NCT07478991

Azacytidine, Venetoclax Plus Minus Quizartinib for First Line Older/Unfit AML Patients (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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 376 (estimated)
• Sponsor: PETHEMA Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Acute Myeloid Leukemia, Adult

Interventions

Type	Name	Description
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 .

Timeline

• Start date: 2026-03-01
• Primary completion: 2030-04-01
• Completion: 2030-04-01
• First posted: 2026-03-18
• Last updated: 2026-03-18

Locations

51 sites across 1 country: Spain