NCT03250338

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

Phase III Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of the Addition of Crenolanib to Salvage Chemotherapy Versus Salvage Chemotherapy Alone in Subjects ≤ 75 Years of Age With Relapsed/Refractory FLT3 Mutated Acute Myeloid Leukemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Arog Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations

Interventions

Type	Name	Description
DRUG	Crenolanib	Crenolanib will be administered orally
DRUG	Cytarabine	HAM regimen FLAG-Ida
DRUG	Mitoxantrone	HAM regimen
DRUG	Placebo Oral Tablet	Placebo will be administered orally
DRUG	Fludarabine	FLAG-Ida regimen
DRUG	Idarubicin	FLAG-Ida regimen
DRUG	G-CSF	FLAG-Ida regimen

Timeline

• Start date: 2018-08-16
• Primary completion: 2026-04-03
• Completion: 2026-04-03
• First posted: 2017-08-15
• Last updated: 2026-04-09

Locations

62 sites across 6 countries: United States, Canada, France, Germany, Italy, Spain

Regulatory

• FDA-regulated drug study