Study of Crenolanib vs Midostaurin Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed FLT3 Mutated AML
Public ClinicalTrials.gov record NCT03258931. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03258931
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 214 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 60 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 15, 2018 (Actual)
- Primary completion
- Apr 6, 2026 (Actual)
- Completion
- Apr 6, 2026 (Actual)
- Last update posted
- Apr 9, 2026
2018 – 2026
United States locations
- U.S. sites
- 31
- U.S. states
- 15
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | 91010 | — |
| Ronald Reagan UCLA Medical Center | Los Angeles | California | 90095 | — |
| US Davis Health | Sacramento | California | 95817 | — |
| Yale Cancer Center | New Haven | Connecticut | 06510 | — |
| Moffitt Cancer Center | Tampa | Florida | 33612 | — |
| Rush Medical Center | Chicago | Illinois | 60612 | — |
| University of Illinois at Chicago | Chicago | Illinois | 60612 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Indiana University | Indianapolis | Indiana | 46206-5149 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| University of Kansas | Kansas City | Kansas | 66160 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Beth Israel Deacnss Medical Center Oncology | Boston | Massachusetts | 02215 | — |
| Dana-Farber Cancer Insitute | Boston | Massachusetts | 02215 | — |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| John Theurer Cancer Center at Hackensack UMC | Hackensack | New Jersey | 07601 | — |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | — |
| Roswell Park | Buffalo | New York | 14263 | — |
| New York University | New York | New York | 10016 | — |
| Mount Sinai | New York | New York | 10029-6574 | — |
| Columbia University | New York | New York | 10032 | — |
| Cornell University | New York | New York | 10065 | — |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | — |
| University of Rochester Medical Center | New York | New York | 14642 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| The UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27514 | — |
| Wake Forest Baptist Health, Section on Hematology & Oncology | Winston-Salem | North Carolina | 27157 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03258931, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 9, 2026 · Synced Nov 6, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03258931 live on ClinicalTrials.gov.