NCT05833438Active, not recruitingPhase 2
Venetoclax in Combination With 5 Days Azacitidine in Untreated AML Patients, Not Eligible for Standard Induction Therapy
A Single-arm, Pilot Study of Venetoclax in Combination With 5 Days Azacitidine in Treatment-naïve Subjects With Acute Myelogenous Leukemia Who Are ≥18 Years of Age and Not Eligible for Standard Induction Therapy (VENAZA-5S PILOT TRIAL)
Source: ClinicalTrials.gov · Last updated 1 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- First submitted
- 4 Mar 2023
- Start date
- 17 May 2023
- Primary completion date
- 16 Nov 2025
- Lead sponsor
- University of Leipzig
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT05833438
- EU CT number
- 2022-501537-23-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 45
- From 17 May 2023 to the primary completion date, 16 Nov 2025
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment for AML or myelodysplastic syndrome (MDS) with one of the following:
- Hypomethylating agent (HMA)
- Chemotherapeutic agent
- Chimeric Antigen Receptor (CAR)-T cell therapy
- Experimental therapies
- Note: Prior use of hydroxyurea is allowed
Other illness
- History of myeloproliferative neoplasm (MPN)
Other
- Diagnosis of acute promyelocytic leukemia (APL)
- Presence of favorable-risk karyotype abnormalities: t(15;17), t(8;21), inv(16) or t(16;16)
Who the study is looking for
- Confirmed diagnosis of AML by World Health Organization (WHO) criteria 2016
- Ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to age or comorbidities
- Age ≥ 18 years
- Life expectancy of at least 12 weeks
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Klinikum Chemnitz gGmbH Coordinator of this site? Confirm its status | Chemnitz | Germany | Completed |
| Carl Thiem Klinikum gGmbH Coordinator of this site? Confirm its status | Cottbus | Germany | Completed |
| Technische Universität Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Completed |
| Gemeinschaftspraxis Haematologie Onkologie Coordinator of this site? Confirm its status | Dresden | Germany | Completed |
| Heidelberg University Hospital AöR Coordinator of this site? Confirm its status | Heidelberg | Germany | Completed |
| University of Leipzig Coordinator of this site? Confirm its status | Leipzig | Germany | Completed |
| Kliniken Maria Hilf GmbH Coordinator of this site? Confirm its status | Mönchengladbach | Germany | Completed |
| Rotkreuzklinikum München gGmbH Coordinator of this site? Confirm its status | München | Germany | Completed |
| Klinikum rechts der Isar der TU Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Completed |
| Klinikverbund Suedwest GmbH Coordinator of this site? Confirm its status | Sindelfingen | Germany | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.