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

Sponsor
PETHEMA Foundation
Study ID
NCT07478991
Phase
PHASE3
Status
Recruiting
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Conditions

  • Acute Myeloid Leukemia, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Azacitidine — DRUG
    Subcutaneous injection during the first 7 days of each 28-day cycle until disease progression or end of study
  • Venetoclax — DRUG
    Oral Venetoclax during the first 7 days of each 28-day cycle until disease progression or end of study
  • Quizartinib — DRUG
    Oral Quizartinib during days 8 to 21 of each 28-day cycle until disease progression or end of study .

Study Details

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.

Key Dates

First listed
Mar 18, 2026
Start date
Jul 2, 2026
Status verified
Mar 2026
Primary completion
Apr 30, 2030
Completion
Apr 30, 2030

Study Design

Enrollment
376 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Venetoclax Azacitidine and Quizartinib
    * 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.
  • Active Comparator: Venetoclax and Azacitidine
    * 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.

Primary Outcome Measure

Overall Survival [ Time Frame: 4 years ]

Central Contacts

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