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New drug shows promise in leukemia battle

NCT ID NCT03258931

Disease control Sponsor: Arog Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug, crenolanib, against the standard drug midostaurin in adults with a specific genetic type of acute myeloid leukemia (FLT3-mutated AML). All 214 participants received standard chemotherapy and, if eligible, a bone marrow transplant, plus one of the two drugs. The goal was to see which drug better prevents the cancer from returning and helps people live longer.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

214 people

The number who actually took part.

Started

Aug 2018

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia, FLT3 internal tandem duplication

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Newly diagnosed FLT3 mutated AML

Contacts and locations

Locations

  • Beth Israel Deacnss Medical Center Oncology

    Boston, Massachusetts, 02215, United States

  • City of Hope National Medical Center

    Duarte, California, 91010, United States

  • Columbia University

    New York, New York, 10032, United States

  • Cornell University

    New York, New York, 10065, United States

  • Dana-Farber Cancer Insitute

    Boston, Massachusetts, 02215, United States

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Indiana University

    Indianapolis, Indiana, 46206-5149, United States

  • John Theurer Cancer Center at Hackensack UMC

    Hackensack, New Jersey, 07601, United States

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • Mount Sinai

    New York, New York, 10029-6574, United States

  • New York University

    New York, New York, 10016, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095, United States

  • Roswell Park

    Buffalo, New York, 14263, United States

  • Rush Medical Center

    Chicago, Illinois, 60612, United States

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901, United States

  • The UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27514, United States

  • US Davis Health

    Sacramento, California, 95817, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Illinois at Chicago

    Chicago, Illinois, 60612, United States

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242, United States

  • University of Kansas

    Kansas City, Kansas, 66160, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • University of Rochester Medical Center

    New York, New York, 14642, United States

  • University of Virginia Health System

    Charlottesville, Virginia, 22908, United States

  • Wake Forest Baptist Health, Section on Hematology & Oncology

    Winston-Salem, North Carolina, 27157, United States

  • Yale Cancer Center

    New Haven, Connecticut, 06510, United States