Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Chronic extensive GVHD at 1-year (yes vs. no)
Outcome Time Frame:
12 months from the date of transplant
Safety Issue:
Yes
Principal Investigator
Vikas Gupta, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Heath Network
Authority:
Canada: Health Canada
Study ID:
UHN REB 07-0436C
NCT ID:
NCT00775632
Start Date:
October 2008
Completion Date:
September 2012
Related Keywords:
- Graft Versus Host Disease
- Bone Marrow Transplantation
- Graft Versus Host Disease
- Alemtuzumab
- Campath
- Bone Marrow Transplants
- Graft vs Host Disease