Venetoclax in Combination with 5 Days Azacitidine in Untreated AML Patients, Not Eligible for Standard Induction Therapy

Launched by UNIVERSITY OF LEIPZIG · Apr 25, 2023

Keywords

ClinConnect Summary

This clinical trial, called the VENAZA-5S pilot trial, is exploring a new treatment approach for patients with Acute Myeloid Leukemia (AML) who are not able to receive standard therapies. The trial is studying the combination of two medications: Venetoclax (a pill taken daily) and Azacitidine (an injection given for a shorter period of 5 days during a 28-day cycle). This approach aims to make treatment easier to manage, potentially reducing side effects like infections and hospital visits, which can be especially important for older patients or those with other health issues.

To participate in this trial, individuals must be at least 18 years old and have a confirmed diagnosis of AML. They should not have previously received certain types of treatments for AML or related conditions. The trial is currently recruiting participants, and those who qualify can expect to receive the study medications and regular check-ups to monitor their health throughout the treatment. This study aims to improve the overall experience of AML treatment for those who are unable to tolerate more intensive therapies.

Gender

ALL

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)