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

Recruiting
18 years - 60 years
All
Phase N/A
1 Location

Brief description of study

This is 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.

Detailed description of study

The purpose of this study is to compare the efficacy of crenolanib with midostaurin administered following induction chemotherapy and consolidation therapy on event-free survival (EFS) in newly diagnosed acute myeloid leukemia subjects with FLT3 mutation.
Participants will not be paid for their participation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Acute Myeloid Leukemia
  • Age: 18 years - 60 years
  • Gender: All

Inclusion Criteria
Confirmed diagnosis of de novo AML
Adequate hepatic function within 48 hours prior to induction chemotherapy
Adequate renal functions within 48 hours prior to induction chemotherapy
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)

Updated on 04 Aug 2024. Study ID: 1807273738 (ARO-021)

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