A Study to Assess Change in Disease State in Adult Participants With Acute Myeloid Leukemia (AML) Receiving Oral Venetoclax Tablets in Combination With Subcutaneously (SC) or Intravenously (IV) Injected Azacitidine in Colombia

Launched by ABBVIE · Oct 18, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating how well a combination of two medications, venetoclax and azacitidine, works to treat a type of blood cancer called acute myeloid leukemia (AML) in adults in Colombia. The study aims to find out if this combination can improve the health of people newly diagnosed with AML. About 70 participants will be involved, and everyone will take venetoclax as a pill and receive azacitidine through an injection, either just under the skin or into a vein. The trial will last about 36 months, but participants will not have to undergo any extra procedures beyond their usual doctor visits.

To be eligible for this study, participants must have a recent diagnosis of AML, meaning they have not received any treatment for it yet. They should be 75 years or older or between 18 and 74 years old with other health conditions that make intensive chemotherapy too risky. Importantly, those who have participated in another clinical trial within the last 30 days cannot join this study. The goal is to ensure that participants receive the best possible care while evaluating the effectiveness of this treatment combination.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Newly diagnosed acute myeloid leukemia (AML) defined as participants that have histological confirmation of AML (de novo, secondary) by World Health Organization (WHO) criteria, and have not received any prior treatment for AML.
• • Ineligible to intensive chemotherapy due to \>=75 years of age; or \>=18 to 74 years who have comorbidities that preclude use of intensive induction chemotherapy.
• • Participants starting treatment with venetoclax in combination with azacytidine treated according to the Colombia label and who are not completed the first cycle (Cycle 28 days).
• Exclusion Criteria:
• • - Participating in an interventional clinical trial within 30 days prior to Venetoclax treatment initiation.