Thymoglobulin in Unrelated Hematopoietic Progenitor Cell Transplantation

October 7, 2010 updated by: McMaster University

A Randomized Trial of Thymoglobulin to Prevent Chronic Graft Versus Host Disease in Patients Undergoing Hematopoietic Progenitor Cell Transplantation (HPCT) From Unrelated Donors

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

198

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Recruiting
        • Vancouver General Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Thomas Nevill, MD
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2YA
    • Ontario
      • Hamilton, Ontario, Canada, L8V 1C3
        • Recruiting
        • Juravinski Hospital & Cancer Centre
        • Contact:
      • Ottawa, Ontario, Canada, K1H 8L6
        • Not yet recruiting
        • Ottawa Hospital
        • Contact:
          • Jason Tay, MD
          • Phone Number: 73034 613-737-8899
          • Email: jtay@toh.on.ca
      • Toronto, Ontario, Canada, M5G 2M9
        • Not yet recruiting
        • Princess Margaret Hospital
        • Contact:
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Recruiting
        • Hôpital Maisonneuve-Rosemont
        • Contact:
      • Montreal, Quebec, Canada, G1J 1Z4
      • Montreal, Quebec, Canada, H3A 1A1
      • Quebec City, Quebec, Canada, G1R 2J6

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
12 months post transplant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measured at Screening, Month 6, 12 and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Anticipated)

January 1, 2014

Study Completion (Anticipated)

January 1, 2014

Study Registration Dates

First Submitted

September 29, 2010

First Submitted That Met QC Criteria

October 7, 2010

First Posted (Estimate)

October 8, 2010

Study Record Updates

Last Update Posted (Estimate)

October 8, 2010

Last Update Submitted That Met QC Criteria

October 7, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBMTG 0801

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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