Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML) (QuANTUM-First)
Quizartinib is an experimental drug. It is not approved for regular use. It can only be used in medical research.
Adults might be able to join this study after bone marrow tests show they have a certain kind of blood cancer (FLT3-ITD AML).
Participants will have an equal chance of receiving quizartinib or placebo along with their chemotherapy
This is a phase 3, randomized, double-blind, placebo-control global study. The purpose of this study is to compare the effect of quizartinib versus placebo (administered with standard induction and consolidation chemotherapy, then administered as continuation therapy for up to 36 cycles) on event-free survival in subjects with FLT3-internal tandem duplication (ITD) positive AML.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 536 participants
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Double-Blind, Placebo-controlled Study of Quizartinib Administered in Combination With Induction and Consolidation Chemotherapy, and Administered as Continuation Therapy in Subjects 18 to 75 Years Old With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (QuANTUM First)
Actual Study Start Date: September 2016
Estimated Primary Completion Date: November 2020
Estimated Study Completion Date: November 2020
- Experimental: Chemotherapy plus quizartinib
- Active Comparator: Chemotherapy plus placebo
|Date last updated at source||2019-04-03|
|Study start date||2016-09-01|
|Estimated primary completion date||2020-11-01|