IL-6: A Marker for AML Chemo Sensitivity
ConditionAML, Adult
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFujian Medical University Union Hospital
About this trial
Acute myeloid leukemia (AML) is a clonal malignancy that arises from the primitive hematopoietic cells within the hematopoietic system. According to SEER cancer statistics, the 5-year survival rate for AML patients stands at a concerning 30%. Despite therapeutic advancements, the development of chemotherapy resistance and the risk of disease relapse pose significant barriers to curative outcomes. Evidence has linked elevated interleukin-6 (IL-6) levels in plasma and bone marrow to a poorer prognosis in AML, with IL-6 potentially fostering chemotherapy resistance through the enhancement of fatty acid uptake and the induction of stromal-like morphological changes in AML cells. However, the role of IL-6 as a potential biomarker for monitoring chemotherapy sensitivity in AML has not been fully elucidated. This study seeks to investigate the correlation between IL-6 levels in bone marrow supernatant and the sensitivity to chemotherapy, offering a clinical perspective that could pave the way for improved prognostic markers and personalized treatment strategies.
Eligibility criteria
This trial does not accept 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
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
ORR
The primary endpoint of this study is the overall response rate (ORR) after Chemotherapy
Time frame
1 yearSecondary outcomes
1
CR
The secondary endpoints is the complete remission (CR) rate after Chemotherapy
Time frame
1 year2
CRi
The secondary endpoints is the complete remission with incomplete blood count recovery (CRi) rate after Chemotherapy
Time frame
1 year3
PR
The secondary endpoints is the partial remission (PR) rate after Chemotherapy
Time frame
1 year4
OS
The secondary endpoints is the overall survival (OS)
Time frame
2 yearSponsors and contacts
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Source ClinicalTrials.gov