Thymoglobulin in Unrelated Hematopoietic Progenitor Cell Transplantation
NCT ID: NCT01217723
Last Updated: 2010-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
198 participants
INTERVENTIONAL
2010-04-30
2014-01-31
Brief Summary
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Detailed Description
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Intervention: Infusion of Thymoglobulin® on three days prior to the transplant.
Hypothesis: The hypothesis is that the use of Thymoglobulin® in the experimental group will result in an absolute 20% increase in the number of patients free of cGVHD at 12 months, the time of peak incidence, from 20% in the control group to 40% in the experimental group.
Outcome Measures: The Primary Outcome Measure is freedom from cGVHD at 12 months from transplantation, defined as withdrawal of all systemic immunosuppressive agents and without resumption up to 12 months (a binary end-point, yes/no). Secondary outcome measures: Quality of Life, overall incidence of cGVHD (including untreated cases and resolved cases), the incidence of "extensive" cGVHD, time to non-relapse mortality, time to all-cause mortality, time to relapse of leukemia, graft rejection or failure (Yes vs. No), serious infection (Yes vs. No), CMV activation (Yes vs. No), organ-specific grading of chronic graft versus host disease, resumption of immunosuppressive agents after 12 months (Yes vs. No), doses of immunosuppressive drugs still required at 12 months, and incidence of acute graft versus host disease.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Thymoglobulin
Thymoglobulin will be administered on Days -2, -1 prior to the transplant and on the day of transplant.
Anti-Thymocyte Globulin (Rabbit)
Thymoglobulin 0.5 mg/kg on Day -2 prior to the Transplant, 2.5 mg/kg on Day -1, and 2.5 mg/kg on the day of transplant.
No Thymoglobulin
Patients will receive a standard preparative regimen. (i.e. one that does not normally contain Thymoglobulin.)
Patients will receive a standard preparative regimen (i.e. one that does not contain Thymoglobulin)
The standard preparative regimen can be myeloablative or reduced intensity.
Interventions
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Anti-Thymocyte Globulin (Rabbit)
Thymoglobulin 0.5 mg/kg on Day -2 prior to the Transplant, 2.5 mg/kg on Day -1, and 2.5 mg/kg on the day of transplant.
Patients will receive a standard preparative regimen (i.e. one that does not contain Thymoglobulin)
The standard preparative regimen can be myeloablative or reduced intensity.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
16 Years
70 Years
ALL
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Genzyme, a Sanofi Company
INDUSTRY
The Canadian Blood and Marrow Transplant Group
NETWORK
McMaster University
OTHER
Responsible Party
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McMaster University
Principal Investigators
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Irwin Walker, MD
Role: STUDY_CHAIR
McMaster University, Faculty of Health Sciences
Locations
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Vancouver General Hospital
Vancouver, British Columbia, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
Juravinski Hospital & Cancer Centre
Hamilton, Ontario, Canada
Ottawa Hospital
Ottawa, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Hopital de l'Enfant Jesus
Montreal, Quebec, Canada
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Royal Victoria Hospital
Montreal, Quebec, Canada
L'Hotel Dieu de Quebec
Québec, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Chakupurakal G, Freudenberger P, Skoetz N, Ahr H, Theurich S. Polyclonal anti-thymocyte globulins for the prophylaxis of graft-versus-host disease after allogeneic stem cell or bone marrow transplantation in adults. Cochrane Database Syst Rev. 2023 Jun 21;6(6):CD009159. doi: 10.1002/14651858.CD009159.pub3.
Walker I, Panzarella T, Couban S, Couture F, Devins G, Elemary M, Gallagher G, Kerr H, Kuruvilla J, Lee SJ, Moore J, Nevill T, Popradi G, Roy J, Schultz KR, Szwajcer D, Toze C, Foley R; Cell Therapy Transplant Canada. Addition of anti-thymocyte globulin to standard graft-versus-host disease prophylaxis versus standard treatment alone in patients with haematological malignancies undergoing transplantation from unrelated donors: final analysis of a randomised, open-label, multicentre, phase 3 trial. Lancet Haematol. 2020 Feb;7(2):e100-e111. doi: 10.1016/S2352-3026(19)30220-0. Epub 2020 Jan 17.
Naeije L, Kariminia A, Abdossamadi S, Azadpour S, Subrt P, Kuzeljevic B, Irvine MA, Walker I, Schultz KR. Anti-Thymocyte Globulin Prophylaxis Induces a Decrease in Naive Th Cells to Inhibit the Onset of Chronic Graft-versus-Host Disease: Results from the Canadian Bone Marrow Transplant Group (CBMTG) 0801 Study. Biol Blood Marrow Transplant. 2020 Mar;26(3):438-444. doi: 10.1016/j.bbmt.2019.11.015. Epub 2019 Nov 19.
Other Identifiers
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CBMTG 0801
Identifier Type: -
Identifier Source: org_study_id