Leptin: A Marker for AML Chemo-Sensitivity

NCT07163728 | Recruiting

• 1 other identifier: AML-Leptin
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

AML; Adult

Keywords

AML; Leptin; Chemotherapy sensitivity

Outcome Measures

Primary Outcomes (1)

• ORR

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

  1 month

Secondary Outcomes (3)

• CR

  1 month

• CRi

  1 month

• PR

  1 month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• 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, 350001, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bone marrow supernatant

Study Officials

• Huifang Huang

  Fujian Medical University Union Hospital

  STUDY DIRECTOR

Central Study Contacts

Huifang Huang

CONTACT

13365910318; huanghuif@fjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 9, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)