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.
- Diseases
- Acute myeloid leukemia
- 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
Sites (31)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dana-Farber Cancer Insitute Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Beth Israel Deacnss Medical Center Oncology Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Roswell Park Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
| The UNC Lineberger Comprehensive Cancer Center Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| University of Virginia Health System Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| University of Illinois at Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Rush Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| University of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Karmanos Cancer Institute Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Henry Ford Health System Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| City of Hope National Medical Center Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| John Theurer Cancer Center At Hackensack UMC Coordinator of this site? Confirm its status | Hackensack | United States | Unknown status |
| Indiana University Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| University of Iowa Hospitals and Clinics Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| University of Kansas Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Ronald Reagan UCLA Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Rutgers Cancer Institute of New Jersey Coordinator of this site? Confirm its status | New Brunswick | United States | Unknown status |
| Yale Cancer Center Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| New York University Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Columbia University Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University of Rochester Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Cornell University Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Oregon Health and Science University Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| US Davis Health Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Montefiore Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| Wake Forest Baptist Health, Section on Hematology & Oncology Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.