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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.
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| Measure | Description | Time Frame |
|---|---|---|
| ORR | The primary endpoint of this study is the overall response rate (ORR) after Chemotherapy | The first month after the first chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| CR | The secondary endpoints is the complete remission (CR) rate after Chemotherapy | The first month after the first chemotherapy |
| CRi | The secondary endpoints is the complete remission with incomplete blood count recovery (CRi) rate after Chemotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huifang Huang | Contact | 13365910318 | 0591-86218641 | huanghuif@fjmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Medical University Union Hospital | Recruiting | Fuzhou | Fujian | China |
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Bone marrow supernatant
| The first month after the first chemotherapy |
| PR | The secondary endpoints is the partial remission (PR) rate after Chemotherapy | The first month after the first chemotherapy |
| OS | The secondary endpoints is the overall survival (OS) | 3 year |