AMLNCT07587944
Biomarkers in Bone Marrow Supernatant for Predicting AML Chemosensitivity
An observational study of AML and Adult, run by Fujian Medical University Union Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- How many people
- 405 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 1 Jan 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian
Huifang Huang, 13365910318 ext. 0591-86218641, huanghuif@fjmu.edu.cn
About this study
Official title: Bone Marrow Microenvironment Signatures for Predicting AML Prognosis and Resistance
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.
- Keywords
- AML, Chemosensitivity, Biomarker, Fumarate, Leptin, IL-6
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
The primary endpoint of this study is the overall response rate (ORR) after Chemotherapy
Measured: The first month after the first chemotherapy
Secondary outcomes (4)
CR
The secondary endpoints is the complete remission (CR) rate after Chemotherapy
Measured: The first month after the first chemotherapy
CRi
The secondary endpoints is the complete remission with incomplete blood count recovery (CRi) rate after Chemotherapy
Measured: The first month after the first chemotherapy
PR
The secondary endpoints is the partial remission (PR) rate after Chemotherapy
Measured: The first month after the first chemotherapy
OS
The secondary endpoints is the overall survival (OS)
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start1 Dec 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 405 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07587944
- Sponsor's protocol ID
- Prognostic biomarkers for AML
- Status last verified
- Dec 2025
- First submitted
- 8 May 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No