Study Comparing Venetoclax with Azacitidine and Quizartinib Versus Venetoclax with Azacitidine in Adult Patients with Newly Diagnosed Acute Myeloid Leukemia Who Cannot Receive Standard Induction Therapy

What this Trial Is About

Researchers are evaluating if a combination of Venetoclax, Azacytidine, and Quizartinib works better than the standard treatment of Venetoclax and Azacytidine to treat adult patients with newly diagnosed acute myeloid leukemia AML who cannot receive standard induction therapy due to age, other health issues, or risk factors. The study aims to determine which treatment offers a better chance of overall survival. Participants will be randomly assigned to one of two treatment groups. One group will receive Azacytidine by subcutaneous injection daily for seven days in each 28-day cycle, Venetoclax orally for seven days alongside Azacytidine, and Quizartinib orally from days 8 to 21, with doses adjusted based on genetic markers. The other group will receive Azacytidine injections for seven days and Venetoclax orally for seven days per cycle without Quizartinib. Treatments continue until disease progression, unacceptable side effects, or other criteria for stopping are met. During the study, participants will have regular visits for treatment and monitoring. Researchers will collect survival information and follow up by phone or clinic visits every three months for two years after the last patient enrolls. The main outcome measured is overall survival over four years. Additional outcomes include event-free survival and complete response rates over four years. Safety and health assessments will be regularly conducted throughout the trial.

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