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NOT YET RECRUITING
NCT07490288
NA

Venetoclax, Azacitidine and Liposomal Mitoxantrone for Newly Diagnosed AML

Sponsor: Institute of Hematology & Blood Diseases Hospital, China

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

Azacitidine

Hypomethylating agent. 75 mg/m²/day IV/SC on days 1-7 of induction and maintenance cycles.

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.