Alemtuzumab and Cyclosporine for the Prevention of Graft vs Host Disease After Stem Cell Transplants - Full Text View

Sponsors and Collaborators:	University Health Network, Toronto Bayer
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00775632

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 II

MedlinePlus related topics: Bone Marrow Transplantation

Drug Information available for: Methotrexate Cyclosporin Cyclosporine Alemtuzumab Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Campath

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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
Standard of Care: Active Comparator 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
Cyclosporine and Campath: Experimental 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

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

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

Keywords provided by University Health Network, Toronto:

Graft Versus Host Disease
Alemtuzumab
Campath
Bone Marrow Transplants

Study placed in the following topic categories:

Folic Acid
Cyclosporine
Clotrimazole
Graft versus host disease
Miconazole
Alemtuzumab

Tioconazole
Mycophenolate mofetil
Methotrexate
Graft vs Host Disease
Cyclosporins
Homologous wasting disease

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Reproductive Control Agents

Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Antifungal Agents
Therapeutic Uses
Abortifacient Agents
Antirheumatic Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009