Thymoglobulin in Unrelated Hematopoietic Progenitor Cell Transplantation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by McMaster University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Genzyme, a Sanofi Company
The Canadian Blood and Marrow Transplant Group
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT01217723
First received: September 29, 2010
Last updated: October 7, 2010
Last verified: September 2010
  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

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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:
  • Thymoglobulin
  • ATGr
  • rabbit
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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01217723

Contacts
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

Locations
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   
Sponsors and Collaborators
McMaster University
Canadian Institutes of Health Research (CIHR)
Genzyme, a Sanofi Company
The Canadian Blood and Marrow Transplant Group
Investigators
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
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases
Antilymphocyte Serum
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014