Clinical Trial

Venetoclax in Combination With 5 Days Azacitidine in Untreated AML Patients, Not Eligible for Standard Induction Therapy

Study acronym: VENAZA-5S
Active, Not Recruiting Phase 2
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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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2023-04-25; most recent amendment 2026-04-27.
Status change: Recruiting → Active, Not Recruiting 2026-04-27
Status change: Not Yet Recruiting → Recruiting 2023-05-30
Trial Details
NCT Number NCT05833438
Lead Sponsor University of Leipzig
Collaborators: AbbVie, University Hospital Leipzig, Hematology Diagnostics Laboratory, University of Leipzig, Clinical Trial Centre (ZKS)
Conditions Acute Myeloid Leukemia (AML)
Enrollment 45 participants
Start Date 2023-05-17
Primary Completion 2025-11-16 (estimated)
Study Completion 2026-05 (estimated)
Updated on ClinicalTrials.gov 2026-05-01