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NCT Number: NCT07587944

Biomarkers in Bone Marrow Supernatant for Predicting AML Chemosensitivity

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Location status: Recruiting

Location contact

Huifang Huang

CONTACT

[email protected]

13365910318 ext. 0591-86218641

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. ORR

    Time frame: The first month after the first chemotherapy

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

Secondary outcomes

  1. CR

    Time frame: The first month after the first chemotherapy

    The secondary endpoints is the complete remission (CR) rate after Chemotherapy

  2. CRi

    Time frame: The first month after the first chemotherapy

    The secondary endpoints is the complete remission with incomplete blood count recovery (CRi) rate after Chemotherapy

  3. PR

    Time frame: The first month after the first chemotherapy

    The secondary endpoints is the partial remission (PR) rate after Chemotherapy

  4. OS

    Time frame: 3 year

    The secondary endpoints is the overall survival (OS)

Study contacts

Contact information is provided by the study sponsor or research team.

Huifang Huang

CONTACT

[email protected]

13365910318 ext. 0591-86218641

Sponsors and collaborators

Lead sponsor

Fujian Medical University Union Hospital

Other

Registry information

Official study title

Bone Marrow Microenvironment Signatures for Predicting AML Prognosis and Resistance

Important dates

Study start
2025
Primary completion
2027
Study completion
2030
First posted
May 14, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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