Leptin as a marker of chemotherapy sensitivity in adult AML
Bone Marrow Supernatant Leptin as A Predictor of Chemotherapy Sensitivity in AML Patients
This study will test whether higher leptin levels in bone marrow predict poorer response to standard chemotherapy in adults with newly diagnosed AML.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 86 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fujian Medical University Union Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Fuzhou, Fujian) |
| Trial ID | NCT07163728 on ClinicalTrials.gov |
What this trial studies
In this prospective observational study, investigators will collect bone marrow supernatant from adults with newly diagnosed non-APL AML before any chemotherapy and measure leptin levels. Leptin concentrations will be correlated with treatment responses and clinical outcomes following standard chemotherapy to test whether higher leptin predicts chemoresistance and relapse. The approach links laboratory measures of marrow adipokines to real-world patient outcomes without changing standard care. The study is single-center at Fujian Medical University Union Hospital and excludes patients with prior chemotherapy, active major infections, other untreated malignancies, severe organ dysfunction, or inability to consent.
Who should consider this trial
Good fit: Adults with newly diagnosed non-APL AML who have not received prior chemotherapy and who can provide informed consent are the ideal candidates.
Not a fit: Patients with APL, prior chemotherapy exposure, concurrent untreated malignancies, active serious infections, severe liver or kidney dysfunction, or inability to understand/consent are unlikely to benefit from this biomarker-focused study.
Why it matters
Potential benefit: If successful, measuring bone marrow leptin could help identify patients at higher risk of chemotherapy failure and guide more personalized treatment planning.
How similar studies have performed: Preclinical and translational studies have linked marrow adipocytes and leptin to increased OXPHOS and chemoresistance in AML, but clinical validation of leptin as a predictive biomarker remains limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Fuzhou, Fujian
- Fujian Medical University Union Hospital — Fuzhou, Fujian, China (Recruiting)
Study contacts
- Study coordinator: Huifang Huang
- Email: huanghuif@fjmu.edu.cn
- Phone: 13365910318
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.