Mycophenolate Mofetil for the Prophylaxis of Graft-versus-host Disease in High Risk Allogeneic Stem Cell Transplantation
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Hospital Authority, Hong Kong.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Hospital Authority, Hong Kong
Collaborator:
Hoffmann-La Roche
Information provided by:
Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:
NCT00563589
First received: November 21, 2007
Last updated: July 6, 2010
Last verified: July 2010
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Graft vs Host Disease Hematopoietic Stem Cell Transplantation |
Drug: mycophenolate mofetil, methotrexate, cyclosporin Drug: Methotrexate and cyclosporin |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
Drug Information available for:
Methotrexate
Methotrexate sodium
Mycophenolic acid
Mycophenolate sodium
Cyclosporine
Mycophenolate mofetil hydrochloride
Mycophenolate mofetil
U.S. FDA Resources
Further study details as provided by Hospital Authority, Hong Kong:
Primary Outcome Measures:
- acute GVHD incidence and grading [ Time Frame: 100 Days ]
- chronic GVHD incidence [ Time Frame: 3 Years ]
Secondary Outcome Measures:
- Mortality, GVHD-related and all cause [ Time Frame: 3 Years ]
- Symptomatic side effects attributed to MMF [ Time Frame: 60 Days ]
- Date of engraftment [ Time Frame: Date of engraftment ]
| Estimated Enrollment: | 30 |
| Study Start Date: | August 2003 |
| Estimated Study Completion Date: | December 2008 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00563589
Contacts
| Contact: Winnie WW Cheung, Dr | (852) 2855 3111 | cheungww@hotmail.com |
Locations
| China | |
| Queen Mary Hospital | Recruiting |
| Hong Kong, China | |
| Sub-Investigator: AKW Lie, Dr | |
| Sub-Investigator: WY Au, Dr | |
| Sub-Investigator: AYH Leung, Dr | |
| Sub-Investigator: Eric Tse, Dr | |
| Sub-Investigator: YL Kwong, Prof | |
| Sub-Investigator: Raymond Liang, Prof | |
Sponsors and Collaborators
Hospital Authority, Hong Kong
Hoffmann-La Roche
Investigators
| Principal Investigator: | Lawrence SY Ma, Dr | Department of Medicine/ Haematology and Oncology, Queen Mary Hospital |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00563589 History of Changes |
| Other Study ID Numbers: | IRB 03-09 R/353, HARECCTR0500036 |
| Study First Received: | November 21, 2007 |
| Last Updated: | July 6, 2010 |
| Health Authority: | Hong Kong: Ethics Committee |
Keywords provided by Hospital Authority, Hong Kong:
|
Acute graft-versus-host disease post high risk allogeneic stem cell transplantation |
Additional relevant MeSH terms:
|
Graft vs Host Disease Immune System Diseases Cyclosporins Cyclosporine Methotrexate Mycophenolic Acid Mycophenolate mofetil Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antifungal Agents |
Anti-Infective Agents Therapeutic Uses Dermatologic Agents Antirheumatic Agents Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Antimetabolites, Antineoplastic Antimetabolites Antineoplastic Agents Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors Antibiotics, Antineoplastic |
ClinicalTrials.gov processed this record on May 22, 2013