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

Phase 2

Completed

• Conditions: Graft Versus Host Disease; Bone Marrow Transplantation
• Interventions: Drug: mycophenolate or cyclosporine and methotrexate; Drug: Alemtuzumab

• Registration Number: NCT00775632
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-16
• Study First Submitted QC: 2008-10-17
• Study First Posted: 2008-10-20
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-21
• Last Update Posted: 2016-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	mycophenolate or cyclosporine and methotrexate	The current standard of care for GVHD prophylaxis at Princess Margaret Hospital is cyclosporine and Mycophenolate or cyclosporine and methotrexate.
Cyclosporine and Campath	Alemtuzumab	The efficacy of experimental arm will be tested against standard of care for prevention of Chronic extensive GVHD.

Primary Outcome Measures

Name	Time	Method
Chronic extensive GVHD at 1-year (yes vs. no)	12 months from the date of transplant

Trial Locations

Locations (1)

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada