Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML (NCT06578247) | Clinical Trial Compass
RecruitingPhase 3
Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML
United States700 participantsStarted 2024-11-19
Plain-language 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 (ITD) negative acute myeloid leukemia (AML).
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. 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
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.
✕. 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.
✕
What they're measuring
1
Overall Survival (Arm A vs Arm B)
Timeframe: Date of first patient randomized to the target number of deaths reached, up to approximately 42 months
Trial details
NCT IDNCT06578247
SponsorDaiichi Sankyo
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2030-06-26
Contact for this trial
Daiichi Sankyo Contact for Clinical Trial Information
. 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;