Status:
UNKNOWN
Study of Crenolanib vs Midostaurin Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed FLT3 Mutated AML
Lead Sponsor:
Arog Pharmaceuticals, Inc.
Conditions:
Newly Diagnosed FLT3 Mutated AML
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
A phase III randomized multi-center study designed to compare the efficacy of crenolanib with that of midostaurin when administered following induction chemotherapy, consolidation chemotherapy and bon...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of de novo AML according to World Health Organization (WHO) 2016 classification
- Presence of FLT3-ITD and/or D835 mutation(s) in bone marrow or peripheral blood
- Age ≥ 18 years and ≤ 60 years
- Adequate hepatic function within 48 hours prior to induction chemotherapy
- Adequate renal functions within 48 hours prior to induction chemotherapy
- ECOG performance status within 48 hours prior to induction chemotherapy ≤ 3
- Eligible for intensive cytarabine/daunorubicin (7+3) chemotherapy specified
Exclusion
- Acute promyelocytic leukemia (APL)
- Known clinically active central nervous system (CNS) leukemia
- Severe liver disease
- Active infections
- Known, active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
- Known infection with human immunodeficiency virus (HIV)
- Prior systemic anti-cancer treatment (e.g. chemotherapy, tyrosine kinase inhibitors, immunotherapy, or investigational agents)(except for hydroxyurea and/or leukapheresis)
Key Trial Info
Start Date :
August 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2024
Estimated Enrollment :
510 Patients enrolled
Trial Details
Trial ID
NCT03258931
Start Date
August 15 2018
End Date
November 1 2024
Last Update
May 22 2020
Active Locations (31)
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1
City of Hope National Medical Center
Duarte, California, United States, 91010
2
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
3
US Davis Health
Sacramento, California, United States, 95817
4
Yale Cancer Center
New Haven, Connecticut, United States, 06510