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RecruitingNCT07163728Updated Sep 9, 2025

Leptin: A Marker for AML Chemo-Sensitivity

An observational study in AML and Adult, sponsored by Fujian Medical University Union Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-09.

Sponsored by Fujian Medical University Union Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Aug 2025; still recruiting 1 year 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
86
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • AML
  • Adult

Keywords

  • AML
  • Leptin
  • Chemotherapy sensitivity
03

In context

Lead sponsor

Fujian Medical University Union Hospital is the lead sponsor of 100 studies on the registry; 72 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study 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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
86 participants (estimated)
Target follow-up
1 Month
Patient registry
Yes
Biospecimen retention
Samples without dna
06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
  • Fujian Medical University Union Hospital
    Fuzhou, Fujian 350001, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07163728
Lead sponsor
Fujian Medical University Union Hospital
Responsible party
Sponsor
First posted
Sep 9, 2025
Start date
Aug 1, 2025
Primary completion
Jun 30, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Sep 9, 2025

Study contacts

Huifang Huang
Contact
huanghuif@fjmu.edu.cn
13365910318
Huifang Huang
study director · Fujian Medical University Union Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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