NCT07490288

Venetoclax, Azacitidine and Liposomal Mitoxantrone for Newly Diagnosed AML

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)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 14 Years – 100 Years
• Healthy volunteers: Not accepted

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. Allogeneic hematopoietic stem cell transplantation is recommended for high-risk or MRD-positive patients in remission.

Conditions

• AML

Interventions

Type	Name	Description
DRUG	Venetoclax	BCL-2 inhibitor. Oral. Induction: 100 mg day 1, 200 mg day 2, then 400 mg days 3-9 or 3-14.
DRUG	Azacitidine	Hypomethylating agent. 75 mg/m²/day IV/SC on days 1-7 of induction.
DRUG	Liposomal Mitoxantrone	Liposomal topoisomerase II inhibitor. 24 mg/m² IV on day 1 of each induction cycle.
DRUG	Cytarabine	Antimetabolite. Consolidation: 2 g/m² (age \<60) or 1 g/m² (age ≥60) q12h IV on days 1-3 for 3 cycles.
PROCEDURE	Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)	Recommended for high-risk or MRD+ patients after response.

Timeline

• Start date: 2026-04-30
• Primary completion: 2026-07-01
• Completion: 2029-03-01
• First posted: 2026-03-24
• Last updated: 2026-04-16