Risk-stratified Therapy Based on Molecular Cytogenetic Aberration and Treatment Response in AML

NCT03620955 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2019-11-04

No results posted yet for this study

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.

Conditions

  • Risk-directed Therapy
  • Cytogenetic Abnormality
  • Molecular Abnormality
  • MRD

Interventions

OTHER

Justified risk stratification based on MRD after three course chemo therapy

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.

Sponsors & Collaborators

  • Second Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER
  • Third Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER
  • Guangzhou First People's Hospital

    collaborator OTHER
  • Wuhan General Hospital of Guangzhou Military Command

    collaborator OTHER
  • Shenzhen Hospital of Southern Medical University

    collaborator OTHER
  • Peking University Shenzhen Hospital

    collaborator OTHER
  • Shenzhen Second People's Hospital

    collaborator OTHER
  • Zhongshan People's Hospital, Guangdong, China

    collaborator OTHER
  • First Affiliated Hospital of Guangxi Medical University

    collaborator OTHER
  • Xiangya Hospital of Central South University

    collaborator OTHER
  • The Third Xiangya Hospital of Central South University

    collaborator OTHER
  • First Affiliated Hospital of Gannan Medical University

    collaborator OTHER
  • Peking University People's Hospital

    collaborator OTHER
  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    collaborator OTHER
  • The First Affiliated Hospital of Zhengzhou University

    collaborator OTHER
  • Chenzhou NO. 1 people's Hospital

    collaborator UNKNOWN
  • Nanfang Hospital, Southern Medical University

    lead OTHER

Principal Investigators

  • Qifa Liu · Nanfang Hospital, Southern Medical University

Eligibility

Min Age
14 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-10
Primary Completion
2020-12-31
Completion
2021-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03620955 on ClinicalTrials.gov