Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prognostic Values of Next Generation Sequencing (NGS) in Acute Myeloid Leukemia Patients With Allo-HSCT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03715621
Recruitment Status : Not yet recruiting
First Posted : October 23, 2018
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Wu Depei, The First Affiliated Hospital of Soochow University

Brief Summary:
Acute myeloid leukemia (AML) is a genetically heterogeneous disease and allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a curative treatment option for AML except for AML-M3. Relapse remains the major cause of treatment failure after allo-HSCT. Molecular residual disease has been shown to be a strong risk factor for relapse after HSCT. In this study, the investigators will detect mutations before/after allo-HSCT by using next-generation sequencing (NGS) technique to measure residual disease and evaluate the prognostic impact of molecular residual disease in a cohort of AML participants receiving allo-HSCT.

Condition or disease
Acute Myeloid Leukemia

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: A Study of Prognostic Values of Next Generation Sequencing (NGS) in Acute Myeloid Leukemia Patients With Allo-HSCT
Estimated Study Start Date : October 15, 2018
Estimated Primary Completion Date : October 15, 2020
Estimated Study Completion Date : October 15, 2021





Primary Outcome Measures :
  1. 1-year relapse rate after allo-HSCT [ Time Frame: 1 year after allo-HSCT ]
    1-year relapse rate after allo-HSCT


Secondary Outcome Measures :
  1. 1-year recurrence-free survival (RFS) [ Time Frame: 1 year after allo-HSCT ]
    1-year recurrence-free survival for AML participants

  2. 1-year overall survival (OS) [ Time Frame: 1 year after allo-HSCT ]
    1-year overall survival (OS) for AML participants



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
subjects with the diagnosis of AML who is going to receive an allo-geneic HSCT within 30 days
Criteria

Inclusion Criteria:

  • 18 years or old;
  • Clinical diagnosis of acute myeloid leukemia (AML);
  • Availabe records of MICM and NGS results at diagnosis;
  • Be going to receive allo-HSCT.

Exclusion Criteria:

  • Active malignancy;
  • Pregnant or breast feeding women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03715621


Contacts
Layout table for location contacts
Contact: Xiang Zhang, master 8613382108261 lcsy2013@sina.com
Contact: Yang Xuyang, doctor 8613732628683 xuyang1020@126.com

Locations
Layout table for location information
China, Jiangsu
The First affiliated Hospital of SooChow University Not yet recruiting
Suzhou, Jiangsu, China, 215006
Contact: Xiang Zhang, MD    0512-67781856    lcsy2013@sina.com   
Contact: Yang Xu, doctor    0512-67781856    xuyang1020@126.com   
Sponsors and Collaborators
The First Affiliated Hospital of Soochow University
Investigators
Layout table for investigator information
Principal Investigator: Depei Wu, doctor The First Affiliated Hospital of Soochow University

Additional Information:

Publications:

Layout table for additonal information
Responsible Party: Wu Depei, professor, The First Affiliated Hospital of Soochow University
ClinicalTrials.gov Identifier: NCT03715621     History of Changes
Other Study ID Numbers: AML-NGS-2018
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wu Depei, The First Affiliated Hospital of Soochow University:
Acute Myeloid Leukemia
next generation sequencing
Hematopoietic Stem Cell Transplantation
Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms