Clinical trial Recruiting at 1 site Observational Ages 18 and up

Leptin as a marker of chemotherapy sensitivity in adult AML

Official title: Bone Marrow Supernatant Leptin as A Predictor of Chemotherapy Sensitivity in AML Patients

Run by Fujian Medical University Union Hospital · NCT07163728 · Data updated 2026-11-12

This study will test whether higher leptin levels in bone marrow predict poorer response to standard chemotherapy in adults with newly diagnosed AML.

More AML trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment86 (estimated)
SponsorFujian Medical University Union Hospital
Academic / other
Drugs / interventionschemotherapy
Locations1 site (Fuzhou, Fujian)
StatusRecruiting
StartedAugust 1, 2025
Main results expectedJune 30, 2026
Study endsDecember 31, 2026
Registry record updatedSeptember 9, 2025
Trial IDNCT07163728 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Fujian Medical University Union Hospital
    Fuzhou, Fujian, China
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.