Phase III Study of Maintenance Therapy with Subcutaneous Cytarabine and Venetoclax in Adults 18 to 60 Years with Acute Myeloid Leukemia After Complete Remission

What this Trial Is About

Researchers are evaluating the effectiveness of maintenance therapy using subcutaneous cytarabine combined with venetoclax in patients with Acute Myeloid Leukemia AML who are fit and have achieved complete remission after intensive chemotherapy. The study focuses on disease-free survival in these patients, especially those awaiting bone marrow transplantation or when transplantation is delayed or canceled. This is a phase III, randomized, open-label interventional trial involving young, fit AML patients. Participants in one group will receive subcutaneous cytarabine at 20 mg on days 1 through 7, venetoclax at 100 mg on days 1 through 7, and voriconazole 200 mg twice daily on days 1 through 7, along with best supportive care for up to 12 cycles or until they undergo bone marrow transplantation. The comparison group will receive best supportive care only. This treatment is given as a bridge to bone marrow transplantation or as maintenance if transplantation is not performed. During the study, participants will be randomly assigned to one of the two groups. Researchers will monitor disease-free survival over 24 months as the primary outcome. Patients will be assessed regularly throughout the treatment cycles, with ongoing monitoring for safety and response until transplantation or completion of 12 cycles. The total participation duration varies depending on transplantation timing and treatment course.

Maintenance Venetoclax in AML Fit Patients