Status:
UNKNOWN
Thymoglobulin in Unrelated Hematopoietic Progenitor Cell Transplantation
Lead Sponsor:
McMaster University
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Genzyme, a Sanofi Company
Conditions:
Hematologic Malignancies
Eligibility:
All Genders
16-70 years
Phase:
PHASE3
Brief Summary
This is a randomized trial for patients undergoing hematopoietic progenitor cell transplantation (HPCT) from an unrelated donor. Approximately 50% of the patients enrolled will receive Thymoglobulin® ...
Detailed Description
This study is a non-blinded, randomized, multicentre trial testing the effect of Thymoglobulin® vs. placebo on the primary outcome of cGVHD. Subjects will be children and adults having unrelated donor...
Eligibility Criteria
Inclusion
- The recipient has a hematologic malignancy
- The recipient will receive one of the specified preparative regimens
- The recipient will receive either a bone marrow ("HPC, Marrow") or blood progenitor cell ("HPC, Apheresis") graft
- The recipient has an unrelated donor who with high resolution typing is either fully MHC matched at HLA-A, B, C and DRB1 with the recipient or is 1-antigen or 1-allele mismatched at A, B, C or DRB1 loci The recipient meets the transplant centre's criteria for unrelated donor allogeneic transplantation , either myeloablative or non-myeloablative (syn. RIC).
- The recipient has good performance status (Karnofsky ≥60%)
- Recipient has given signed informed consent For the questionnaire component only, be able to complete the questionnaires in English or with a validated translation (as posted on the project website)
Exclusion
- The recipient is HIV antibody positive
- The recipient has a hypersensitivity to rabbit proteins or Thymoglobulin pharmaceutical excipients, glycine or mannitol
- The recipient has active or chronic infection (i.e. infection requiring oral or IV therapy)
- The recipient (if female and of childbearing potential) is pregnant or breast-feeding at the time of enrollment
- The recipient (if female and of childbearing potential) does not agree to use an adequate contraceptive method from the time of enrollment until a minimum of one year following transplant
- The recipient (if male and fertile) does not agree to use an adequate contraceptive method from the time of enrollment until a minimum of one year following transplant
- For the questionnaire component only, the recipient is unable to participate due to cognitive, linguistic or emotional difficulties (i.e. the recipient can participate in the main study but will be excluded from the questionnaire component
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2014
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT01217723
Start Date
April 1 2010
End Date
January 1 2014
Last Update
October 8 2010
Active Locations (10)
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1
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
2
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
3
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 2YA
4
Juravinski Hospital & Cancer Centre
Hamilton, Ontario, Canada, L8V 1C3