Back to resultsMycophenolate Mofetil for the Prophylaxis of Graft-versus-host Disease in High Risk Allogeneic Stem Cell Transplantation
Primary Purpose
Graft vs Host Disease, Hematopoietic Stem Cell Transplantation
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
mycophenolate mofetil, methotrexate, cyclosporin
Methotrexate and cyclosporin
Sponsored by
About this trial
This is an interventional prevention trial for Graft vs Host Disease focused on measuring Acute graft-versus-host disease post high risk allogeneic stem cell transplantation
Eligibility Criteria
Inclusion Criteria:
- patients undergoing allogeneic SCT with high risk of acute GVHD, ie. from matched unrelated donor or one HLA-locus mismatch sibling
Exclusion Criteria:
- known allergy to mycophenolate mofetil
Sites / Locations
- Queen Mary HospitalRecruiting
Outcomes
Primary Outcome Measures
acute GVHD incidence and grading
chronic GVHD incidence
Secondary Outcome Measures
Mortality, GVHD-related and all cause
Symptomatic side effects attributed to MMF
Date of engraftment
Full Information
NCT ID
NCT00563589
First Posted
November 21, 2007
Last Updated
July 6, 2010
Sponsor
Hospital Authority, Hong Kong
Collaborators
Hoffmann-La Roche
1. Study Identification
Unique Protocol Identification Number
NCT00563589
Brief Title
Mycophenolate Mofetil for the Prophylaxis of Graft-versus-host Disease in High Risk Allogeneic Stem Cell Transplantation
Official Title
A Randomized Single-center Trial of Mycophenolate Mofetil for the Prophylaxis of Graft-versus-host Disease in High Risk Allogeneic Stem Cell Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Authority, Hong Kong
Collaborators
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
There is a significant (50-80%) risk of acute graft-versus-host disease(GVHD) and early mortality (30%) associated with high risk stem cell transplantation (SCT) such as that from a matched unrelated donor or HLA-mismatch sibling. Mycophenolate mofetil (MMF) has been shown to be an effective and safe immunosuppressant in the prevention and treatment of rejection after solid organ transplantation. Its role in acute GVHD prophylaxis in high risk SCT will be investigated in this clinical trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft vs Host Disease, Hematopoietic Stem Cell Transplantation
Keywords
Acute graft-versus-host disease post high risk allogeneic stem cell transplantation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
mycophenolate mofetil, methotrexate, cyclosporin
Intervention Type
Drug
Intervention Name(s)
Methotrexate and cyclosporin
Primary Outcome Measure Information:
Title
acute GVHD incidence and grading
Time Frame
100 Days
Title
chronic GVHD incidence
Time Frame
3 Years
Secondary Outcome Measure Information:
Title
Mortality, GVHD-related and all cause
Time Frame
3 Years
Title
Symptomatic side effects attributed to MMF
Time Frame
60 Days
Title
Date of engraftment
Time Frame
Date of engraftment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
patients undergoing allogeneic SCT with high risk of acute GVHD, ie. from matched unrelated donor or one HLA-locus mismatch sibling
Exclusion Criteria:
known allergy to mycophenolate mofetil
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Winnie WW Cheung, Dr
Phone
(852) 2855 3111
Email
cheungww@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence SY Ma, Dr
Organizational Affiliation
Department of Medicine/ Haematology and Oncology, Queen Mary Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
AKW Lie, Dr
First Name & Middle Initial & Last Name & Degree
WY Au, Dr
First Name & Middle Initial & Last Name & Degree
AYH Leung, Dr
First Name & Middle Initial & Last Name & Degree
Eric Tse, Dr
First Name & Middle Initial & Last Name & Degree
YL Kwong, Prof
First Name & Middle Initial & Last Name & Degree
Raymond Liang, Prof
12. IPD Sharing Statement
Learn more about this trial
Mycophenolate Mofetil for the Prophylaxis of Graft-versus-host Disease in High Risk Allogeneic Stem Cell Transplantation
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