Combination of Venetoclax and Azacitidine for Untreated AML Patients Not Eligible for Standard 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)
This study is testing a new treatment combining Venetoclax and a shorter version of Azacitidine for people with untreated acute myeloid leukemia who can't receive standard therapy, to see if it helps them feel better with fewer side effects.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Leipzig Academic / other |
| Drugs / interventions | Chimeric Antigen Receptor |
| Locations | 10 sites (Berlin and 9 other locations) |
| Trial ID | NCT05833438 on ClinicalTrials.gov |
What this trial studies
This pilot trial investigates the combination of continuous oral Venetoclax (VEN) and a modified 5-day regimen of subcutaneous Azacitidine (AZA) for patients with untreated acute myeloid leukemia (AML) who are ineligible for standard induction therapy. The aim is to reduce the hematological toxicity associated with the standard 7-day AZA regimen while maintaining efficacy. By decreasing the duration of AZA administration, the study seeks to improve patient tolerability, reduce hospitalizations, and enhance overall quality of life. This single-arm study will compare outcomes with a historical control group treated with the standard regimen.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of AML who are ineligible for standard induction therapy due to age or comorbidities.
Not a fit: Patients with prior treatment for AML or myelodysplastic syndrome, or those with specific favorable-risk karyotype abnormalities, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved tolerability and adherence to treatment for elderly or comorbid AML patients.
How similar studies have performed: Other studies have shown success with similar combinations of Venetoclax and Azacitidine, but this specific modification of treatment duration is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * 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 Key Exclusion Criteria: * 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 * History of myeloproliferative neoplasm (MPN) * Diagnosis of acute promyelocytic leukemia (APL) * Presence of favorable-risk karyotype abnormalities: t(15;17), t(8;21), inv(16) or t(16;16)
Where this trial is running
Berlin and 9 other locations
- Helios Klinikum Berlin-Buch Klinik für Hämatologie und Stammzelltransplantation — Berlin, Germany (Recruiting)
- Klinikum Chemnitz gGmbH Klinik für lnnere Medizin Ill — Chemnitz, Germany (Active_not_recruiting)
- Carl-Thiem-Klinikum Cottbus gGmbH — Cottbus, Germany (Recruiting)
- Universitatsklinikum Carl Gustav Carus Dresden an der TU Dresden Medizinische Klinik und Poliklinik 1 Bereich Hamatologie — Dresden, Germany (Active_not_recruiting)
- Universitätsklinikum Heidelberg, Innere Medizin V; Klinik für Hämatologie, Onkologie und Rheumatologie — Heidelberg, Germany (Active_not_recruiting)
- Universitätsklinikum Leipzig, Klinik und Poliklinik für Hämatologie, Zelltherapie und Hämostaseologie — Leipzig, Germany (Recruiting)
- Kliniken Maria Hilf GmbH, Klinik für Hämatologie, Onkologie und Gastroenterologie — Mönchengladbach, Germany (Active_not_recruiting)
- Rotkreuzklinikum München, III. Medizinische Abteilung — München, Germany (Recruiting)
- Klinikum rechts der lsar der TU München, Klinik und Poliklinik für lnnere Medizin Ill — München, Germany (Active_not_recruiting)
- Kliniken Sindelfingen,Medizinische Klinik I — Sindelfingen, Germany (Active_not_recruiting)
Study contacts
- Principal investigator: Klaus Metzeler, Prof. Dr. — Universitätsklinikum Leipzig, Klinik und Poliklinik für Hämatologie, Zelltherapie und Hämostaseologie
- Study coordinator: Klaus Metzeler, Prof. Dr.
- Email: Klaus.Metzeler@medizin.uni-leipzig.de
- Phone: +49 341 97-13050
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.