Leptin: A Marker for AML Chemo-Sensitivity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: AML, Adult. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Bone Marrow Supernatant Leptin as A Predictor of Chemotherapy Sensitivity in AML Patients
Overview
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.
Primary outcome measures
- ORR [Time frame: 1 month]
Secondary outcome measures (3)
- CR [Time frame: 1 month]
- CRi [Time frame: 1 month]
- PR [Time frame: 1 month]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Fujian Medical University Union Hospital — Fuzhou
Identifiers
NCT: NCT07163728 · AML-Leptin