AMLNCT07163728
Leptin: A Marker for AML Chemo-Sensitivity
An observational study of AML and Adult, run by Fujian Medical University Union Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 31 Dec 2026
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
huifang huang, 13365910318, huanghuif@fjmu.edu.cn
About this study
Official title: Bone Marrow Supernatant Leptin as A Predictor of Chemotherapy Sensitivity in AML Patients
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.
- Keywords
- AML, Leptin, Chemotherapy sensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
The primary endpoint of this study is the overall response rate (ORR) after Chemotherapy
Measured: 1 month
Secondary outcomes (3)
CR
The secondary endpoints is the complete remission (CR) rate after Chemotherapy
Measured: 1 month
CRi
The secondary endpoints is the complete remission with incomplete blood count recovery (CRi) rate after Chemotherapy
Measured: 1 month
PR
The secondary endpoints is the partial remission (PR) rate after Chemotherapy
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start1 Aug 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMLStudies of the same condition, open and under way.
- More trials run by Fujian Medical University Union HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huifang Huang, Study director, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07163728
- Sponsor's protocol ID
- AML-Leptin
- Status last verified
- Aug 2025
- First submitted
- 2 Sep 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Marrow Supernatant Leptin as A Predictor of Chemotherapy Sensitivity in AML Patients
- ClinicalTrials.gov ID
- NCT07163728
- Acronym / sponsor ID
- AML-Leptin
- Keywords
- AML, Leptin, Chemotherapy sensitivity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ORR
Time frame: 1 month
The primary endpoint of this study is the overall response rate (ORR) after Chemotherapy
3 secondary outcomes
CR
Time frame: 1 month
CRi
Time frame: 1 month
PR
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Huifang Huang study director
Fujian Medical University Union Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AML and Adult, run by Fujian Medical University Union Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huifang Huang (13365910318, huanghuif@fjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.