MedTrace Logo

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

NCT03250338 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2026-04-09

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Arog Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Eunice Wang, MD · Roswell Park Cancer Institute, Buffalo, New York, United States, 14263

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-16
Primary Completion
2026-04-03
Completion
2026-04-03
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Germany
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Drugs

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 NCT03250338 on ClinicalTrials.gov