for people ages 18-60 (full criteria)
at UC Davis UCLA
study started
completion around
Principal Investigator
by Caspian Oliai (ucla)



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.

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


Newly Diagnosed FLT3 Mutated AML, Cytarabine, Midostaurin, Crenolanib, Duanorubicin


You can join if…

Open to people ages 18-60

  • 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

You CAN'T join if...

  • 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)


  • Ronald Reagan UCLA Medical Center accepting new patients
    Los Angeles California 90095 United States
  • US Davis Health accepting new patients
    Sacramento California 95817 United States
  • City of Hope National Medical Center accepting new patients
    Duarte California 91010 United States

Lead Scientist at University of California Health

  • Caspian Oliai (ucla)
    HS Assistant Clinical Professor, Medicine. Authored (or co-authored) 24 research publications


accepting new patients
Start Date
Completion Date
Arog Pharmaceuticals, Inc.
Phase 3 research study
Study Type
Expecting 510 study participants
Last Updated