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

  • STATUS
    Recruiting
  • End date
    Nov 25, 2024
  • participants needed
    510
  • sponsor
    Arog Pharmaceuticals, Inc.
Updated on 25 January 2021

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.

Details
Condition Newly Diagnosed FLT3 Mutated AML
Treatment cytarabine, crenolanib, Midostaurin, Duanorubicin
Clinical Study IdentifierNCT03258931
SponsorArog Pharmaceuticals, Inc.
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

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)
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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