Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
536

Summary

Conditions
  • Acute Myeloid Leukemia
  • Leukemia
Type
Interventional
Phase
Phase 3
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Investigator, Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 75 years
Gender
Both males and females

Description

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 overall ...

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 overall survival in subjects with FLT3-internal tandem duplication (ITD) positive AML.

Tracking Information

NCT #
NCT02668653
Collaborators
Not Provided
Investigators
Study Director: Global Clinical Leader Daiichi Sankyo, Inc.