Clinical Research Directory
Browse clinical research sites, groups, and studies.
Venetoclax in Combination with 5 Days Azacitidine in Untreated AML Patients, Not Eligible for Standard Induction Therapy
Sponsor: University of Leipzig
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
45
Start Date
2023-05-17
Completion Date
2025-07
Last Updated
2024-12-09
Healthy Volunteers
No
Conditions
Interventions
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)
Locations (10)
Helios Klinikum Berlin-Buch Klinik für Hämatologie und Stammzelltransplantation
Berlin, Germany
Klinikum Chemnitz gGmbH Klinik für lnnere Medizin Ill
Chemnitz, Germany
Carl-Thiem-Klinikum Cottbus gGmbH
Cottbus, Germany
Universitatsklinikum Carl Gustav Carus Dresden an der TU Dresden Medizinische Klinik und Poliklinik 1 Bereich Hamatologie
Dresden, Germany
Universitätsklinikum Heidelberg, Innere Medizin V; Klinik für Hämatologie, Onkologie und Rheumatologie
Heidelberg, Germany
Universitätsklinikum Leipzig, Klinik und Poliklinik für Hämatologie, Zelltherapie und Hämostaseologie
Leipzig, Germany
Kliniken Maria Hilf GmbH, Klinik für Hämatologie, Onkologie und Gastroenterologie
Mönchengladbach, Germany
Rotkreuzklinikum München, III. Medizinische Abteilung
München, Germany
Klinikum rechts der lsar der TU München, Klinik und Poliklinik für lnnere Medizin Ill
München, Germany
Kliniken Sindelfingen,Medizinische Klinik I
Sindelfingen, Germany