283 sites participating in this study

Winship Cancer Institute of Emory University

Atlanta, Georgia 30322

Recruiting

City of Hope Phoenix

Goodyear, Arizona 85338

Recruiting

Mayo Clinic - Phoenix

Phoenix, Arizona 85054

Recruiting
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →