Leptin: A Marker for AML Chemo-Sensitivity

ConditionsAMLAdult
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFujian Medical University Union Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

ORR

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

Time frame
1 month

Secondary outcomes

1

CR

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

Time frame
1 month
2

CRi

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

Time frame
1 month
3

PR

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

Time frame
1 month

Other outcomes

Sponsors and contacts

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