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Acute Myeloid Leukemia, AdultPhase 3VENP-A-QUINCT07478991

Azacytidine, Venetoclax Plus Minus Quizartinib for First Line Older/Unfit AML Patients (VENP-A-QUI)

A Phase 3 study testing Azacitidine, Venetoclax and Quizartinib in people with Acute Myeloid Leukemia, Adult, run by PETHEMA Foundation at 52 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this clinical trial is to learn if Venetoclax+Azacytidine+Quizartinib works better than standard therapy (Venetoclax+Azacytdine) to treat naïve adult patients with acute myeloid leukemia (AML) who are not suitable for standard induction therapy due to age, co-morbidities or other risk factors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myeloid Leukemia, Adult
What is being tested?
Azacitidine, Venetoclax and Quizartinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
376 participants
Where
52 sitesSpain
Study dates
2 Jul 2026to Apr 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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.
Show all 15Show fewer
  • 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.
  • ECOG performance status ≤2 for patients >75 years, ≤3 for patients ≥ 60 to 75 years of age.
  • 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.
  • 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.
  • 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.

Who cannot join

  • Age <18 years old at screening.
  • Subject has received prior treatment with hypomethylating agent, FLT3 or BCL2 inhibitors.
  • 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.
  • Genetic diagnosis of acute promyelocytic leukemia.
  • 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.
  • 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.
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  • Serum creatinine ≥ 2.5 mg/dL or creatinine clearance < 30 mL/min.
  • Bilirubin >1.5 times, SGPT or SGOT > 3 times the upper normal limit (unless it is attributable to AML activity).
  • WBC >25 x 109/L before randomization.
  • Contraindications for Azacitidine, Quizartinib or Venetoclax (such as history of hypersensitivity to any excipients in Azacitidine, Quizartinib, or Venetoclax).
  • Known central nervous system (CNS) active leukemia, including cerebrospinal fluid positive for AML blasts.
  • 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.
  • Known uncontrolled or significant cardiovascular disease, including any of the following:
  • Bradycardia of less than 50 beats per minute, unless the subject has a pacemaker;
  • QTcF interval >450 msec;
  • Diagnosis of or suspicion of long QT syndrome (including family history of long QT syndrome);
  • Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg;
  • History of clinically relevant ventricular arrhythmias (eg, ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes);
  • 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);
  • History of uncontrolled angina pectoris or myocardial infarction within 6 months prior to Screening;
  • History of New York Heart Association Class 3 or 4 heart failure;
  • Known history of LVEF ≤45%;
  • Complete left bundle branch block;
  • Severe aortic stenosis
  • 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).
  • 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.
  • Active acute or chronic systemic fungal, bacterial, or viral infection not well controlled by antifungal, antibacterial or antiviral therapy at physician discretion.
  • Known active clinically relevant liver disease (eg, active hepatitis B, or active hepatitis C)
  • Known history of human immunodeficiency virus (HIV).
  • 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).
  • Uncontrolled hypothyroidism.

Trial locations and contacts

52 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Pau Montesinos contact

+3461244925

montesinos_pau@gva.es

Juan José Lahuerta contact

+34916266232

jjlahuerta@telefonica.net

52 sites in 1 country

Spain52 sites, 52 recruiting

  • Complejo Hospitalario de Albacete

    Albacete, 02006

    Jesús Lorenzo Algarra Algarra, jlalgarra@sescam.jccm.es

    Jesús Lorenzo Algarra Algarra

    Not yet recruiting

  • Hospital Principe de Asturias

    Alcalá de Henares, Madrid

    Julio García Suárez, jgsuarez@salud.madrid.org

    Julio García Suárez, Dr

    Recruiting

  • Hospital General Universitario Dr. Balmis

    Alicante

    Carmen Botella, Dr

    Not yet recruiting

  • Hospital Universitario Torrecárdenas

    Almería

    María José García, Dr

    Recruiting

  • Institut Catalá d´Oncología (ICO Badalona)

