Thymoglobulin in Unrelated Hematopoietic Progenitor Cell Transplantation
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Purpose
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® as part of the preparative regimen prior to HPCT. The other 50% of the patients enrolled will receive a standard preparative regimen. Thymoglobulin is known to suppress the types of cells that can cause a transplant complication known as "chronic graft versus host disease (cGVHD)". The goal of this trial is to find out if adding Thymoglobulin to the preparative regimen will result in a decrease in cGVHD.
| Condition | Intervention | Phase |
|---|---|---|
|
Hematologic Malignancies |
Biological: Anti-Thymocyte Globulin (Rabbit) Other: Patients will receive a standard preparative regimen (i.e. one that does not contain Thymoglobulin) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Randomized Trial of Thymoglobulin to Prevent Chronic Graft Versus Host Disease in Patients Undergoing Hematopoietic Progenitor Cell Transplantation (HPCT) From Unrelated Donors |
- Freedom from Chronic GVHD [ Time Frame: 12 months post transplant ] [ Designated as safety issue: No ]"Freedom from Chronic GVHD" is defined as withdrawal of all systemic immunosuppressive agents and without resumption up to 12 months (a binary endpoint, yes/no)
- Quality of Life [ Time Frame: Measured at Screening, Month 6, 12 and 24 ] [ Designated as safety issue: No ]A series of questionnaires measured at the screening interval (up to 3 months prior to transplant), 6, 12 and 24 months post transplant.
| Estimated Enrollment: | 198 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Thymoglobulin
Thymoglobulin will be administered on Days -2, -1 prior to the transplant and on the day of transplant.
|
Biological: 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.
Other Names:
|
|
No Thymoglobulin
Patients will receive a standard preparative regimen. (i.e. one that does not normally contain Thymoglobulin.)
|
Other: 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.
|
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 transplants.
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.
Eligibility| Ages Eligible for Study: | 16 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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
Contacts and Locations| Contact: Holly M Kerr, BA, BSN | 604-875-4111 ext 63196 | hkerr@bccancer.bc.ca |
| Contact: Catherine L Singh | 604-875-411 ext 69013 | csingh@bccancer.bc.ca |
| Canada, British Columbia | |
| Vancouver General Hospital | Recruiting |
| Vancouver, British Columbia, Canada, V5Z 1M9 | |
| Contact: Holly M Kerr, BA, BSN 604-875-4111 ext 63196 hkerr@bccancer.bc.ca | |
| Contact: Catherine L Singh 604-875-4111 ext 69013 csingh@bccancer.bc.ca | |
| Principal Investigator: Thomas Nevill, MD | |
| Canada, Manitoba | |
| CancerCare Manitoba | Recruiting |
| Winnipeg, Manitoba, Canada, R3E 0V9 | |
| Contact: David Szwajcer, MD 204-787-4179 david.szwajcer@cancercare.mb.ca | |
| Canada, Nova Scotia | |
| Queen Elizabeth II Health Sciences Centre | Recruiting |
| Halifax, Nova Scotia, Canada, B3H 2YA | |
| Contact: Stephen Couban, MD 902-473-7006 stephen.couban@cdha.nshealth.ca | |
| Canada, Ontario | |
| Juravinski Hospital & Cancer Centre | Recruiting |
| Hamilton, Ontario, Canada, L8V 1C3 | |
| Contact: Irwin Walker, MD 905-521-2100 ext 76384 walkeri@mcmaster.ca | |
| Ottawa Hospital | Not yet recruiting |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Contact: Jason Tay, MD 613-737-8899 ext 73034 jtay@toh.on.ca | |
| Princess Margaret Hospital | Not yet recruiting |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Contact: John Kuruvilla, MD 416-946-4466 john.kuruvilla@uhn.on.ca | |
| Canada, Quebec | |
| Royal Victoria Hospital | Not yet recruiting |
| Montreal, Quebec, Canada, H3A 1A1 | |
| Contact: Gizelle Popradi, MD 514-934-1934 ext 31558 gizelle.propardi@muhc.mcgill.ca | |
| Hopital Maisonneuve-Rosemont | Recruiting |
| Montreal, Quebec, Canada, H1T 2M4 | |
| Contact: Jean Roy, MD 514-252-3400 ext 3404 jroy.hmr@ssss.gouv.qc.ca | |
| Hopital de l'Enfant Jesus | Not yet recruiting |
| Montreal, Quebec, Canada, G1J 1Z4 | |
| Contact: Genevieve Gallagher, MD 418-649-5727 genevieve.gallagher.cha@ssss.gouv.qc.ca | |
| L'Hotel Dieu de Quebec | Not yet recruiting |
| Quebec City, Quebec, Canada, G1R 2J6 | |
| Contact: Felix Couture, MD felixcou@videotron.ca | |
| Study Chair: | Irwin Walker, MD | McMaster University, Faculty of Health Sciences |
More Information
No publications provided
| Responsible Party: | Dr. Irwin Walker (Study Chair), McMaster University |
| ClinicalTrials.gov Identifier: | NCT01217723 History of Changes |
| Other Study ID Numbers: | CBMTG 0801 |
| Study First Received: | September 29, 2010 |
| Last Updated: | October 7, 2010 |
| Health Authority: | Canada: Health Canada United States: Institutional Review Board |
Keywords provided by McMaster University:
|
Acute leukemia (myeloid,lymphoid,or biphenotypic) Chronic myeloid leukemia Chronic lymphocytic leukemia |
Lymphoma Myelodysplastic syndrome Myeloproliferative disorder |
Additional relevant MeSH terms:
|
Neoplasms Graft vs Host Disease Hematologic Neoplasms Immune System Diseases Neoplasms by Site Hematologic Diseases |
Antilymphocyte Serum Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013