Alemtuzumab and Cyclosporine for the Prevention of Graft vs Host Disease After Stem Cell Transplants

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: NCT00775632
Recruitment Status : Completed
First Posted : October 20, 2008
Last Update Posted : June 23, 2016
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:

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:

  • To find if by lowering the dose of alemtuzumab, can serious GVHD be prevented without increasing the risk of relapse (your condition getting worse).
  • To find whether low dose of alemtuzumab in combination with cyclosporine can prevent GVHD more effectively when compared to current standard of care and does not increase the risk of recurrence.

Condition or disease Intervention/treatment Phase
Graft Versus Host Disease Bone Marrow Transplantation Drug: Alemtuzumab Drug: mycophenolate or cyclosporine and methotrexate Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : October 2008
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Standard of Care
The current standard of care for GVHD prophylaxis at Princess Margaret Hospital is cyclosporine and Mycophenolate or cyclosporine and methotrexate.
Drug: mycophenolate or cyclosporine and methotrexate
One of the two GVHD prophylaxis used at PMH-either cyclosporine and mycophenolate or cyclosporine and methotrexate

Experimental: Cyclosporine and Campath
The efficacy of experimental arm will be tested against standard of care for prevention of Chronic extensive GVHD.
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.

Primary Outcome Measures :
  1. Chronic extensive GVHD at 1-year (yes vs. no) [ Time Frame: 12 months from the date of transplant ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of a hematological malignancy
  • Peripheral blood as source of stem cells
  • Able to give informed consent
  • Availability of 6/6 matched sibling donor
  • Fit for transplant using a conventional or reduced intensity approach

Exclusion Criteria:

  • AST/ALT >3 x IULN at the time of transplant
  • Serum creatinine > 1.5 x IULN at the time of transplant
  • Prior allogeneic transplant
  • Syngeneic donor
  • Active uncontrolled infection
  • HIV positive
  • Pregnancy at the time of BMT

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): NCT00775632

Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Principal Investigator: Vikas Gupta, MD University Heath Network

Responsible Party: University Health Network, Toronto Identifier: NCT00775632     History of Changes
Other Study ID Numbers: UHN REB 07-0436C
First Posted: October 20, 2008    Key Record Dates
Last Update Posted: June 23, 2016
Last Verified: June 2016

Keywords provided by University Health Network, Toronto:
Graft Versus Host Disease
Bone Marrow Transplants

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