Thymoglobulin in Unrelated Hematopoietic Progenitor Cell Transplantation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01217723|
Recruitment Status : Unknown
Verified September 2010 by McMaster University.
Recruitment status was: Recruiting
First Posted : October 8, 2010
Last Update Posted : October 8, 2010
|Condition or disease||Intervention/treatment||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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||198 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2010|
|Estimated Primary Completion Date :||January 2014|
|Estimated Study Completion Date :||January 2014|
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.
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.
- Freedom from Chronic GVHD [ Time Frame: 12 months post transplant ]"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 ]A series of questionnaires measured at the screening interval (up to 3 months prior to transplant), 6, 12 and 24 months post transplant.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01217723
|Contact: Holly M Kerr, BA, BSN||604-875-4111 ext firstname.lastname@example.org|
|Contact: Catherine L Singh||604-875-411 ext email@example.com|
|Canada, British Columbia|
|Vancouver General Hospital||Recruiting|
|Vancouver, British Columbia, Canada, V5Z 1M9|
|Contact: Holly M Kerr, BA, BSN 604-875-4111 ext 63196 firstname.lastname@example.org|
|Contact: Catherine L Singh 604-875-4111 ext 69013 email@example.com|
|Principal Investigator: Thomas Nevill, MD|
|Winnipeg, Manitoba, Canada, R3E 0V9|
|Contact: David Szwajcer, MD 204-787-4179 firstname.lastname@example.org|
|Canada, Nova Scotia|
|Queen Elizabeth II Health Sciences Centre||Recruiting|
|Halifax, Nova Scotia, Canada, B3H 2YA|
|Contact: Stephen Couban, MD 902-473-7006 email@example.com|
|Juravinski Hospital & Cancer Centre||Recruiting|
|Hamilton, Ontario, Canada, L8V 1C3|
|Contact: Irwin Walker, MD 905-521-2100 ext 76384 firstname.lastname@example.org|
|Ottawa Hospital||Not yet recruiting|
|Ottawa, Ontario, Canada, K1H 8L6|
|Contact: Jason Tay, MD 613-737-8899 ext 73034 email@example.com|
|Princess Margaret Hospital||Not yet recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Contact: John Kuruvilla, MD 416-946-4466 firstname.lastname@example.org|
|Hopital de l'Enfant Jesus||Not yet recruiting|
|Montreal, Quebec, Canada, G1J 1Z4|
|Contact: Genevieve Gallagher, MD 418-649-5727 email@example.com|
|Montreal, Quebec, Canada, H1T 2M4|
|Contact: Jean Roy, MD 514-252-3400 ext 3404 firstname.lastname@example.org|
|Royal Victoria Hospital||Not yet recruiting|
|Montreal, Quebec, Canada, H3A 1A1|
|Contact: Gizelle Popradi, MD 514-934-1934 ext 31558 email@example.com|
|L'Hotel Dieu de Quebec||Not yet recruiting|
|Quebec City, Quebec, Canada, G1R 2J6|
|Contact: Felix Couture, MD firstname.lastname@example.org|
|Study Chair:||Irwin Walker, MD||McMaster University, Faculty of Health Sciences|