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.
Brief Title
Study of Crenolanib vs Midostaurin Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed FLT3 Mutated AML
Central Contacts
Central Contact Role
Contact
Central Contact Phone
214-593-0500
Central Contact Email
info@arogpharma.com
Completion Date
Completion Date Type
Estimated
Conditions
Newly Diagnosed FLT3 Mutated AML
Eligibility Criteria
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)
* 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)
Inclusion Criteria
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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
60 Years
Minimum Age
18 Years
NCT Id
NCT03258931
Org Class
Industry
Org Full Name
Arog Pharmaceuticals, Inc.
Org Study Id
ARO-021
Overall Status
Unknown status
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
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
Primary Outcomes
Outcome Measure
Event-free survival (EFS)
Outcome Time Frame
5 years
Secondary Outcomes
Outcome Time Frame
7 years
Outcome Measure
Overall Survival
Outcome Time Frame
5 years
Outcome Measure
Relapse free survival
Outcome Time Frame
5 years
Outcome Measure
Composite complete remission rate
Outcome Time Frame
5 years
Outcome Measure
Duration of response
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Maximum Age Number (converted to Years and rounded down)
60
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Aditi Shastri
Investigator Email
ASHASTRI@montefiore.org
Investigator Phone
718-920-4826