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Promising combo targets Leukemia's genetic weakness

NCT ID NCT03250338

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether adding the drug crenolanib to standard chemotherapy helps adults up to age 75 with a hard-to-treat form of acute myeloid leukemia (AML) that has a specific genetic change (FLT3 mutation). Participants received either crenolanib or a placebo alongside chemo, followed by more treatment or a stem cell transplant. The goal was to see if the combination improves survival and remission rates.

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

106 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 75 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: 1. Confirmed diagnosis of AML according to World Health Organization (WHO) 2016 classification 2. Presence of FLT3-ITD and/or D835 mutation(s) 3. Subjects must be primary refractory or relapsed to 1st line intensive treatment for AML or refractory or relapsed after second line of treatment for AML 4. Age ≥ 18 years and ≤ 75 years 5. Adequate hepatic function 6. Adequate renal functions 7. ECOG performance status ≤ 3 Exclusion Criteria: 1. Known clinically active central nervous system(CNS) leukemia 2. Severe liver disease 3. Known, active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) 4. Prior anti-leukemia therapy within the 14 days prior to randomization. Prior use of quizartinib or gilteritinib must be discontinued 21 days prior to randomization. Prior use of hydroxyurea or other palliative treatment for leukocytosis is allowed. 5. Previous treatment with crenolanib or prior participation in clinical trial involving crenolanib.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia, FLT3 internal tandem duplication Recurrence

As listed by the trial registrant

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

Relapsed/refractory acute myeloid leukemia with FLT3 activating mutations

Contacts and locations

Locations

  • A.O.U. Città della Salute e della Scienza di Torino

    Torino, 10126, Italy

  • AO Ordine Mauriziano di Torino

    Torino, 10128, Italy

  • AO Ospedali Riuniti Marche Nord

    Pesaro, 61122, Italy

  • AO Ospedali Riuniti Villa Sofia-Cervello

    Palermo, Italy

  • AOU Careggi

    Florence, 50134, Italy

  • AOU Federico II

    Naples, 80131, Italy

  • AOU Maggiore della Carità

    Novara, 28100, Italy

  • AOU Policlinico Sant'Orsola-Malpighi

    Bologna, 40138, Italy

  • ASST Spedali Civili di Brescia

    Brescia, 25123, Italy

  • AULSS n 8 Berica Ospedale San Bortolo

    Vicenza, 36100, Italy

  • Aorn Antonio Cardarelli

    Naples, 80131, Italy

  • CHU Grenoble Alpes

    Grenoble, 38043, France

  • CHU de Bordeaux

    Pessac, 33604, France

  • CHU de Nantes - Hôtel Dieu

    Nantes, 44093, France

  • CHU de Poitiers

    Poitiers, 86021, France

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69494, France

  • City of Hope National Medical Center

    Sacramento, California, 95817, United States

  • Complejo Hospitalario Universitario A Coruna

    A Coruña, 15006, Spain

  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma, 00168, Italy

  • Fundacion Jimenez Diaz

    Madrid, 28040, Spain

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Hospital 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Avicenne

    Bobigny, 93000, France

  • Hospital Center of Versailles (Le Chesnay)

    Le Chesnay, 78157, France

  • Hospital Claude Huriez - Chru Lille

    Lille, 59037, France

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007, Spain

  • Hospital Clinico Universitario de Santiago

    Santiago de Compostela, 15706, Spain

  • Hospital Gregorio Maranon Servicio de Hematologia y Hemoterapia

    Madrid, Spain

  • Hospital Ramon y Cajal

    Madrid, 28034, Spain

  • Hospital U. Marques de Valdecilla

    Santander, Cantabria, 39008, Spain

  • Hospital U. Virgen del Rocio

    Seville, Andalusia, 41013, Spain

  • Hospital Universitario Central de Asturias (HUCA)

    Oviedo, Principality of Asturias, 33011, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario de Donostia

    Donostia / San Sebastian, 20014, Spain

  • Hospital Universitario y Politecnico La Fe

    Valencia, 46026, Spain

  • Hôpital St Louis

    Paris, 75010, France

  • IRCCS Foundation Ca 'Granda Ospedale Maggiore Policlinico

    Milan, 20122, Italy

  • IRCCS San Raffaele Hospital

    Milan, 20132, Italy

  • IRST - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola, 47014, Italy

  • Institut Paoli-Calmettes

    Marseille, 13009, France

  • Institut Universitaire du Cancer Toulouse

    Toulouse, 31059, France

  • Istituto Europeo di Oncologia

    Milan, 20141, Italy

  • Kansas University

    Kansas City, Kansas, 666160, United States

  • Karmanos Cancer Center

    Detroit, Michigan, 48201, United States

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09116, Germany

  • Ospedale Santa Maria delle Croci di Ravenna

    Ravenna, 48121, Italy

  • Policlinico GB Rossi, University Hospital Verona

    Verona, 37134, Italy

  • Policlinico Tor Vergata

    Roma, RM, 00133, Italy

  • Reina Sofia University Hospital

    Córdoba, 14004, Spain

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263, United States

  • San Pedro de Alcantara Hospital

    Cáceres, 10003, Spain

  • Technische Universität Dresden

    Dresden, Germany

  • UC Davis Comprehensive Cancer Center

    Sacramento, California, 95817, United States

  • University Hospital Nice L'Archet

    Nice, 06200, France

  • University of Alberta

    Edmonton, Alberta, T6G 2R3, Canada

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Florida

    Gainesville, Florida, 32610, United States

  • Universitätsklinikum Essen (AöR)

    Essen, 45147, Germany

  • Universitätsklinikum Frankfurt

    Frankfurt, Germany

  • Universitätsklinikum Halle (Saale)

    Halle, Germany

  • Universitätsklinikum Münster

    Münster, 48149, Germany

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27104, United States

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Other studies related to the condition(s) this trial covers.