Leptin as a marker of chemotherapy sensitivity in adult AML
Official title: Bone Marrow Supernatant Leptin as A Predictor of Chemotherapy Sensitivity in AML Patients
Run by Fujian Medical University Union Hospital · NCT07163728 · Data updated 2026-11-12
This study will test whether higher leptin levels in bone marrow predict poorer response to standard chemotherapy in adults with newly diagnosed AML.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 86 (estimated) |
| Sponsor | Fujian Medical University Union Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Fuzhou, Fujian) |
| Status | Recruiting |
| Started | August 1, 2025 |
| Main results expected | June 30, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | September 9, 2025 |
| Trial ID | NCT07163728 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with newly diagnosed non-APL AML who have not received prior chemotherapy and who can provide informed consent are the ideal candidates.
✕Probably not a fit
Patients with APL, prior chemotherapy exposure, concurrent untreated malignancies, active serious infections, severe liver or kidney dysfunction, or inability to understand/consent are unlikely to benefit from this biomarker-focused study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this prospective observational study, investigators will collect bone marrow supernatant from adults with newly diagnosed non-APL AML before any chemotherapy and measure leptin levels. Leptin concentrations will be correlated with treatment responses and clinical outcomes following standard chemotherapy to test whether higher leptin predicts chemoresistance and relapse. The approach links laboratory measures of marrow adipokines to real-world patient outcomes without changing standard care. The study is single-center at Fujian Medical University Union Hospital and excludes patients with prior chemotherapy, active major infections, other untreated malignancies, severe organ dysfunction, or inability to consent.
Why it matters
Potential benefit: If successful, measuring bone marrow leptin could help identify patients at higher risk of chemotherapy failure and guide more personalized treatment planning.
How similar studies have gone: Preclinical and translational studies have linked marrow adipocytes and leptin to increased OXPHOS and chemoresistance in AML, but clinical validation of leptin as a predictive biomarker remains limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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: 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.
Where it's running
-
Fujian Medical University Union Hospital
Fuzhou, Fujian, China Recruiting
Study contacts
- Study coordinator: Huifang Huang
- Email: huanghuif@fjmu.edu.cn
- Phone: 13365910318
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
6MW5311 in adults with relapsed or refractory blood cancers
This study tests increasing doses of 6MW5311 in adults with multiple myeloma, AML, or CMML to see if it is safe and tolerable and to find a suitable dose for later studies.
-
CRD3874-SI in People with Leukemia
A small early-stage study tests CRD3874-SI to see if it is safe for adults with relapsed or refractory acute myeloid leukemia.
-
Allogeneic CAR-T CT0890B for relapsed/refractory AML
This study tests whether a universal CAR-T cell therapy called CT0890B is safe and potentially effective for adults with relapsed or refractory acute myeloid leukemia who express NKG2D ligands.
-
Biomarkers in Bone Marrow to Predict AML Chemosensitivity
This study tests whether markers in bone marrow can predict how adults with AML will respond to chemotherapy.
-
Azacitidine plus venetoclax maintenance vs azacitidine alone in AML
This trial tests whether adding venetoclax to azacitidine maintenance helps people with AML stay disease-free after achieving first remission.
-
Azacitidine with APG1252 in high-risk AML (Phase 1b/2)
This study tests whether adding APG1252 to azacitidine is safe and helps some patients with high-risk AML feel better or respond to treatment.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.