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RECRUITING
NCT07587944

Biomarkers in Bone Marrow Supernatant for Predicting AML Chemosensitivity

Sponsor: Fujian Medical University Union Hospital

View on ClinicalTrials.gov

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.

Official title: Bone Marrow Microenvironment Signatures for Predicting AML Prognosis and Resistance

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

405

Start Date

2025-12-01

Completion Date

2030-01-01

Last Updated

2026-05-14

Healthy Volunteers

Yes

Conditions

Locations (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, China