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NCT03258931CompletedPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 9 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
214 (actual)
First submitted
21 Aug 2017
Start date
15 Aug 2018
Primary completion date
6 Apr 2026
Lead sponsor
Arog Pharmaceuticals, Inc.
NCT number
NCT03258931

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 214
  • From 15 Aug 2018 to the primary completion date, 6 Apr 2026
  • 31 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior systemic anti-cancer treatment (e.g. chemotherapy, tyrosine kinase inhibitors, immunotherapy, or investigational agents)(except for hydroxyurea and/or leukapheresis)

Other illness

  • 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)

Other

  • Acute promyelocytic leukemia (APL)
  • Known clinically active central nervous system (CNS) leukemia

Who the study is looking for

  • 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

Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (31)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Dana-Farber Cancer Insitute
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BostonUnited StatesUnknown status
Massachusetts General Hospital
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BostonUnited StatesUnknown status
Beth Israel Deacnss Medical Center Oncology
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BostonUnited StatesUnknown status
Roswell Park
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BuffaloUnited StatesUnknown status
The UNC Lineberger Comprehensive Cancer Center
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Chapel HillUnited StatesUnknown status
University of Virginia Health System
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CharlottesvilleUnited StatesUnknown status
University of Illinois at Chicago
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ChicagoUnited StatesUnknown status
Rush Medical Center
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ChicagoUnited StatesUnknown status
University of Chicago
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ChicagoUnited StatesUnknown status
Karmanos Cancer Institute
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DetroitUnited StatesUnknown status
Henry Ford Health System
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DetroitUnited StatesUnknown status
City of Hope National Medical Center
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DuarteUnited StatesUnknown status
John Theurer Cancer Center At Hackensack UMC
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HackensackUnited StatesUnknown status
Indiana University
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IndianapolisUnited StatesUnknown status
University of Iowa Hospitals and Clinics
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Iowa CityUnited StatesUnknown status
University of Kansas
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Kansas CityUnited StatesUnknown status
Ronald Reagan UCLA Medical Center
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Los AngelesUnited StatesUnknown status
University of Minnesota
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MinneapolisUnited StatesUnknown status
Rutgers Cancer Institute of New Jersey
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New BrunswickUnited StatesUnknown status
Yale Cancer Center
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New HavenUnited StatesUnknown status
New York University
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New YorkUnited StatesUnknown status
Mount Sinai
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New YorkUnited StatesUnknown status
Columbia University
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New YorkUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesUnknown status
University of Rochester Medical Center
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New YorkUnited StatesUnknown status
Cornell University
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New YorkUnited StatesUnknown status
Oregon Health and Science University
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PortlandUnited StatesUnknown status
US Davis Health
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SacramentoUnited StatesUnknown status
Moffitt Cancer Center
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TampaUnited StatesUnknown status
Montefiore Medical Center
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The BronxUnited StatesUnknown status
Wake Forest Baptist Health, Section on Hematology & Oncology
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Winston-SalemUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.