Biomarkers in Bone Marrow Supernatant for Predicting AML Chemosensitivity

NCT07587944 | Recruiting

• 1 other identifier: Prognostic biomarkers for AML
• Study Type: observational
• Target: 405
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

AML; Adult

Keywords

AML; Chemosensitivity; Biomarker; Fumarate; Leptin; IL-6

Outcome Measures

Primary Outcomes (1)

• ORR

  The primary endpoint of this study is the overall response rate (ORR) after Chemotherapy

  The first month after the first chemotherapy

Secondary Outcomes (4)

• CR

  The first month after the first chemotherapy

• CRi

  The first month after the first chemotherapy

• PR

  The first month after the first chemotherapy

• OS

  3 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This prospective study enrolls patients who fulfill the diagnostic criteria for AML(excluding APL), with an age requirement of over 18 years and no restrictions on gender. Participation is entirely voluntary, with each participant or their legal guardian being thoroughly informed about the study details and signing an informed consent form. Participants are willing to adhere to and capable of completing all required study procedures.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bone marrow supernatant

Central Study Contacts

Huifang Huang

CONTACT

13365910318; huanghuif@fjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 14, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): January 1, 2030
• Last Updated: May 14, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)