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NCT Number: NCT07163728

Leptin: A Marker for AML Chemo-Sensitivity

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Location status: Recruiting

Location contact

huifang huang

CONTACT

[email protected]

13365910318

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. ORR

    Time frame: 1 month

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

Secondary outcomes

  1. CR

    Time frame: 1 month

    The secondary endpoints is the complete remission (CR) rate after Chemotherapy

  2. CRi

    Time frame: 1 month

    The secondary endpoints is the complete remission with incomplete blood count recovery (CRi) rate after Chemotherapy

  3. PR

    Time frame: 1 month

    The secondary endpoints is the partial remission (PR) rate after Chemotherapy

Study contacts

Contact information is provided by the study sponsor or research team.

Huifang Huang

CONTACT

[email protected]

13365910318

Sponsors and collaborators

Lead sponsor

Fujian Medical University Union Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 9, 2025
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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