Biomarkers in Bone Marrow Supernatant for Predicting AML Chemosensitivity

NCT07587944 — Recruiting, 405 participants, Fujian Medical University Union Hospital

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Bone Marrow Microenvironment Signatures for Predicting AML Prognosis and Resistance

Registry	NCT07587944
Status	Recruiting
Study type	Observational
Enrollment	405 (Estimated)
Sponsor	Fujian Medical University Union Hospital (Other)
Conditions	AML, Adult
Dates	start 2025-12-01, primary completion 2027-12-31 (estimated), completion 2030-01-01 (estimated), first posted 2026-05-14, last updated 2026-05-14
Locations	1 site in China

-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.

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+Outcome measures

Primary outcomes

ORR [The first month after the first chemotherapy]: The primary endpoint of this study is the overall response rate (ORR) after Chemotherapy

Secondary outcomes

CR [The first month after the first chemotherapy]: The secondary endpoints is the complete remission (CR) rate after Chemotherapy
CRi [The first month after the first chemotherapy]: The secondary endpoints is the complete remission with incomplete blood count recovery (CRi) rate after Chemotherapy
PR [The first month after the first chemotherapy]: The secondary endpoints is the partial remission (PR) rate after Chemotherapy
OS [3 year]: The secondary endpoints is the overall survival (OS)

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

Inclusion Criteria:

1. Clinical diagnosis aligns with the "Chinese guidelines for diagnosis and treatment of adult acute myeloid leukemia (not APL) (2023)";
2. All patients are experiencing their first onset of the disease and have not received any related chemotherapy prior to the study;
3. Patients participate in the study accompanied by family members and sign informed consent documents.

Exclusion Criteria:

1. Patients with concurrent malignancies requiring treatment;
2. Presence of infectious diseases, including SARS, viral hepatitis, or HIV/ AIDS;
3. Major surgery performed within the last 21 days;
4. Performance Status (PS) score >3;
5. Severe liver or kidney dysfunction or serious infection;
6. Severe psychiatric conditions that impair understanding of the study protocol or voluntary withdrawal.

+Locations (1)

Facility	City	Country	Status
Fujian Medical University Union Hospital	Fuzhou, Fujian	China	Recruiting