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
PETHEMA Foundation
376 participants
Jul 2, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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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 .
Locations(51)
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NCT07478991