Overview

(QuANTUM-R): An Open-label Study of Quizartinib Monotherapy vs. Salvage Chemotherapy in Acute Myeloid Leukemia (AML) Subjects Who Are FLT3-ITD Positive

Status:
Completed

Trial end date:
2020-09-08

Target enrollment:

Participant gender:

Summary

The primary objective of the study is to determine whether quizartinib monotherapy prolongs overall survival (OS) compared to salvage chemotherapy in subjects with FMS-like tyrosine kinase 3 - Internal Tandem Duplication (FLT3-ITD) positive AML who are refractory to or have relapsed within 6 months, after first-line AML therapy.

Phase:

Phase 3

Details

Lead Sponsor:

Daiichi Sankyo Inc.
Daiichi Sankyo, Inc.

Treatments:

Cytarabine
Etoposide
Idarubicin
Lenograstim
Mitoxantrone