About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
ORR
The primary endpoint of this study is the overall response rate (ORR) after Chemotherapy
Secondary outcomes
CR
The secondary endpoints is the complete remission (CR) rate after Chemotherapy
CRi
The secondary endpoints is the complete remission with incomplete blood count recovery (CRi) rate after Chemotherapy
PR
The secondary endpoints is the partial remission (PR) rate after Chemotherapy
OS
The secondary endpoints is the overall survival (OS)
Sponsors and contacts
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