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Venetoclax, Azacitidine and Liposomal Mitoxantrone for Newly Diagnosed AML
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Summary
This is a Phase I/II, 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 adult patients with newly diagnosed Acute Myeloid Leukemia (AML) who are eligible for intensive chemotherapy. The study plans to enroll 30 participants. Patients will receive VAM induction therapy, followed by three cycles of intermediate-dose cytarabine consolidation and 12 cycles of Venetoclax plus Azacitidine maintenance. Allogeneic hematopoietic stem cell transplantation is recommended for high-risk or MRD-positive patients in remission.
Official title: A Phase I/II, Single-Arm, Open-Label Study of Venetoclax, Azacitidine, and Liposomal Mitoxantrone (VAM) as Induction Therapy in Newly-diagnosed Adult Patients With Acute Myeloid Leukemia (AML)
Key Details
Gender
All
Age Range
14 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-03-01
Completion Date
2029-03-01
Last Updated
2026-03-24
Healthy Volunteers
No
Conditions
Interventions
Venetoclax
BCL-2 inhibitor. Oral. Induction: 100 mg day 1, 200 mg day 2, then 400 mg days 3-9 or 3-14. Maintenance: 400 mg days 1-7.
Azacitidine
Hypomethylating agent. 75 mg/m²/day IV/SC on days 1-7 of induction and maintenance cycles.
Liposomal Mitoxantrone
Liposomal topoisomerase II inhibitor. 24 mg/m² IV on day 1 of each induction cycle.
Cytarabine
Antimetabolite. Consolidation: 2 g/m² (age \<60) or 1 g/m² (age ≥60) q12h IV on days 1-3 for 3 cycles.
Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Recommended for high-risk or MRD+ patients after response.