CompletedPhase 3

Study of Crenolanib vs Midostaurin Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed FLT3 Mutated AML

United States214 participantsStarted 2018-08-15

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Event-free survival (EFS)

Timeframe: 5 years

Trial details

NCT IDNCT03258931

SponsorArog Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-04-06