Venetoclax in Combination With 5 Days Azacitidine in Untreated AML Patients, Not Eligible for Standard Induction Therapy (VENAZA-5S)
Acute Myeloid Leukemia (AML)
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia (AML) focused on measuring Venclyxto, Venetoclax, Azacitidine, Hematologic Diseases, Acute Myelogenous Leukemia
Eligibility 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)
Sites / Locations
- Helios Klinikum Berlin-Buch Klinik für Hämatologie und StammzelltransplantationRecruiting
- Klinikum Chemnitz gGmbH Klinik für lnnere Medizin Ill
- Carl-Thiem-Klinikum Cottbus gGmbHRecruiting
- Universitatsklinikum Carl Gustav Carus Dresden an der TU Dresden Medizinische Klinik und Poliklinik 1 Bereich Hamatologie
- Universitätsklinikum Heidelberg, Innere Medizin V; Klinik für Hämatologie, Onkologie und Rheumatologie
- Universitätsklinikum Leipzig, Klinik und Poliklinik für Hämatologie, Zelltherapie und HämostaseologieRecruiting
- Kliniken Maria Hilf GmbH, Klinik für Hämatologie, Onkologie und Gastroenterologie
- Rotkreuzklinikum München, III. Medizinische AbteilungRecruiting
- Klinikum rechts der lsar der TU München, Klinik und Poliklinik für lnnere Medizin Ill
- Kliniken Sindelfingen,Medizinische Klinik I
Arms of the Study
Arm 1
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)