drugset / Trial / NCT06158100
Venetoclax in Combination With Azacitidine (VEN/AZA) Followed by Donor Lymphocyte Infusion (DLI) for Patients With Very High-Risk Acute Myeloid Leukemia (AML) Undergoing Allogeneic Hematopoietic Cell Transplant (HCT)
Non-randomizedSequentialOpen-labelTreatment
Summary
The purpose of this study is to see the effects of an investigational combination treatment of venetoclax, azacitidine, and donor lymphocyte infusion (DLI) in patients with high-risk AML receiving allogeneic hematopoietic cell transplantation, and to assess if the combination treatment is well tolerated and prevents disease relapse after transplant.
Timeline
- Start
- 2024-12-04
- Primary completion
- 2026-06-02
- Completion
- 2026-06-02
Outcome
Outcome not reported
Stopped (Business): “Funding Sponsor decision due to review of efficacy data from other trials involving investigational product.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | 20 mg/m2 | Subcutaneous |
| Subject | Venetoclax | Small molecule | 50 mg | Oral |
| Subject | Venetoclax | Small molecule | 100 mg | Oral |