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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Bayer
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00775632
First received: October 16, 2008
Last updated: October 17, 2008
Last verified: October 2008
  Purpose

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.

Condition Intervention Phase
Graft Versus Host Disease
Bone Marrow Transplantation
Drug: Alemtuzumab
Drug: mycophenolate or cyclosporine and methotrexate
Phase 2

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

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Chronic extensive GVHD at 1-year (yes vs. no) [ Time Frame: 12 months from the date of transplant ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 78
Study Start Date: October 2008
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard of Care
The current standard of care for GVHD prophylaxis at Princess Margaret Hospital is cyclosporine and Mycophenolate or cyclosporine and methotrexate.
Drug: mycophenolate or cyclosporine and methotrexate
One of the two GVHD prophylaxis used at PMH-either cyclosporine and mycophenolate or cyclosporine and methotrexate
Experimental: Cyclosporine and Campath
The efficacy of experimental arm will be tested against standard of care for prevention of Chronic extensive GVHD.
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.

  Eligibility

Ages Eligible for Study:   16 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00775632

Contacts
Contact: Vikas Gupta 416-946-4521 vikas.gupta@uhn.on.ca

Locations
Canada, Ontario
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Bayer
Investigators
Principal Investigator: Vikas Gupta, MD University Heath Network
  More Information

No publications provided

Responsible Party: Dr. Vikas Gupta, University Health Network
ClinicalTrials.gov Identifier: NCT00775632     History of Changes
Other Study ID Numbers: UHN REB 07-0436C
Study First Received: October 16, 2008
Last Updated: October 17, 2008
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
Graft Versus Host Disease
Alemtuzumab
Campath
Bone Marrow Transplants

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Alemtuzumab
Cyclosporine
Cyclosporins
Methotrexate
Mycophenolate mofetil
Mycophenolic Acid
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014