Azacytidine, Venetoclax Plus Minus Quizartinib for First Line Older/Unfit AML Patients (VENP-A-QUI)
VENP-A-QUI
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
1 other identifier
interventional
376
1 country
51
Brief 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. The main question it aims to answer is: \- Does the combination of Venetoclax+Azacytidine+Quizartinib show more probability of overall survival than Venetoclax+Azacytdine? 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2026
Typical duration for phase_3
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2026
CompletedFirst Posted
Study publicly available on registry
March 18, 2026
CompletedStudy Start
First participant enrolled
July 2, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2030
August 3, 2026
March 1, 2026
3.8 years
March 13, 2026
July 31, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival
Comparison of time from diagnosis to death or last follow-up between both treatment arms.
4 years
Secondary Outcomes (2)
Event-free Survival rate
4 years
Composite Complete Response (CCR) rate
4 years
Study Arms (2)
Venetoclax Azacitidine and Quizartinib
EXPERIMENTAL* 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.
Venetoclax and Azacitidine
ACTIVE 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.
Interventions
Subcutaneous injection during the first 7 days of each 28-day cycle until disease progression or end of study
Oral Venetoclax during the first 7 days of each 28-day cycle until disease progression or end of study
Oral Quizartinib during days 8 to 21 of each 28-day cycle until disease progression or end of study .
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- Age \<18 years old at screening.
- Subject has received prior treatment with hypomethylating agent, FLT3 or BCL2 inhibitors.
- 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.
- 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;
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
Complejo Hospitalario Universitario de A Coruña
Santiago de Compostela, A Coruña, 15706, Spain
ICO Hospitalet- Hospital Duran i Reynals
Hospitalet Del Llobregat, Barcelona, 08908, Spain
Hospital Mútua de Terrassa
Terrassa, Barcelona, Spain
Complejo Hospitalario de Jaén
Jaén, Jaen, 23007, Spain
Hospital Principe de Asturias
Alcalá de Henares, Madrid, Spain
Hospital Universitario Infanta Sofía
San Sebastián de los Reyes, Madrid, 28702, Spain
Hospital Regional Universitario de Málaga
Málaga, Malaga, 29010, Spain
Hospital Universitario de Cruces
Barakaldo, Vizcaya, 48903, Spain
Complejo Hospitalario de Albacete
Albacete, 02006, Spain
Hospital General Universitario Dr. Balmis
Alicante, Spain
Hospital Universitario Torrecárdenas
Almería, Spain
Institut Catalá d´Oncología (ICO Badalona)
Badalona, Spain
Hospital Galdakao-Usansolo
Barakaldo, Spain
Hospital Universitario de Basurto
Barakaldo, Spain
Hospital Universitario de Burgos
Burgos, Spain
Hospital Universitario Puerta del Mar
Cadiz, Spain
H. General de Castellón
Castelló, Spain
Complejo Hospitalario de Cáceres
Cáceres, Spain
Complejo Hospitalario Regional Reina Sofía
Córdoba, 14004, Spain
Hospital Universitario Donostia
Donostia / San Sebastian, Spain
Hospital Universitario Juan Ramón Jiménez
Huelva, 21005, Spain
Complejo Hospitalario de Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria, Spain
Complejo Hospitalario Universitario Insular-Materno Infantil
Las Palmas de Gran Canaria, Spain
Hospital Universitario de Canarias
Las Palmas de Gran Canaria, Spain
Hospital Universitario Lucus Augusti
Lugo, Spain
Fundación Jiménez Díaz
Madrid, Spain
HLA Hospital Universitario Moncloa
Madrid, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Infanta Leonor
Madrid, Spain
Hospital Univeristario Ramón y Cajal
Madrid, Spain
Hospital Universitario HM Sanchinarro
Madrid, Spain
HU Quirónsalud Madrid
Madrid, Spain
H.U. Puerta de Hierro Majadahonda
Majadahonda, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Hospital Clinico Universitario Virgen de La Arrixaca
Murcia, Spain
Clínica Universitaria de Navarra
Pamplona, Spain
Hospital Virgen Del Puerto
Plasencia, Spain
Hospital Clínico Universitario de Salamanca.
Salamanca, Spain
Complejo Hospitalario Universitario Nuestra Señora de la Candelaria
Santa Cruz de Tenerife, 38010, Spain
H. Marqués de Valdecilla
Santander, Spain
Hospital de Santiago de Compostela
Santiago de Compostela, Spain
Hospital General de Segovia
Segovia, Spain
Hospital Universitario Virgen de Valme
Seville, Spain
Hospital Universitario Virgen Del Rocío
Seville, Spain
Hospital General Universitario de Toledo
Toledo, Spain
H. Dr. Peset
Valencia, Spain
Hospital Arnau de Vilanova-Valencia
Valencia, Spain
Hospital General de Valencia
Valencia, Spain
Hospital Universitari i Politècnic La Fe
Valencia, Spain
H. Río Hortega
Valladolid, Spain
Hospital Álvaro Cunqueiro
Vigo, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claudia Sossa
Clínica FOSCAL
- PRINCIPAL INVESTIGATOR
Joana Brioso
Centro Hospitalar Universitário Lisboa Norte Hospital de Santa Maria
- PRINCIPAL INVESTIGATOR
Juan Bergua
Hospital San Pedro Alcántara
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2026
First Posted
March 18, 2026
Study Start
July 2, 2026
Primary Completion (Estimated)
April 1, 2030
Study Completion (Estimated)
April 1, 2030
Last Updated
August 3, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share