Study of Crenolanib vs Midostaurin Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed FLT3 Mutated AML
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 2/17/2019 |
| Start Date: | August 15, 2018 |
| End Date: | November 2024 |
Phase III Randomized Study of Crenolanib Versus Midostaurin Administered Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed Subjects With FLT3 Mutated Acute Myeloid Leukemia
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 bone marrow transplantation in newly diagnosed AML subjects with FLT3
mutation. About 510 subjects will be randomized in a 1:1 ratio to receive either crenolanib
in addition to standard first line treatment of AML (chemotherapy and if eligible,
transplantation) (arm A) or midostaurin and standard treatment (arm B). Potentially eligible
subjects will be registered and tested for the presence of FLT3 mutation. Once the FLT3
mutation status is confirmed and additional eligibility is established, subject will be
randomized and enter into the treatment phase.
that of midostaurin when administered following induction chemotherapy, consolidation
chemotherapy and bone marrow transplantation in newly diagnosed AML subjects with FLT3
mutation. About 510 subjects will be randomized in a 1:1 ratio to receive either crenolanib
in addition to standard first line treatment of AML (chemotherapy and if eligible,
transplantation) (arm A) or midostaurin and standard treatment (arm B). Potentially eligible
subjects will be registered and tested for the presence of FLT3 mutation. Once the FLT3
mutation status is confirmed and additional eligibility is established, subject will be
randomized and enter into the treatment phase.
Inclusion Criteria:
- 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 Criteria:
- 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)
We found this trial at
18
sites
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University of Chicago One of the world's premier academic and research institutions, the University of...
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Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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1500 East Duarte Road
Duarte, California 91010
Duarte, California 91010
626-256-HOPE (4673)
Phone: 626-218-2405
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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1275 York Ave
New York, New York 10021
New York, New York 10021
(212) 639-2000
Phone: 212-639-2126
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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