Venetoclax, Azacitidine and Liposomal Mitoxantrone for Newly Diagnosed AML
Condition(s) studied
Investigational drug(s) / intervention(s)
Venetoclax: BCL-2 inhibitor. Oral. Induction: 100 mg day 1, 200 mg day 2, then 400 mg days 3-14.
Azacitidine: Hypomethylating agent. 75 mg/m²/day IV/SC on days 1-7 of induction.
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.
Study 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.
Eligibility
Primary outcome measure(s)
- complete remission rate after induction — up to 84 days
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Blood diseases hospital | Tianjin | Tianjin Municipality | Recruiting |
On this site
📄 Venclexta (venetoclax) drug profile →More Institute of Hematology & Blood Diseases Hospital, China trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07490288 on ClinicalTrials.gov ↗ ← All trials in China