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New pill combo aims to improve AML treatment in Non-FLT3 patients

NCT ID NCT04107727

Disease control Sponsor: PETHEMA Foundation 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 2 trial tested whether adding the targeted drug quizartinib to standard chemotherapy helps adults with newly diagnosed acute myeloid leukemia (AML) that does not have a FLT3 mutation. 273 patients were randomly assigned to receive either quizartinib or a placebo alongside their chemo. The study looked at how long patients stayed free of leukemia-related events and how well they tolerated the treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Quizartinib (a targeted cancer drug taken as a pill)
What this could lead to
If successful, this could provide a new treatment option for people with a common type of AML that lacks the FLT3 mutation.
What could go wrong
This is a phase 2 trial, so results are still early. The drug may not improve outcomes or could cause side effects. It is also tested only in a specific genetic subgroup.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

273 people

The number who actually took part.

Started

Sep 2019

Finished

Jan 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 70 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. Written informed consent in accordance with national, local, and institutional guidelines. The patient must provide informed consent before the first screening procedure. The patient and the investigator must sign informed consent form. 2. Diagnosis of untreated AML (according to the World Health Organization (WHO) 2008/2016 definition) 3. Age ≥ 18 and ≤70 years old at the time of screening 4. Non-FLT3-ITD (allelic ratio \<0.03) at diagnosis 5. Considered eligible to receive intensive chemotherapy as per investigator judgment 6. Eastern Cooperative Oncology Group (ECOG) 0-2 7. No contraindications for quizartinib 8. The subject is receiving standard "7+3" induction chemotherapy regimen as specified in the protocol 9. No severe organ function abnormalities 10. Not included in other first-line trials 11. Cardiac ejection fraction ≥ 45% assessed by echocardiography or multiple-gated acquisition (MUGA). 12. Female patients of child-bearing potential must have a negative serum pregnancy test at screening and agree to use reliable methods of contraception upon enrollment, during the treatment period and for 3 months following the last dose of investigational drug or cytarabine, whichever is later 13. Male patients must use a reliable method of contraception (if sexually active with a female of child-bearing potential) upon enrollment, during the treatment period, and for 3 months following the last dose of investigational drug or cytarabine, whichever is later 14. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. Exclusion Criteria: 1. Patients with a genetic diagnosis of acute promyelocytic leukemia 2. Age \<18 years or \>70 years 3. ECOG performance status of 3 or 4 4. Prior treatment for AML, except for the following allowances: c) Leukapheresis d) Treatment for hyperleukocytosis with hydroxyurea 5. Blastic phase of bcr/abl chronic myeloid leukemia. 6. Presence of an associated active and/or uncontrolled malignancy: \- Patients with another neoplastic disease, for whom the Investigator has a clinical suspicion of active disease at the time of enrollment. Note: Patients with adequately treated early stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or cervical intraepithelial neoplasia are eligible for this study. Hormonal or adjuvant therapies will be allowed for breast cancer or prostate cancer as long as they are on a stable dose for at least 2 weeks before the first dose. 7. Known active and not controlled hepatitis B or hepatitis C infection. In the event of a positive viral load, please consult with the Sponsor 8. Known human immunodeficiency virus (HIV) infection (HIV testing is not required as part of this study) 9. Presence of any severe psychiatric disease or physical condition that, according to the physician´s criteria, contraindicates the inclusion of the patient into the clinical trial 10. Serum creatinine ≥ 250 μmol/l (≥ 2.5 mg/dL) (unless it is attributable to AML activity) 11. Bilirubin, alkaline phosphatase, or Serum glutamic oxaloacetic transaminase (SGOT) \> 3 times the normal upper limit (unless it is attributable to AML activity) 12. Uncontrolled or significant cardiovascular disease, including any of the following: 1. Symptomatic bradycardia of fewer than 50 beats per minute, unless the subject has a pacemaker; 2. QT Comparison of Fridericia's (QTcF) \>450 msec at Screening. Note: QTcF will be derived from the mean of triplicate readings; 3. Diagnosis of or suspicion of long QT syndrome (including family history of long QT syndrome); 4. Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥ 110 mmHg; 5. History of clinically relevant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes) 6. History of a second (Mobitz II) or third-degree heart block (subjects with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker) 7. An ejection fraction \<45% 8. History of uncontrolled angina pectoris or myocardial infarction within 6 months prior to Screening 9. History of New York Heart Association Class 3 or 4 heart failure 10. Right bundle branch and left anterior hemiblock (bifascicular block), complete left bundle branch block 13. History of hypersensitivity to any excipients in the quizartinib/placebo tablets 14. Females who are pregnant or breastfeeding 15. Any patients with known significant impairment in gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of quizartinib. 16. Active acute or chronic Graft-Versus-Host-Disease (GVHD) requiring prednisone \>10 mg or equivalent corticosteroid daily.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia

As listed by the trial registrant

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

Acute myeloid leukemia

Contacts and locations

Locations

  • Complejo Hospitalario Lucus Augusti

    Lugo, 27003, Spain

  • Complejo Hospitalario Regional Reina Sofía

    Córdoba, 14004, Spain

  • Complejo Hospitalario Regional Virgen del Rocío

    Seville, 41013, Spain

  • Complejo Hospitalario Universitario de A Coruña

    Santiago de Compostela, A Coruña, 15706, Spain

  • Complejo Hospitalario Universitario de Gran Canaria Dr. Negrín

    Las Palmas de Gran Canaria, Las Palmas, 35020, Spain

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela, A Coruña, 15706, Spain

  • Complejo Hospitalario Universitario de Vigo

    Vigo, Pontevedra, 36312, Spain

  • Complejo Hospitalario de Albacete

    Albacete, 02006, Spain

  • Complejo Hospitalario de Jaén

    Jaén, 23007, Spain

  • Complejo Hospitalario de Pontevedra

    Pontevedra, 36071, Spain

  • Complejo Hospitalario de Toledo

    Toledo, 45004, Spain

  • Complejo Universitario de Navarra

    Pamplona, 31008, Spain

  • Fundación Jiménez Díaz

    Madrid, 28040, Spain

  • Hospital Clínico San Carlos

    Madrid, Spain

  • Hospital Clínico Universitario Lozano Blesa

    Zaragoza, 50009, Spain

  • Hospital Clínico Universitario Valencia

    Valencia, 46010, Spain

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47003, Spain

  • Hospital General Universitario Santa Lucía

    Cartagena, Murcia, 30200, Spain

  • Hospital General Universitario de Alicante

    Alicante, 03010, Spain

  • Hospital General Univesitario de Castellón

    Castellon, Castellón, 12004, Spain

  • Hospital Juan Ramón Jiménez

    Huelva, 21005, Spain

  • Hospital La Paz

    Madrid, Spain

  • Hospital Nuestra Señora del Prado

    Talavera de la Reina, Spain

  • Hospital Puerta del Mar

    Cadiz, Spain

  • Hospital Ramón y Cajal

    Madrid, Spain

  • Hospital Regional Universitario Málaga

    Málaga, 29010, Spain

  • Hospital San Pedro de Alcántara

    Cáceres, 10003, Spain

  • Hospital Txagorritxu

    Vitoria-Gasteiz, Álava, 01009, Spain

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916, Spain

  • Hospital Universitari Vall Hebron

    Barcelona, 08035, Spain

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Central de Asturias

    Oviedo, 33006, Spain

  • Hospital Universitario Dr. Peset Aleixandre

    Valencia, 46017, Spain

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008, Spain

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009, Spain

  • Hospital Universitario Quirón Salud Madrid

    Pozuelo de Alarcón, Madrid, 28223, Spain

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010, Spain

  • Hospital Universitario Virgen de las Nieves

    Granada, 18014, Spain

  • Hospital Universitario de Basurto

    Bilbao, Vizcaya, 48013, Spain

  • Hospital Universitario de Burgos

    Burgos, 09006, Spain

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain

  • Hospital Universitario de Galdakao

    Galdakao, Vizcaya, 48960, Spain

  • Hospital Universitario de Salamanca

    Salamanca, 37007, Spain

  • Hospital Virgen de la Arrixaca

    Murcia, Spain

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