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 Details — Status: Completed

Administrative data

• NCT number: NCT00775632
• Other study ID #: UHN REB 07-0436C
• Status: Completed
• Phase: Phase 2
• First received: October 16, 2008
• Last updated: June 21, 2016
• Start date: October 2008
• Est. completion date: September 2010

Study information

• Verified date: June 2016
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Bone Marrow Transplantation
• Graft Versus Host Disease
• Graft vs Host Disease

Intervention

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.
• mycophenolate or cyclosporine and methotrexate
One of the two GVHD prophylaxis used at PMH-either cyclosporine and mycophenolate or cyclosporine and methotrexate

Locations

Country	Name	City	State
Canada	Princess Margaret Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Bayer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic extensive GVHD at 1-year (yes vs. no)		12 months from the date of transplant	Yes