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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Chronic extensive GVHD at 1-year (yes vs. no)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to 70 Years (Child, Adult, Older Adult)
- Sex
- 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
Arms & Interventions
Standard of Care
The current standard of care for GVHD prophylaxis at Princess Margaret Hospital is cyclosporine and Mycophenolate or cyclosporine and methotrexate.
Intervention: mycophenolate or cyclosporine and methotrexate (Drug)
Cyclosporine and Campath
The efficacy of experimental arm will be tested against standard of care for prevention of Chronic extensive GVHD.
Intervention: Alemtuzumab (Drug)
Outcomes
Primary Outcomes
Chronic extensive GVHD at 1-year (yes vs. no)
Time Frame: 12 months from the date of transplant
Secondary Outcomes
No secondary outcomes reported