Biomarkers in Bone Marrow Supernatant for Predicting AML Chemosensitivity

Bone Marrow Microenvironment Signatures for Predicting AML Prognosis and Resistance

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07587944

Enrollment

405

Registered

2026-05-14

Start date

2025-12-01

Completion date

2030-01-01

Last updated

2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult, AML

Keywords

AML, Chemosensitivity, Biomarker, Fumarate, Leptin, IL-6

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
ORR	The first month after the first chemotherapy	The primary endpoint of this study is the overall response rate (ORR) after Chemotherapy

Secondary

Measure	Time frame	Description
CR	The first month after the first chemotherapy	The secondary endpoints is the complete remission (CR) rate after Chemotherapy
CRi	The first month after the first chemotherapy	The secondary endpoints is the complete remission with incomplete blood count recovery (CRi) rate after Chemotherapy
PR	The first month after the first chemotherapy	The secondary endpoints is the partial remission (PR) rate after Chemotherapy
OS	3 year	The secondary endpoints is the overall survival (OS)

Countries

China

Contacts

CONTACTHuifang Huang

huanghuif@fjmu.edu.cn13365910318

Outcome results