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).
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 cycles) on the primary endpoint of overall survival (OS) in adult patients with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) negative acute myeloid leukemia (AML). Participants will be tested for FLT3-ITD mutation status in a central laboratory using a validated assay.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
700
Participants will receive quizartinib at 60 mg/day orally once daily
Participants will receive placebo at 60 mg/day orally once daily
Participants will receive commercially available cytarabine (cytosine arabinoside) and anthracycline (daunorubicin or idarubicin).
Overall Survival (Arm A vs Arm B)
Overall survival (OS) is defined as the time from randomization until death from any cause.
Time frame: Date of first patient randomized to the target number of deaths reached, up to approximately 42 months
Event-free survival (Arm A vs. Arm B)
Event-free survival (EFS) is defined as time from randomization to date of failure to achieve CR at end of induction, relapse after CR, or death due to any cause, whichever occurs first
Time frame: Date of randomization up to approximately 42 months
Duration of complete response (Arm A vs. Arm B)
Duration of complete response (DoCR) is defined as time from the first documented CR until documented relapse or death due to any cause, whichever comes first. As assessed by Independent Review Committee.
Time frame: Date of randomization up to approximately 42 months
Relapse-free survival (Arm A vs. Arm B)
Relapse-free survival (RFS) is defined as time from randomization, for participants who achieve CR in the Induction Phase, until relapse or death due to any cause, whichever comes first. As assessed by Independent Review Committee .
Time frame: Date of randomization up to approximately 42 months
Complete remission rate (Arm A vs. Arm B)
Complete remission rate (CR) is defined as proportion of of participants who achieved a CR. As assessed by Independent Review Committee.
Time frame: At end of Induction Phase, up to approximately 120 days
Complete remission rate with minimal or measurable residual disease (Arm A vs. Arm B)
Proportion of participants achieving CR with minimal or measurable residual disease (MRD) negativity. As assessed by Independent Review Committee.
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City of Hope Phoenix
Goodyear, Arizona, United States
RECRUITINGMayo Clinic - Phoenix
Phoenix, Arizona, United States
RECRUITINGUniversity of Arizona Cancer Center
Tucson, Arizona, United States
RECRUITINGDavid Geffen School of Medicine
Los Angeles, California, United States
RECRUITINGUniversity of California Davis Health System
Sacramento, California, United States
RECRUITINGUcsf - School of Medicine
San Francisco, California, United States
RECRUITINGStanford University School of Medicine- Parent
Stanford, California, United States
RECRUITINGColorado Blood Cancer Institute
Denver, Colorado, United States
RECRUITINGYale University
New Haven, Connecticut, United States
RECRUITINGMayo Clinic Hospital
Jacksonville, Florida, United States
RECRUITING...and 282 more locations
Time frame: At end of Induction Phase (Cycle 2 or Cycles 1 and 2), up to approximately 120 days
Number of Participants With Treatment-emergent Adverse Events (Arm A vs. Arm B)
Treatment-emergent adverse events (TEAE) are defined as those AEs with start or worsening date during the on-treatment period (from the first dose date of quizartinib/placebo to 30 days after the last dose date of quizartinib/placebo).
Time frame: Date of first dose up to 30 days after last dose, up to approximately 42 months