NCT02039726

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

A Phase 3 Open-label Randomized Study of Quizartinib (AC220) Monotherapy Versus Salvage Chemotherapy in Subjects With Tyrosine Kinase 3 - Internal Tandem Duplication (FLT3-ITD) Positive Acute Myeloid Leukemia (AML) Refractory to or Relapsed After First-line Treatment With or Without Hematopoietic Stem Cell Transplantation (HSCT) Consolidation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 367 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• AML

Interventions

Type	Name	Description
DRUG	Quizartinib	20 or 30 mg quizartinib tablets administered orally once daily
DRUG	Salvage Chemotherapy	Low dose cytarabine (LoDAC); mitoxantrone, etoposide, and intermediate-dose cytarabine (MEC); or fludarabine, cytarabine, and granulocyte colony stimulating factor (G-CSF) with idarubicin (FLAG-IDA) administered during 28-day cycles

Timeline

• Start date: 2014-05-01
• Primary completion: 2018-02-22
• Completion: 2020-09-08
• First posted: 2014-01-20
• Last updated: 2021-02-24
• Results posted: 2020-01-27

Locations

131 sites across 19 countries: United States, Australia, Belgium, Canada, Croatia, Czechia, France, Germany, Hong Kong, Hungary, Italy, Netherlands, Poland, Serbia, Singapore, South Korea, Spain, Taiwan, United Kingdom