drugset / Trial / NCT03250338

Study Investigating the Efficacy of Crenolanib With Chemotherapy vs Chemotherapy Alone in R/R FLT3 Mutated AML

NCT03250338

Phase 3 Completed 106 enrolled Arog Pharmaceuticals, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a randomized, multi-center, double-blind, placebo-controlled study designed to evaluate the efficacy of crenolanib administered following salvage chemotherapy, consolidation chemotherapy, post bone marrow transplantation and as maintenance in relapsed/refractory AML subjects with FLT3 activating mutation.

Timeline

Start
2018-08-16
Primary completion
2026-04-03
Completion
2026-04-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Crenolanib Small molecule Oral
Background Cytarabine Small molecule
Background Fludarabine Small molecule
Background G-CSF Unknown
Background Idarubicin Small molecule
Background Mitoxantrone Small molecule