IL-6: A Marker for AML Chemo Sensitivity

NCT ID: NCT06486350

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 72 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2025-06-30

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.

Conditions

AML, Adult

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Medical University Union Hospital

OTHER

Sponsor Role: lead

Responsible Party

Huifang Huang, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

Huifang Huang

Role: CONTACT

huanghuif@fjmu.edu.cn

13365910318 ext. 0591-86218641

Facility Contacts

huifang huang

Role: primary

huanghuif@fjmu.edu.cn

13365910318 ext. 0591-86218641

References

Hou D, Cai D, Dai W, Liao X, Tan M, Zheng X, Wang L, Liu J, Wang J, Wang X, Fu Q, Huang H. Targeting bone marrow mesenchymal stromal cell-derived IL-6 to overcome acute myeloid leukemia chemoresistance. Blood Adv. 2025 Oct 14;9(19):4810-4824. doi: 10.1182/bloodadvances.2024015496.

Reference Type: DERIVED

PMID: 40668612 (View on PubMed)

Other Identifiers

AML-IL6

Identifier Type: -

Identifier Source: org_study_id