Studying How Azacitidine and Venetoclax Affect the Immune Environment in Adults with Acute Myeloid Leukemia Who Cannot Have Intensive Chemotherapy

What this Trial Is About

Researchers are studying the immune environment within the bone marrow of adults newly diagnosed with acute myeloid leukemia AML who are not eligible for intensive chemotherapy. This observational study aims to understand how the combination of azacitidine and venetoclax treatment affects this microenvironment, focusing on immune pathways such as IDO1 and AHR that may influence treatment response and survival. The study seeks to uncover mechanisms behind why some patients respond to immunotherapy while others do not, correlating these findings with clinical outcomes. Participants will receive standard front-line treatment with azacitidine and venetoclax as part of routine care. Samples of blood, bone marrow, and urine will be collected at diagnosis and after the second treatment cycle about two months after starting therapy. Healthy donors will also contribute blood samples for comparison. Laboratory analyses include multiomic techniques such as RNA sequencing, metabolomics, and immune profiling to explore cellular composition and function related to treatment response. During the study, participants will undergo sample collection aligned with their clinical visits and treatment schedule. Researchers will measure immune signatures, metabolic changes in T cells, and clinical responses such as remission or resistance. Survival will be tracked for up to 12 months following treatment initiation. The study duration is approximately 36 months, including enrollment, sample collection, data analysis, and follow-up periods.

Targeting Acute Myeloid Leukemia Immunosuppressive Microenvironment by combinedIDO1 Inhibition and PD-1 Blockade