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

Investigational Medication for Acute Myeloid Leukemia with FLT3 Mutation

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 19 Feb 2024. Study ID: 1807273738 (ARO-021)

This study investigates the treatment of acute myeloid leukemia (AML) in patients with a specific genetic change called FLT3 mutation. The purpose is to compare two investigational medications given after initial and follow-up chemotherapy, as well as after bone marrow transplant, to see which is more effective in extending the time patients remain free of cancer events.

Participants will receive either one of the two investigational medications after their chemotherapy sessions. The study involves monitoring the patients' health and response to the medication to evaluate its effectiveness and safety.

  • Who can participate: Adults diagnosed with de novo acute myeloid leukemia (AML) with a FLT3 mutation can participate. Participants must have adequate liver and kidney function before starting chemotherapy.
  • Study details: Participants will receive one of the investigational medications after chemotherapy sessions. A placebo is not used in this study.

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