New triple therapy aims to boost survival in frail AML patients

NCT ID NCT07478991

Disease control Sponsor: PETHEMA Foundation Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 01, 2026 · Updated 10 times

Summary

This phase 3 trial will test whether adding the drug quizartinib to the standard two-drug combination (venetoclax and azacitidine) helps adults with newly diagnosed acute myeloid leukemia (AML) live longer. The study includes 376 people aged 18 and older who cannot receive intensive chemotherapy due to age or health problems. Participants will be randomly assigned to receive either the standard two drugs or the three-drug combination, and researchers will compare survival rates between the groups.

What this could mean

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

Active substance: Quizartinib (added to venetoclax and azacitidine)
What this could lead to: If successful, this could offer a more effective treatment option for older or frail adults with acute myeloid leukemia, potentially improving survival without needing intensive chemotherapy.
What could go wrong: This is an early-stage phase 3 trial that has not yet started recruiting. Adding a third drug may increase side effects, and it is not yet known if the combination will actually improve outcomes compared to the current standard.

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

About 376 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Apr 2030

An estimate. End dates often move.

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 years and older

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. The subject must have confirmation of AML by 2022 WHO criteria, previously untreated and be ineligible for treatment with a standard cytarabine and anthracycline based induction regimen due to age and/or comorbidities. 2. Patients must be considered ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to age or co-morbidities defined by the following criteria: * ≥ 75 years of age; * or ≥ 18 to 75 years of age with at least one of the following co-morbidities: * ECOG Performance Status of 2 or 3; * Cardiac history of cardiac heart failure (CHF) requiring treatment or left ventricular ejection fraction (LVEF) \>45% and ≤ 55% or chronic stable angina. * DLCO ≤ 65% or FEV1 ≤ 65% and/or significant history of chronic pulmonary obstructive; * Creatinine clearance ≥ 30 mL/min to \< 50 ml/min (see Appendix 7); * Moderate hepatic impairment with total bilirubin, SGPT or SGOT \> 1.5 to ≤ 3.0 × ULN; * Non active/controlled prior neoplastic disease; * Any other patient´s comorbidity or disease condition that the physician judges to be incompatible with intensive chemotherapy must be reviewed and approved by the Clinical Trial Coordinator before study enrollment (e.g, prior neoplastic disease, high-risk cytogenetics). All patients aged less than 60 years old must be reviewed and approved by Clinical Trial Coordinator before study enrollment. 3. ECOG performance status ≤2 for patients \>75 years, ≤3 for patients ≥ 60 to 75 years of age. 4. Male subjects who are sexually active, must agree, from Study Day 1 through at least 120 days after the last dose of study drug, to practice the protocol specified contraception. 5. Female subjects must be either postmenopausal for at least 1 year before screening OR permanently surgical sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy) or Women of Childbearing Potential (WOCBP) must agree to practice 1 highly effective method and 1 additional effective (barrier) method of contraception, at the same time, from the time of signing the informed consent through 7 months after the last dose of study drug (female and male condoms should not be used together), or Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \[e.g., calendar, ovulation, symptothermal, postovulation methods\] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception). Female subjects of childbearing potential must have negative results for pregnancy test performed and must not be lactating and breastfeeding. 6. Subject must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study specific procedures, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care. Exclusion Criteria: 1. Age \<18 years old at screening. 2. Subject has received prior treatment with hypomethylating agent, FLT3 or BCL2 inhibitors. 3. Confirmed diagnosis of prior myelodysplastic syndrome (MDS) or a myeloproliferative neoplasm (MPN) or MDS/MPNs including CMML, aCML, JMML and others. This exclusion criterion will not be applicable to patients with FLT3 or NPM1 mutations (as per technical sensitivity threshold of local and/or central laboratory), who can be enrolled. 4. Genetic diagnosis of acute promyelocytic leukemia. 5. Treated (excluding surgery or hormone-therapy) for another malignancy within 6 months before randomization or previously diagnosed with another malignancy and have any evidence of disease which may compromise the administration of investigational treatment schedule. 6. 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. 7. Serum creatinine ≥ 2.5 mg/dL or creatinine clearance \< 30 mL/min. 8. Bilirubin \>1.5 times, SGPT or SGOT \> 3 times the upper normal limit (unless it is attributable to AML activity). 9. WBC \>25 x 109/L before randomization. 10. Contraindications for Azacitidine, Quizartinib or Venetoclax (such as history of hypersensitivity to any excipients in Azacitidine, Quizartinib, or Venetoclax). 11. Known central nervous system (CNS) active leukemia, including cerebrospinal fluid positive for AML blasts. 12. Prior treatment with any investigational drug or device within 14 days prior to Randomization (within 2 weeks for investigational or approved immunotherapy) or currently participating in other investigational interventional procedures. 13. Known uncontrolled or significant cardiovascular disease, including any of the following: 1. Bradycardia of less than 50 beats per minute, unless the subject has a pacemaker; 2. QTcF interval \>450 msec; 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 (eg, ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes); 6. History of 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. History of uncontrolled angina pectoris or myocardial infarction within 6 months prior to Screening; 8. History of New York Heart Association Class 3 or 4 heart failure; 9. Known history of LVEF ≤45%; 10. Complete left bundle branch block; 11. Severe aortic stenosis 14. Prior therapy for AML (except hydroxyurea, or maximum 1 gram/sqm/day per 2 days of cytarabine allowed to control hyperleukocytosis during the screening period). 15. Subject must not have consumed grapefruit, grapefruit products, Seville oranges (including marmalade-containing Seville oranges), or star fruit within 3 days before anticipated first dose of Venetoclax and must consent not to consume through the last dose of Venetoclax. 16. Active acute or chronic systemic fungal, bacterial, or viral infection not well controlled by antifungal, antibacterial or antiviral therapy at physician discretion. 17. Known active clinically relevant liver disease (eg, active hepatitis B, or active hepatitis C) 18. Known history of human immunodeficiency virus (HIV). 19. Uncorrected Grade 3 or 4 hypokalemia, hypomagnesemia or hypocalcemia (Subjects with Grade 1 or 2 electrolyte abnormalities can be enrolled while electrolytes are being corrected). 20. Uncontrolled hypothyroidism.

