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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
Sponsor:
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
  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:


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
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, see Learn About Clinical Studies.

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
Cyclosporine
Cyclosporins
Methotrexate
Mycophenolate mofetil
Mycophenolic Acid
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014