NCT07587944 Biomarkers in Bone Marrow Supernatant for Predicting AML Chemosensitivity
| NCT ID | NCT07587944 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fujian Medical University Union Hospital |
| Condition | AML |
| Study Type | OBSERVATIONAL |
| Enrollment | 405 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 405 participants in total. It began in 2025-12-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Chemoresistance in acute myeloid leukemia (AML) is closely associated with the bone marrow microenvironment. Elevated levels of IL-6, leptin, fumarate, and other factors within the bone marrow microenvironment have been shown to enhance oxidative phosphorylation or antioxidant capacity in AML cells, thereby inducing chemoresistance. To explore their potential as prognostic biomarkers or therapeutic targets, this study plans to enroll 405 newly diagnosed AML patients meeting the criteria of the Chinese Guidelines for the Diagnosis and Treatment of Adult Acute Myeloid Leukemia (2023 Edition), along with 81 sex- and age-matched healthy controls. By analyzing the levels of IL-6, leptin, fumarate, and other factors in patient bone marrow supernatant, we will evaluate their associations with treatment response (primary endpoints: overall survival \[OS\] and overall response rate \[ORR\] after one cycle of chemotherapy) and prognosis. Furthermore, patient-derived xenograft (PDX) mouse models established from primary AML cells will be used to validate their roles in chemoresistance, aiming to provide a basis for therapies targeting the bone marrow microenvironment.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07587944 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying AML. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07587944 currently recruiting?
Yes, NCT07587944 is actively recruiting participants. Contact the research team at huanghuif@fjmu.edu.cn for enrollment information.
Where is the NCT07587944 trial being conducted?
This trial is being conducted at Fuzhou, China.
Who is sponsoring the NCT07587944 clinical trial?
NCT07587944 is sponsored by Fujian Medical University Union Hospital. The trial plans to enroll 405 participants.