CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 367 enrolled
Drug / intervention
Quizartinib +1 moredrug
Likely dose
Quizartinib 30 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02039726
NCT02039726Phase 3Completed
CompareCT.gov

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

Daiichi Sankyo·interventional·Posted Jan 20, 2014·Updated Feb 24, 2021

In Brief

A Phase 3 clinical trial evaluating Quizartinib and Salvage Chemotherapy for AML. Completed, enrolled 367 participants across 131 sites in 19 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAML
CountriesAustralia, Belgium, Canada, Croatia, Czechia, France, Germany, Hong Kong, Hungary, Italy, Netherlands, Poland, Serbia, Singapore, South Korea, Spain, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 20, 2014
Enrollment StartMay 1, 2014
Primary CompletionFeb 22, 2018
Study CompletionSep 8, 2020
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 12.5 years ago

Interventions

Quizartinibdrug

20 or 30 mg quizartinib tablets administered orally once daily

Salvage Chemotherapydrug

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