Newly Diagnosed FLT3 Mutated AML
Conditions
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 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.
Interventions
DRUGCrenolanib
Crenolanib will be administered orally
DRUGMidostaurin
Midostaurin will be administered orally
DRUGCytarabine
100 mg/m² IV continuous infusion over 24 hours
DRUGDuanorubicin
90 mg/m2 IV
Sponsors
Arog Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-free survival (EFS) | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival | 7 years |
| Relapse free survival | 5 years |
| Composite complete remission rate | 5 years |
| Duration of response | 5 years |
Countries
United States
Outcome results
None listed