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

NCT02039726 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 367

Last updated 2021-02-24

Study results available
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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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Jorge E. Cortes, MD · M.D. Anderson Cancer Center

  • Global Clinical Leader · Daiichi Sankyo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2018-02-22
Completion
2020-09-08

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Croatia
  • Czechia
  • France
  • Germany
  • Hong Kong
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • Serbia
  • Singapore
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02039726 on ClinicalTrials.gov