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

Last updated: April 17, 2017
Sponsor: Arog Pharmaceuticals, Inc.
Overall Status: Active - Not Recruiting

Phase

3

Condition

Leukemia

Treatment

N/A

Clinical Study ID

NCT03116477
ARO-013
  • Ages 18-75
  • All Genders

Study Summary

This is a multi-center, randomized, trial to evaluate the efficacy of adding crenolanib to salvage chemotherapy versus salvage chemotherapy alone in subjects with relapsed/refractory FLT3-mutant AML. Approximately 320 subjects will be randomized 1:1 to receive either salvage chemotherapy (HAM or FLAG-Ida) with crenolanib (treatment arm 1) or salvage chemotherapy (HAM or FLAG-Ida) alone (treatment arm 2).

Eligibility Criteria

Inclusion

Inclusion Criteria:

Exclusion

Exclusion Criteria:

Study Design

Total Participants: 320
Study Start date:
August 01, 2017
Estimated Completion Date:
August 31, 2020