drugset / Trial / NCT05833438
Venetoclax in Combination With 5 Days Azacitidine in Untreated AML Patients, Not Eligible for Standard Induction Therapy
Phase 2
Active not recruiting
45 enrolled
University of Leipzig
AbbVie · collabUniversity Hospital Leipzig, Hematology Diagnostics Laboratory · collabUniversity of Leipzig, Clinical Trial Centre (ZKS) · collab
NaSingle-groupOpen-labelTreatment
Summary
Acute myeloid leukemia (AML): continuous oral Venetoclax (VEN) and 7 days of s.c. Azacitidine (AZA) per 28-day cycle = standard of care for intensive induction therapy ineligible AML patients in Germany The VENAZA-5S pilot trial: AZA administration reduced to 5 days within each cycle to improve tolerability and treatment adherence due to less neutropenic infections, less treatment interruptions and less hospitalizations.
Timeline
- Start
- 2023-05-17
- Primary completion
- 2025-11-16
- Completion
- 2026-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | 75 mg/m2 | Subcutaneous |
| Subject | Venetoclax | Small molecule | 400 mg | Oral |