Clinical Trial

Biomarkers in Bone Marrow Supernatant for Predicting AML Chemosensitivity

Recruiting
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Summary
Chemoresistance in acute myeloid leukemia (AML) is closely associated with the bone marrow microenvironment. Elevated levels of IL-6, leptin, fumarate, and other factors within the bone marrow microenvironment have been shown to enhance oxidative phosphorylation or antioxidant capacity in AML cells, thereby inducing chemoresistance. To explore their potential as prognostic biomarkers or therapeutic targets, this study plans to enroll 405 newly diagnosed AML patients meeting the criteria of the Chinese Guidelines for the Diagnosis and Treatment of Adult Acute Myeloid Leukemia (2023 Edition), along with 81 sex- and age-matched healthy controls. By analyzing the levels of IL-6, leptin, fumarate, and other factors in patient bone marrow supernatant, we will evaluate their associations with treatment response (primary endpoints: overall survival \[OS\] and overall response rate \[ORR\] after one cycle of chemotherapy) and prognosis. Furthermore, patient-derived xenograft (PDX) mouse models established from primary AML cells will be used to validate their roles in chemoresistance, aiming to provide a basis for therapies targeting the bone marrow microenvironment.
Trial Details
NCT Number NCT07587944
Lead Sponsor Fujian Medical University Union Hospital
Conditions AML, Adult
Enrollment 405 participants
Start Date 2025-12-01
Primary Completion 2027-12-31 (estimated)
Study Completion 2030-01-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-14