Risk-stratified Therapy Based on Molecular Cytogenetic Aberration and Treatment Response in AML
1 other identifier
observational
1,000
1 country
1
Brief Summary
Risk-stratified therapy based on molecular and cytogenetic for acute myeloid leukemia (AML) is well accepted and benefits patients' survival. However, neither every patient with low risk factors obtains better survival, nor all high risk patients experience worse outcome. Lots of data have shown that the early treatment response presenting as minimal residual disease (MRD) has an important role in prognostic prediction. In this study, we perform risk stratification based on not only Cytogenetic and Molecular characteristic, but also MRD after three courses of chemo therapy in AML cohort. Patients with MRD positive would be moved to a higher risk class. And then the risk-stratified therapy should be considered according to the new risk stratification.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2018
CompletedFirst Posted
Study publicly available on registry
August 8, 2018
CompletedStudy Start
First participant enrolled
August 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedNovember 4, 2019
October 1, 2019
2.3 years
August 5, 2018
October 31, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
relapse rate
2 year
Secondary Outcomes (2)
overall survival (OS)
2 year
disease-free survival (DFS)
2 year
Study Arms (1)
Risk stratification
Risk stratification based on cytogenetic and molecular and MRD level after three courses of chemo therapy.
Interventions
All patients are routinely divided into different risk groups according to the NCCN guild based on cytogenetic and molecular abnormality. Then all patients are treated with anthracycline combined with cytarabine regimens for two courses . The patients without obtaining CR will go on one cycle of salvage therapy and then be bridged to allo-HSCT. Those acquiring CR will be given one more course of HDAC as consolidation treatment and then be detested MRD with flow cytometry after that. The patients with MRD positive would be moved to a higher risk class.The stratified therapy should be considered according to the new risk stratification.
Eligibility Criteria
All newly diagnosed AML exclusively of APL with age range from 14 to 60-year old.
You may qualify if:
- All newly diagnosed AML exclusively of APL with age range from 14 to 60-year old
You may not qualify if:
- Any abnormality in a vital sign (e.g., organ function failure, serious infection ) Patients with any conditions not suitable for the trial (investigators' decision)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nanfang Hospital, Southern Medical Universitylead
- Second Affiliated Hospital, Sun Yat-Sen Universitycollaborator
- Third Affiliated Hospital, Sun Yat-Sen Universitycollaborator
- Guangzhou First People's Hospitalcollaborator
- Wuhan General Hospital of Guangzhou Military Commandcollaborator
- Shenzhen Hospital of Southern Medical Universitycollaborator
- Peking University Shenzhen Hospitalcollaborator
- Shenzhen Second People's Hospitalcollaborator
- Zhongshan People's Hospital, Guangdong, Chinacollaborator
- First Affiliated Hospital of Guangxi Medical Universitycollaborator
- Xiangya Hospital of Central South Universitycollaborator
- The Third Xiangya Hospital of Central South Universitycollaborator
- First Affiliated Hospital of Gannan Medical Universitycollaborator
- Peking University People's Hospitalcollaborator
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicinecollaborator
- The First Affiliated Hospital of Zhengzhou Universitycollaborator
- Chenzhou NO. 1 people's Hospitalcollaborator
Study Sites (1)
Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515, China
Related Publications (1)
Zhang Y, Feng Z, Du J, Liu H, Yu S, Liang X, Zhao W, Zhang Q, Zhang X, Nie D, Sun Z, Du X, Xu X, Yu G, Shi P, Liu Q, Shao R, Qu H, Xiong W, Wang S, Jiang Y, Zhang H, Guo Z, Dai M, Jiang X, Xu D, Huang F, Fan Z, Xu N, Liu C, Wu M, Lin R, Jin H, Sun J, Liu Q, Xuan L. High-dose cytarabine with idarubicin consolidation for acute myeloid leukemia in first complete remission: a randomized controlled trial. Leukemia. 2025 Aug;39(8):1857-1864. doi: 10.1038/s41375-025-02655-x. Epub 2025 May 28.
PMID: 40437173DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Qifa Liu
Nanfang Hospital, Southern Medical University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
August 5, 2018
First Posted
August 8, 2018
Study Start
August 10, 2018
Primary Completion
December 1, 2020
Study Completion
December 1, 2021
Last Updated
November 4, 2019
Record last verified: 2019-10