Status:
RECRUITING
Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML
Lead Sponsor:
Daiichi Sankyo
Conditions:
Leukemia
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
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 (I...
Detailed Description
This is a clinical trial to compare the effect of quizartinib versus placebo (administered with standard induction and consolidation chemotherapy, then administered as maintenance therapy for up to 36...
Eligibility Criteria
Inclusion
- Key
- Must 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.
- ≥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 0-2.
- Participant is a candidate for standard "7+3" induction chemotherapy regimen as specified in the protocol per investigator assessment
- Key
Exclusion
- 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.
- Diagnosis 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.
- 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 prior to Day 1 of chemotherapy:
- Leukapheresis;
- Treatment for hyperleukocytosis with hydroxyurea;
- Cranial radiotherapy for central nervous system (CNS) leukostasis;
- Prophylactic intrathecal chemotherapy
Key Trial Info
Start Date :
November 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 26 2030
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT06578247
Start Date
November 19 2024
End Date
June 26 2030
Last Update
January 8 2026
Active Locations (291)
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1
City of Hope Phoenix
Goodyear, Arizona, United States, 85338
2
Mayo Clinic - Phoenix
Phoenix, Arizona, United States, 85054
3
University of Arizona Cancer Center
Tucson, Arizona, United States, 85724
4
David Geffen School of Medicine
Los Angeles, California, United States, 90095