IL-6: A Marker for AML Chemo Sensitivity

NCT06486350 | Recruiting

• 1 other identifier: AML-IL6
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

AML, Adult

Keywords

AML; IL-6; Chemotherapy sensitivity

Outcome Measures

Primary Outcomes (1)

• ORR

  The primary endpoint of this study is the overall response rate (ORR) after Chemotherapy

  1 year

Secondary Outcomes (4)

• CR

  1 year

• CRi

  1 year

• PR

  1 year

• OS

  2 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Severe liver or kidney dysfunction or serious infection;
• Severe psychiatric conditions that impair understanding of the study protocol or voluntary withdrawal.

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 40668612 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bone marrow supernatant

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Huifang Huang

CONTACT

13365910318; huanghuif@fjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: July 3, 2024
• Study Start: October 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: June 1, 2025
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)