drugset / Trial / NCT07490288
Venetoclax, Azacitidine and Liposomal Mitoxantrone for Newly Diagnosed AML
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2026-05-08
- Primary completion
- 2026-07-01
- Completion
- 2029-03-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | 75 mg/m2 | Intravenous |
| Subject | Mitoxantrone | Small molecule | 24 mg/m2 | Intravenous |
| Subject | Venetoclax | Small molecule | 400 mg | Oral |
| Background | Cytarabine | Small molecule | 1 g | Intravenous |
| Background | Cytarabine | Small molecule | 2 g | Intravenous |