IL-6: A Marker for AML Chemo Sensitivity

Recruiting

• Conditions: AML, Adult

• Registration Number: NCT06486350
• Lead Sponsor: Fujian Medical University Union Hospital

Brief Summary

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.

Detailed Description

In this prospective study, we will collect bone marrow supernatant samples from patients diagnosed with Acute Myeloid Leukemia (AML) to evaluate the levels of Interleukin-6 (IL-6). Our aim is to explore whether elevated IL-6 levels can serve as a predictive biomarker for poor treatment outcomes following standard chemotherapy regimens. The findings may help in stratifying patient risk and personalizing therapeutic approaches in AML treatment.

Study Timeline

• Study Start: 2023-10-01
• Status Verified: 2024-06
• Study First Submitted: 2024-06-19
• Study First Submitted QC: 2024-06-30
• Last Update Submitted: 2024-06-30
• Study First Posted: 2024-07-03
• Last Update Posted: 2024-07-03
• Primary Completion: 2024-10
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ORR	1 year	The primary endpoint of this study is the overall response rate (ORR) after Chemotherapy

Secondary Outcome Measures

Name	Time	Method
CR	1 year	The secondary endpoints is the complete remission (CR) rate after Chemotherapy
CRi	1 year	The secondary endpoints is the complete remission with incomplete blood count recovery (CRi) rate after Chemotherapy
PR	1 year	The secondary endpoints is the partial remission (PR) rate after Chemotherapy
OS	2 year	The secondary endpoints is the overall survival (OS)

Trial Locations

Locations (1)

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China