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

NCT05833438 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-05-01

No results posted yet for this study

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.

Conditions

  • Acute Myeloid Leukemia (AML)

Interventions

DRUG

VEN+AZA-5

Up to 6 cycles: Azacitidine (AZA) 75 mg/m2, d1-5 of each 28 day cycle (SC) in combination with Venetoclax (VEN): 400 mg daily (orally)

Sponsors & Collaborators

  • AbbVie

    collaborator INDUSTRY

  • University Hospital Leipzig, Hematology Diagnostics Laboratory

    collaborator UNKNOWN

  • University of Leipzig, Clinical Trial Centre (ZKS)

    collaborator UNKNOWN

  • University of Leipzig

    lead OTHER

Principal Investigators

  • Klaus Metzeler, Prof. Dr. · Universitätsklinikum Leipzig, Klinik und Poliklinik für Hämatologie, Zelltherapie und Hämostaseologie

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-17
Primary Completion
2025-11-16
Completion
2026-05-31

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05833438 on ClinicalTrials.gov