CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 356 enrolled
Drug / intervention
gilteritinib +1 moredrug
Likely dose
Not stated in 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/NCT02997202
NCT02997202Phase 3Completed
CompareCT.gov

A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Trial of the FLT3 Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/ITD AML

Astellas Pharma Global Development, Inc.·interventional·Posted Dec 19, 2016·Updated Jan 17, 2025

In Brief

A Phase 3 clinical trial evaluating gilteritinib and Placebo for Acute Myeloid Leukemia. Completed, enrolled 356 participants across 118 sites in 16 countries.

Detailed Summary

The purpose of this study was to compare relapse-free survival between participants with FLT3/ITD AML in first morphologic complete remission (CR1) who underwent hematopoietic stem cell transplant (HCT) and were randomized to receive gilteritinib or placebo beginning after the time of engraftment for a two year period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia
CountriesAustralia, Belgium, Canada, Denmark, France, Germany, Greece, Italy, Japan, New Zealand, Poland, South Korea, Spain, Taiwan, United Kingdom, United States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI), Blood and Marrow Transplant Clinical Trials Network

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 19, 2016
Enrollment StartAug 16, 2017
Primary CompletionJan 7, 2023
Study CompletionMay 9, 2023
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 9.5 years ago

Interventions

gilteritinibdrug

oral

Placebodrug

oral