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)
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Germany
Helios Klinikum Berlin-Buch Klinik für Hämatologie und Stammzelltransplantation
RECRUITING
Berlin
Klinikum Chemnitz gGmbH Klinik für lnnere Medizin Ill
ACTIVE_NOT_RECRUITING
Chemnitz
Carl-Thiem-Klinikum Cottbus gGmbH
RECRUITING
Cottbus
Universitatsklinikum Carl Gustav Carus Dresden an der TU Dresden Medizinische Klinik und Poliklinik 1 Bereich Hamatologie
ACTIVE_NOT_RECRUITING
Dresden
Universitätsklinikum Heidelberg, Innere Medizin V; Klinik für Hämatologie, Onkologie und Rheumatologie
ACTIVE_NOT_RECRUITING
Heidelberg
Universitätsklinikum Leipzig, Klinik und Poliklinik für Hämatologie, Zelltherapie und Hämostaseologie
RECRUITING
Leipzig
Kliniken Maria Hilf GmbH, Klinik für Hämatologie, Onkologie und Gastroenterologie
ACTIVE_NOT_RECRUITING
Mönchengladbach
Klinikum rechts der lsar der TU München, Klinik und Poliklinik für lnnere Medizin Ill
ACTIVE_NOT_RECRUITING
München
Rotkreuzklinikum München, III. Medizinische Abteilung
RECRUITING
München
Kliniken Sindelfingen,Medizinische Klinik I
ACTIVE_NOT_RECRUITING
Sindelfingen
Contact Information
Primary
Klaus Metzeler, Prof. Dr.
Klaus.Metzeler@medizin.uni-leipzig.de
+49 341 97-13050
Backup
Uwe Platzbecker, Prof. Dr.
uwe.platzbecker@medizin.uni-leipzig.de
+49 341 97-13050
Time Frame
Start Date: 2023-05-17
Estimated Completion Date: 2025-07
Participants
Target number of participants: 45
Treatments
Experimental: VEN+AZA-5
Azacitidine (AZA) 75 mg/m2, d1-5 of each 28 day cycle (SC) in combination with Venetoclax (VEN): 400 mg daily (orally)
Related Therapeutic Areas
Sponsors
Collaborators: University of Leipzig, Clinical Trial Centre (ZKS), AbbVie, University Hospital Leipzig, Hematology Diagnostics Laboratory
Leads: University of Leipzig