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

Graft Versus Host Disease Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00775632
Study type Interventional
Source University Health Network, Toronto
Contact
Status Completed
Phase Phase 2
Start date October 2008
Completion date September 2010
View Details
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