Biomarkers in Bone Marrow to Predict AML Chemosensitivity
Official title: Bone Marrow Microenvironment Signatures for Predicting AML Prognosis and Resistance
Run by Fujian Medical University Union Hospital · NCT07587944 · Data updated 2026-11-12
This study tests whether markers in bone marrow can predict how adults with AML will respond to chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 405 (estimated) |
| Sponsor | Fujian Medical University Union Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Fuzhou, Fujian) |
| Status | Recruiting |
| Started | December 1, 2025 |
| Main results expected | December 31, 2027 |
| Study ends | January 1, 2030 |
| Registry record updated | May 14, 2026 |
| Trial ID | NCT07587944 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with first onset AML who meet the 2023 Chinese guidelines and provide informed consent, with no prior AML chemotherapy, and with familial support.
✕Probably not a fit
Patients whose biomarker levels do not correlate with treatment response may see no differential benefit from biomarker testing.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study analyzes bone marrow supernatant from adults with newly diagnosed AML to identify biomarkers such as IL-6, leptin, and fumarate that may be linked to chemoresistance. The study will compare patients with healthy controls and examine associations between biomarker levels and treatment response after one chemotherapy cycle, as well as overall survival and ORR. Patient-derived xenograft models are planned to explore functional links between the marrow environment and chemosensitivity. The research is conducted at Fujian Medical University Union Hospital in China, enrolling up to 405 AML patients and 81 matched controls.
Why it matters
Potential benefit: If biomarkers reliably predict chemosensitivity, they could guide personalized treatment decisions in AML.
How similar studies have gone: Prior research has linked marrow factors to AML biology; this study extends those findings with a larger, prospective cohort and PDX models.
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
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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.