Leptin: A Marker for AML Chemo-Sensitivity

NCT ID: NCT07163728

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 86 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2026-12-31

Brief Summary

Acute Myeloid Leukemia (AML) is a malignant clonal disorder of hematopoietic stem/progenitor cells, with a five-year survival rate of approximately 30%. Chemotherapy resistance and relapse remain major challenges. Increased bone marrow adipocytes contribute to AML cell drug resistance.This study found that elevated levels of the adipokine leptin enhance oxidative phosphorylation (OXPHOS) in AML cells, accompanied by increased mitochondrial reactive oxygen species (mtROS), which stimulates antioxidant capacity and thereby induces chemotherapy resistance. By establishing a correlation between leptin levels in bone marrow supernatant and clinical outcomes in AML patients, this research provides novel strategic insights for targeting drug resistance and improving prognostic evaluation.

Detailed Description

In this prospective study, we will collect bone marrow supernatant samples from patients diagnosed with Acute Myeloid Leukemia (AML) to evaluate the levels of leptin. Our aim is to explore whether elevated leptin levels can serve as a predictive biomarker for poor treatment outcomes following standard chemotherapy regimens. The findings may help in stratifying patient risk and personalizing therapeutic approaches in AML treatment.

Conditions

AML; Adult

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Medical University Union Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Huifang Huang

Role: STUDY_DIRECTOR

Fujian Medical University Union Hospital

Locations

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

Huifang Huang

Role: CONTACT

huanghuif@fjmu.edu.cn

13365910318

Facility Contacts

huifang huang

Role: primary

huanghuif@fjmu.edu.cn

13365910318

Other Identifiers

AML-Leptin

Identifier Type: -

Identifier Source: org_study_id