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)
University of Leipzig
45 participants
May 17, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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
Exclusion Criteria9
- 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)
Interventions
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)
View Full Details on ClinicalTrials.gov
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NCT05833438