Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT07587944

Biomarkers in Bone Marrow Supernatant for Predicting AML Chemosensitivity

Led by Fujian Medical University Union Hospital · Updated on 2026-05-14

405

Participants Needed

1

Research Sites

213 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Biomarkers in Bone Marrow Supernatant for Predicting AML Chemosensitivity

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical diagnosis follows the Chinese guidelines for diagnosis and treatment of adult acute myeloid leukemia (not APL) (2023)
  • First onset of acute myeloid leukemia without prior chemotherapy
  • Participation with family members and signed informed consent
Not Eligible

You will not qualify if you...

  • Presence of other malignancies requiring treatment
  • Infectious diseases including SARS, viral hepatitis, or HIV/AIDS
  • Major surgery within the last 21 days
  • Performance Status score greater than 3
  • Severe liver or kidney dysfunction or serious infection
  • Severe psychiatric conditions affecting understanding or voluntary withdrawal

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Actively Recruiting

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Research Team

H

Huifang Huang

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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