Venetoclax, Azacitidine and Liposomal Mitoxantrone for Newly Diagnosed AML

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT07490288
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
14 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    BCL-2 inhibitor. Oral. Induction: 100 mg day 1, 200 mg day 2, then 400 mg days 3-14.
  • Azacitidine — DRUG
    Hypomethylating agent. 75 mg/m²/day IV/SC on days 1-7 of induction.
  • Liposomal Mitoxantrone — DRUG
    Liposomal topoisomerase II inhibitor. 24 mg/m² IV on day 1 of each induction cycle.
  • Cytarabine — DRUG
    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) — PROCEDURE
    Recommended for high-risk or MRD+ patients after response.

Study Details

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.

Key Dates

Start date
May 8, 2026
Status verified
Jun 2026
Primary completion
Jul 1, 2026
Completion
Mar 1, 2029

Study Design

Enrollment
27 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: VAM Induction Regimen
    Single-arm study evaluating venetoclax, azacitidine, and liposomal mitoxantrone (VAM) as induction in newly diagnosed AML patients fit for intensive chemotherapy. Patients receive 1-2 cycles of VAM induction, followed by 3 cycles of intermediate-dose cytarabine consolidation. High-risk or MRD+ patients may proceed to allogeneic HSCT.

Primary Outcome Measure

complete remission rate after induction [ Time Frame: up to 84 days ]

Central Contacts

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