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Sponsors and Collaborators: |
University Health Network, Toronto Bayer |
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Information provided by: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT00775632 |
Graft versus host disease (GVHD) is one of the common complications after stem cell transplant. This is a complication, which happens when the new stem cells from the donor attack other cells in the body of the transplant recipient.
Recently, an antibody (protein) called alemtuzumab or Campath has been found to be effective in the prevention of Graft vs. Host Disease.
Previous studies have shown a low risk of GVHD with alemtuzumab, however the risk of disease recurrence was high. Previous studies have used a high dose of alemtuzumab. The purpose of this study is:
Condition | Intervention | Phase |
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Graft Versus Host Disease Bone Marrow Transplantation |
Drug: Alemtuzumab Drug: mycophenolate or cyclosporine and methotrexate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Randomized Study Comparing Low Dose Alemtuzumab and Cyclosporine With Standard of Care for the Prevention of Chronic Extensive GVHD for Patients Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation (PBSCT) for Hematological Malignancies |
Estimated Enrollment: | 78 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | September 2012 |
Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Standard of Care: Active Comparator
The current standard of care for GVHD prophylaxis at Princess Margaret Hospital is cyclosporine and Mycophenolate or cyclosporine and methotrexate.
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Drug: mycophenolate or cyclosporine and methotrexate
One of the two GVHD prophylaxis used at PMH-either cyclosporine and mycophenolate or cyclosporine and methotrexate
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Cyclosporine and Campath: Experimental
The efficacy of experimental arm will be tested against standard of care for prevention of Chronic extensive GVHD.
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Drug: Alemtuzumab
A new GVHD prevention strategy will be tested against established GVHD prophylaxis in patients undergoing matched sibling donor transplant using peripheral blood stem cells.
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Ages Eligible for Study: | 16 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Vikas Gupta | 416-946-4521 | vikas.gupta@uhn.on.ca |
Canada, Ontario | |
Princess Margaret Hospital | Recruiting |
Toronto, Ontario, Canada, M5G 2M9 |
Principal Investigator: | Vikas Gupta, MD | University Heath Network |
Responsible Party: | University Health Network ( Dr. Vikas Gupta ) |
Study ID Numbers: | UHN REB 07-0436C |
Study First Received: | October 16, 2008 |
Last Updated: | October 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00775632 |
Health Authority: | Canada: Health Canada |
Graft Versus Host Disease Alemtuzumab Campath Bone Marrow Transplants |
Folic Acid Cyclosporine Clotrimazole Graft versus host disease Miconazole Alemtuzumab |
Tioconazole Mycophenolate mofetil Methotrexate Graft vs Host Disease Cyclosporins Homologous wasting disease |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immune System Diseases Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Reproductive Control Agents |
Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Pharmacologic Actions Antifungal Agents Therapeutic Uses Abortifacient Agents Antirheumatic Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors |