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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Graft Versus Host Disease, Bone Marrow Transplantation

Intervention / Treatment
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* Drug: Alemtuzumab
* Drug: mycophenolate or cyclosporine and methotrexate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care<br>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<br>* One of the two GVHD prophylaxis used at PMH-either cyclosporine and mycophenolate or cyclosporine and methotrexate<br>|
| Experimental: Cyclosporine and Campath<br>The efficacy of experimental arm will be tested against standard of care for prevention of Chronic extensive GVHD. | Drug: Alemtuzumab<br>* A new GVHD prevention strategy will be tested against established GVHD prophylaxis in patients undergoing matched sibling donor transplant using peripheral blood stem cells.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic extensive GVHD at 1-year (yes vs. no) |  | 12 months from the date of transplant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Graft Versus Host Disease, Alemtuzumab, Campath, Bone Marrow Transplants