Mycophenolate Mofetil for the Prophylaxis of Graft-versus-host Disease in High Risk Allogeneic Stem Cell Transplantation

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. Read our disclaimer for details. Identifier: NCT00563589
Recruitment Status : Unknown
Verified July 2010 by Hospital Authority, Hong Kong.
Recruitment status was:  Recruiting
First Posted : November 26, 2007
Last Update Posted : July 7, 2010
Hoffmann-La Roche
Information provided by:
Hospital Authority, Hong Kong

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.

Condition or disease Intervention/treatment Phase
Graft vs Host Disease Hematopoietic Stem Cell Transplantation Drug: mycophenolate mofetil, methotrexate, cyclosporin Drug: Methotrexate and cyclosporin Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2003
Estimated Study Completion Date : December 2008

Primary Outcome Measures :
  1. acute GVHD incidence and grading [ Time Frame: 100 Days ]
  2. chronic GVHD incidence [ Time Frame: 3 Years ]

Secondary Outcome Measures :
  1. Mortality, GVHD-related and all cause [ Time Frame: 3 Years ]
  2. Symptomatic side effects attributed to MMF [ Time Frame: 60 Days ]
  3. Date of engraftment [ Time Frame: Date of engraftment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

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

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 identifier (NCT number): NCT00563589

Contact: Winnie WW Cheung, Dr (852) 2855 3111

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
Principal Investigator: Lawrence SY Ma, Dr Department of Medicine/ Haematology and Oncology, Queen Mary Hospital

Additional Information: Identifier: NCT00563589     History of Changes
Other Study ID Numbers: IRB 03-09 R/353
First Posted: November 26, 2007    Key Record Dates
Last Update Posted: July 7, 2010
Last Verified: July 2010

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
Mycophenolic Acid
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Antifungal Agents
Anti-Infective Agents
Calcineurin Inhibitors
Antibiotics, Antineoplastic
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents