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

NCT07478991 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 376

Last updated 2026-03-18

No results posted yet for this study

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.

Conditions

  • Acute Myeloid Leukemia, Adult

Interventions

DRUG

Azacitidine

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

DRUG

Venetoclax

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

DRUG

Quizartinib

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

Sponsors & Collaborators

  • PETHEMA Foundation

    lead OTHER

Principal Investigators

  • Claudia Sossa · Clínica FOSCAL

  • Joana Brioso · Centro Hospitalar Universitário Lisboa Norte Hospital de Santa Maria

  • Juan Bergua · Hospital San Pedro Alcántara

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2030-04-30
Completion
2030-04-30

Countries

  • Spain

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07478991 on ClinicalTrials.gov