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

NCT ID: NCT00775632

Last Updated: 2016-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2010-09-30

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.

Conditions

Graft Versus Host Disease; Bone Marrow Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of Care

The current standard of care for GVHD prophylaxis at Princess Margaret Hospital is cyclosporine and Mycophenolate or cyclosporine and methotrexate.

Group Type: ACTIVE_COMPARATOR

mycophenolate or cyclosporine and methotrexate

Intervention Type: DRUG

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

Cyclosporine and Campath

The efficacy of experimental arm will be tested against standard of care for prevention of Chronic extensive GVHD.

Group Type: EXPERIMENTAL

Alemtuzumab

Intervention Type: DRUG

A new GVHD prevention strategy will be tested against established GVHD prophylaxis in patients undergoing matched sibling donor transplant using peripheral blood stem cells.

Interventions

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.

Intervention Type: DRUG

mycophenolate or cyclosporine and methotrexate

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vikas Gupta, MD

Role: PRINCIPAL_INVESTIGATOR

University Heath Network

Locations

Princess Margaret Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

UHN REB 07-0436C

Identifier Type: -

Identifier Source: org_study_id