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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, adult

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

51 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Clínica Universitaria de Navarra
NOT_YET_RECRUITING

Pamplona, Spain
Complejo Hospitalario Regional Reina Sofía
NOT_YET_RECRUITING

Córdoba, 14004, Spain
Complejo Hospitalario Universitario Insular-Materno Infantil
RECRUITING

Las Palmas de Gran Canaria, Spain
Complejo Hospitalario Universitario Nuestra Señora de la Candelaria
NOT_YET_RECRUITING

Santa Cruz de Tenerife, 38010, Spain
Complejo Hospitalario Universitario de A Coruña
RECRUITING

Santiago de Compostela, A Coruña, 15706, Spain
Complejo Hospitalario de Albacete
NOT_YET_RECRUITING

Albacete, 02006, Spain
Complejo Hospitalario de Cáceres
NOT_YET_RECRUITING

Cáceres, Spain
Complejo Hospitalario de Gran Canaria Dr. Negrin
RECRUITING

Las Palmas de Gran Canaria, Spain
Complejo Hospitalario de Jaén
RECRUITING

Jaén, Jaen, 23007, Spain
Fundación Jiménez Díaz
NOT_YET_RECRUITING

Madrid, Spain
H. Dr. Peset
NOT_YET_RECRUITING

Valencia, Spain
H. General de Castellón
NOT_YET_RECRUITING

Castelló, Spain
H. Marqués de Valdecilla
NOT_YET_RECRUITING

Santander, Spain
H. Río Hortega
RECRUITING

Valladolid, Spain
H.U. Puerta de Hierro Majadahonda
NOT_YET_RECRUITING

Majadahonda, Spain
HLA Hospital Universitario Moncloa
NOT_YET_RECRUITING

Madrid, Spain
HU Quirónsalud Madrid
NOT_YET_RECRUITING

Madrid, Spain
Hospital Arnau de Vilanova-Valencia
RECRUITING

Valencia, Spain
Hospital Clinico Universitario Virgen de La Arrixaca
RECRUITING

Murcia, Spain
Hospital Clínico San Carlos
NOT_YET_RECRUITING

Madrid, Spain
Hospital Clínico Universitario de Salamanca.
NOT_YET_RECRUITING

Salamanca, Spain
Hospital Galdakao-Usansolo
RECRUITING

Barakaldo, Spain
Hospital General Universitario Dr. Balmis
NOT_YET_RECRUITING

Alicante, Spain
Hospital General Universitario de Toledo
RECRUITING

Toledo, Spain
Hospital General de Segovia
NOT_YET_RECRUITING

Segovia, Spain
Hospital General de Valencia
RECRUITING

Valencia, Spain
Hospital Infanta Leonor
NOT_YET_RECRUITING

Madrid, Spain
Hospital Mútua de Terrassa
RECRUITING

Terrassa, Barcelona, Spain
Hospital Principe de Asturias
NOT_YET_RECRUITING

Alcalá de Henares, Madrid, Spain
Hospital Regional Universitario de Málaga
NOT_YET_RECRUITING

Málaga, Malaga, 29010, Spain
Hospital Univeristario Ramón y Cajal
NOT_YET_RECRUITING

Madrid, Spain
Hospital Universitari i Politècnic La Fe
NOT_YET_RECRUITING

Valencia, Spain
Hospital Universitario Donostia
NOT_YET_RECRUITING

Donostia / San Sebastian, Spain
Hospital Universitario HM Sanchinarro
RECRUITING

Madrid, Spain
Hospital Universitario Infanta Sofía
NOT_YET_RECRUITING

San Sebastián de los Reyes, Madrid, 28702, Spain
Hospital Universitario Juan Ramón Jiménez
NOT_YET_RECRUITING

Huelva, 21005, Spain
Hospital Universitario Lucus Augusti
NOT_YET_RECRUITING

Lugo, Spain
Hospital Universitario Puerta del Mar
NOT_YET_RECRUITING

Cadiz, Spain
Hospital Universitario Torrecárdenas
NOT_YET_RECRUITING

Almería, Spain
Hospital Universitario Virgen Del Rocío
NOT_YET_RECRUITING

Seville, Spain
Hospital Universitario Virgen de Valme
NOT_YET_RECRUITING

Seville, Spain
Hospital Universitario Virgen de la Victoria
RECRUITING

Málaga, Spain
Hospital Universitario de Basurto
NOT_YET_RECRUITING

Barakaldo, Spain
Hospital Universitario de Burgos
NOT_YET_RECRUITING

Burgos, Spain
Hospital Universitario de Canarias
RECRUITING

Las Palmas de Gran Canaria, Spain
Hospital Universitario de Cruces
NOT_YET_RECRUITING

Barakaldo, Vizcaya, 48903, Spain
Hospital Virgen Del Puerto
NOT_YET_RECRUITING

Plasencia, Spain
Hospital de Santiago de Compostela
NOT_YET_RECRUITING

Santiago de Compostela, Spain
Hospital Álvaro Cunqueiro
NOT_YET_RECRUITING

Vigo, Spain
ICO Hospitalet- Hospital Duran i Reynals
RECRUITING

Hospitalet Del Llobregat, Barcelona, 08908, Spain
Institut Catalá d´Oncología (ICO Badalona)
RECRUITING

Badalona, Spain

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