    Badalona

    Daniel Esteban

    Recruiting

  • Hospital Universitario de Cruces

    Barakaldo, Vizcaya, 48903

    Amaia Balerdi, amaia.balerdimalcorra@osakidetza.eus

    Amaia Balerdi

    Not yet recruiting

  • Hospital Galdakao-Usansolo

    Barakaldo

    Laida Cuevas

    Recruiting

  • Hospital Universitario de Basurto

    Barakaldo

    Miguel Quintana

    Recruiting

  • Hospital Universitario de Burgos

    Burgos

    Jorge Labrador, Dr

    Not yet recruiting

  • Complejo Hospitalario de Cáceres

    Cáceres

    Bergua Juan Miguel, Dr

    Bergua Juan Miguel, Dr

    Not yet recruiting

  • Hospital Universitario Puerta del Mar

    Cadiz

    Ana María Hoyos

    Recruiting

  • H. General de Castellón

    Castelló

    Raimundo García Boyero

    Not yet recruiting

  • Complejo Hospitalario Regional Reina Sofía

    Córdoba, 14004

    Josefina Serrano López, josefina.serrano@iname.com

    Juan Miguel Serra, datamanager1hurs@yahoo.com

    Not yet recruiting

  • Hospital Universitario Donostia

    Donostia / San Sebastian

    Esther Pérez Santaolalla

    Recruiting

  • ICO Hospitalet- Hospital Duran i Reynals

    Hospitalet Del Llobregat, Barcelona, 08908

    Cristina Marín, cmarin@iconcologia.net

    Montserrat Arnan, marnan@iconcologia.net

    Recruiting

  • Hospital Universitario Juan Ramón Jiménez

    Huelva, 21005

    María Solé Rodríguez, masrodriguez5983@gmail.com

    María Solé Rodríguez

    Not yet recruiting

  • Complejo Hospitalario de Jaén

    Jaén, Jaen, 23007

    Juan Antonio López, juan.antonio.lopez.hematologia@gmail.com

    Juan Antonio López

    Recruiting

  • Complejo Hospitalario de Gran Canaria Dr. Negrin

    Las Palmas de Gran Canaria

    Carlos Rodríguez Medina

    Carlos Rodríguez Medina

    Recruiting

  • Complejo Hospitalario Universitario Insular-Materno Infantil

    Las Palmas de Gran Canaria

    Susej Guedes

    Recruiting

  • Hospital Universitario de Canarias

    Las Palmas de Gran Canaria

    Carolina Lacalzada

    Recruiting

  • Hospital Universitario Lucus Augusti

    Lugo

    Aitor Abuín, Dr

    Not yet recruiting

  • Fundación Jiménez Díaz

    Madrid

    José Luis López Lorenzo

    Not yet recruiting

  • HLA Hospital Universitario Moncloa

    Madrid

    Sara Nistal

    Not yet recruiting

  • Hospital Clínico San Carlos

    Madrid

    Marta Polo Zarzuela

    Marta Polo Zarzuela

    Not yet recruiting

  • Hospital Infanta Leonor

    Madrid

    María Ángeles Foncillas, Dr

    Not yet recruiting

  • Hospital Univeristario Ramón y Cajal

    Madrid

    Pilar Herrera

    Not yet recruiting

  • Hospital Universitario HM Sanchinarro

    Madrid

    Felipe Casado

    Recruiting

  • HU Quirónsalud Madrid

    Madrid

    Carmen Martínez Chamorro

    Not yet recruiting

  • H.U. Puerta de Hierro Majadahonda

    Majadahonda

    Carlos de Miguel

    Not yet recruiting

  • Hospital Regional Universitario de Málaga

    Málaga, Malaga, 29010

    Beatriz Gago, beagc91@hotmail.es

    Alejandro Contento, dralejandrocontento@yahoo.com.ar

    Not yet recruiting

  • Hospital Universitario Virgen de la Victoria

    Málaga

    María García

    Recruiting

  • Althaia, Xarxa Asistencial de Manresa

    Manresa

    Jordi Vila, Dr

    Recruiting

  • Hospital Clinico Universitario Virgen de La Arrixaca

    Murcia

