Clinical Trial

Venetoclax, Azacitidine and Liposomal Mitoxantrone for Newly Diagnosed AML

Recruiting
View on ClinicalTrials.gov →
Summary
This is a single-arm, open-label clinical trial evaluating the safety and preliminary efficacy of a novel induction regimen combining Venetoclax, Azacitidine, and Liposomal Mitoxantrone (VAM) in patients with newly diagnosed Acute Myeloid Leukemia (AML) who are eligible for intensive chemotherapy. The study plans to enroll 27 participants. Patients will receive VAM induction therapy, followed by three cycles of intermediate-dose cytarabine consolidation. Allogeneic hematopoietic stem cell transplantation is recommended for high-risk or MRD-positive patients in remission.
Protocol Amendment History 4 changes
notable Primary completion pushed: 2026-07-01 -> 2026-10-30 2026-08-08
critical Recruitment opened 2026-06-10
critical Primary endpoint(s) modified 2026-06-10
notable Enrollment reduced: 30 -> 27 participants 2026-06-10
Trial Details
NCT Number NCT07490288
Lead Sponsor Institute of Hematology & Blood Diseases Hospital, China
Conditions AML
Enrollment 27 participants
Start Date 2026-05-08
Primary Completion 2026-10-30 (estimated)
Study Completion 2029-03-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-07