Status:
UNKNOWN
Study Investigating the Efficacy of Crenolanib With Chemotherapy vs Chemotherapy Alone in R/R FLT3 Mutated AML
Lead Sponsor:
Arog Pharmaceuticals, Inc.
Conditions:
Relapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of AML according to World Health Organization (WHO) 2016 classification
- Presence of FLT3-ITD and/or D835 mutation(s)
- Subjects must be primary refractory or relapsed to 1st line intensive treatment for AML or refractory or relapsed after second line of treatment for AML
- Age ≥ 18 years and ≤ 75 years
- Adequate hepatic function
- Adequate renal functions
- ECOG performance status ≤ 3
Exclusion
- Known clinically active central nervous system(CNS) leukemia
- Severe liver disease
- Known, active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
- Prior anti-leukemia therapy within the 14 days prior to randomization. Prior use of quizartinib or gilteritinib must be discontinued 21 days prior to randomization. Prior use of hydroxyurea or other palliative treatment for leukocytosis is allowed.
- Previous treatment with crenolanib or prior participation in clinical trial involving crenolanib.
Key Trial Info
Start Date :
June 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
322 Patients enrolled
Trial Details
Trial ID
NCT03250338
Start Date
June 5 2018
End Date
October 1 2024
Last Update
April 30 2021
Active Locations (62)
Enter a location and click search to find clinical trials sorted by distance.
1
City of Hope National Medical Center
Sacramento, California, United States, 95817
2
UC Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
3
University of Florida
Gainesville, Florida, United States, 32610
4
University of Chicago
Chicago, Illinois, United States, 60637