    Joaquin Antonio Gómez Espuch

    Joaquin Antonio Gómez Espuch

    Recruiting

  • Clínica Universitaria de Navarra

    Pamplona

    Ana Alfonso Piérola

    Ana Alfonso Piérola

    Not yet recruiting

  • Hospital Virgen Del Puerto

    Plasencia

    Rosa María López López

    Rosa María López López

    Not yet recruiting

  • Hospital Clínico Universitario de Salamanca.

    Salamanca

    Vidriales Belén, Dra

    Not yet recruiting

  • Hospital Universitario Infanta Sofía

    San Sebastián de los Reyes, Madrid, 28702

    Alicia Roldán Pérez, aroldanp@salud.madrid.org

    Lorena Pérez, lperez_ec@yahoo.es

    Not yet recruiting

  • Complejo Hospitalario Universitario Nuestra Señora de la Candelaria

    Santa Cruz de Tenerife, 38010

    Ana Yurena Oliva, anayoliva@gmail.com

    Ana Yurena Oliva

    Recruiting

  • H. Marqués de Valdecilla

    Santander

    Arancha Bermúdez

    Mercedes Colorado, MD

    Not yet recruiting

  • Complejo Hospitalario Universitario de A Coruña

    Santiago de Compostela, A Coruña, 15706

    Víctor Noriega Concepción, victor.noriega.concepcion@sergas.es

    Víctor Noriega Concepción

    Recruiting

  • Hospital de Santiago de Compostela

    Santiago de Compostela

    Pérez Encina manuel, Dr

    Not yet recruiting

  • Hospital General de Segovia

    Segovia

    Carmen Olivier Cornacha

    Carmen Olivier Cornacha

    Not yet recruiting

  • Hospital Universitario Virgen de Valme

    Seville

    María Vahí

    Not yet recruiting

  • Hospital Universitario Virgen Del Rocío

    Seville

    Eduardo Rodríguez Arbolí

    Eduardo Rodríguez Arbolí

    Not yet recruiting

  • Hospital Mútua de Terrassa

    Terrassa, Barcelona

    Ferran Vall-Llovera

    Recruiting

  • Hospital General Universitario de Toledo

    Toledo

    Jorge Cartier

    Recruiting

  • H. Dr. Peset

    Valencia

    María José Sayas

    María Pedreño, MD

    Recruiting

  • Hospital Arnau de Vilanova-Valencia

    Valencia

    Marta Valero

    Recruiting

  • Hospital General de Valencia

    Valencia

    Armando Mena-Duran, Dr

    Recruiting

  • Hospital Universitari i Politècnic La Fe

    Valencia

    Irene Navarro

    Not yet recruiting

  • H. Río Hortega

    Valladolid

    Alberto Cantalapiedra

    Recruiting

  • Hospital Álvaro Cunqueiro

    Vigo

    Paloma Picallo

    Not yet recruiting

Other trials in Spain

About this study

Official title: A Randomized Phase III, Global, Multicentre, Open Label Clinical Trial Comparing Venetoclax Azacytidine and Quizartinib Versus Venetoclax and Azacytidine in Newly Diagnosed Acute Myeloid Leukemia Patients Unelegible for Standard Induction Chemotherapy

The goal of this clinical trial is to learn if Venetoclax+Azacytidine+Quizartinib works better than standard therapy (Venetoclax+Azacytdine) to treat naïve adult patients with acute myeloid leukemia (AML) who are not suitable for standard induction therapy due to age, co-morbidities or other risk factors. The main question it aims to answer is:

  • Does the combination of Venetoclax+Azacytidine+Quizartinib show more probability of overall survival than Venetoclax+Azacytdine?
Read more

Researchers will compare Venetoclax+Azacytidine+Quizartinib to Venetoclax+Azacytdine to see if Venetoclax+Azacytidine+Quizartinib works better than Venetoclax+Azacytdine to treat AML.

Participants will be randomized to one of the two treatment arms in a 1:1 ratio, both of which will have treatment cycles of 28 days.

Read the detailed description

A total of 376 subjects will be randomized to meet scientific and regulatory objectives.

Experimental arm:

  • AZA 75 mg/m2 /daily SC, days 1 to 7 in 28-day cycle.
  • Venetoclax 400 mg/daily oral for 7 days, the same days as AZA.
  • Quizartinib 60 mg/daily oral in FLT3-ITD negative and 40 mg daily in FLT3-ITD positive patients, days 8 to 21.

Standard arm:

  • AZA 75 mg/m2 /daily SC, days 1 to 7 in 28-day cycle.
  • Venetoclax 400 mg/daily oral for 28 days.ç

Participants will continue their study treatment until documented disease progression, unacceptable toxicity, withdrawal of consent, or the participant meets other protocol criteria for discontinuation or study completion.

Survival information and post treatment follow up will be collected (via telephone calls and/or clinical visits) every 3 months after the last study visit for a period of 2 years after the last patient has been enrolled into the study.

Being tested
Azacitidine, Venetoclax, Quizartinib
Keywords
AML, adult, old/unfit
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AzacitidineDrug

    Subcutaneous injection during the first 7 days of each 28-day cycle until disease progression or end of study

  • VenetoclaxDrug

    Oral Venetoclax during the first 7 days of each 28-day cycle until disease progression or end of study

  • QuizartinibDrug

    Oral Quizartinib during days 8 to 21 of each 28-day cycle until disease progression or end of study .

Study groups in NCT07478991
Study groupRoleWhat they receive
Venetoclax Azacitidine and QuizartinibExperimental* Azacytidine 75 mg/m2 /daily SC, days 1 to 7 in 28-day cycle. * Venetoclax 400 mg/daily oral for days 1 to 7, the same days as Azacytidine, in 28-day-cycle. * Quizartinib 60 mg/daily oral in FLT3-ITD negative and 40 mg daily in FLT3-ITD positive patients, days 8 to 21.
Receives: Drug: Azacitidine; Drug: Venetoclax; Drug: Quizartinib
Venetoclax and AzacitidineActive comparator* Azacytidine 75 mg/m2 /daily SC, days 1 to 7 in 28-day cycle. * Venetoclax 400 mg/daily oral for days 1 to 7, the same days as Azacytidine, in 28-day-cycle.
Receives: Drug: Azacitidine; Drug: Venetoclax

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Comparison of time from diagnosis to death or last follow-up between both treatment arms.

    Measured: 4 years

Secondary outcomes (2)

  1. Event-free Survival rate

    To compare time from enrollment until the date of relapse from Complete Remission (CR), Complete Remission with hematologic recovery (CRh) or Complete Remission with incomplte hematologic recovery (CRi), failure to achieve CR, CRh, or CRi after 4 cycles after initiation of treatment, or death from any cause, between both treatment arms.

    Measured: 4 years

  2. Composite Complete Response (CCR) rate

    To evaluate the CCR (CR+CRh+CRi) of the study (best response obtained on study)

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2026
  2. Study start2 Jul 2026
  3. Primary completionApr 2030 (estimated)
  4. Study completionApr 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
376 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07478991
Sponsor's protocol ID
VENP-A-QUI
Acronym
VENP-A-QUI
Status last verified
Mar 2026
First submitted
13 Mar 2026
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Azacitidine, Venetoclax and Quizartinib in people with Acute Myeloid Leukemia, Adult, run by PETHEMA Foundation at 52 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pau Montesinos (+3461244925, montesinos_pau@gva.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07478991.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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