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Thymoglobulin in Unrelated Hematopoietic Progenitor Cell Transplantation

Primary Purpose

Hematologic Malignancies

Status
Unknown status
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Anti-Thymocyte Globulin (Rabbit)
Patients will receive a standard preparative regimen (i.e. one that does not contain Thymoglobulin)
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hematologic Malignancies focused on measuring Acute leukemia (myeloid,lymphoid,or biphenotypic), Chronic myeloid leukemia, Chronic lymphocytic leukemia, Lymphoma, Myelodysplastic syndrome, Myeloproliferative disorder

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vancouver General HospitalRecruiting
  • CancerCare ManitobaRecruiting
  • Queen Elizabeth II Health Sciences CentreRecruiting
  • Juravinski Hospital & Cancer CentreRecruiting
  • Ottawa Hospital
  • Princess Margaret Hospital
  • Hopital de l'Enfant Jesus
  • Hopital Maisonneuve-RosemontRecruiting
  • Royal Victoria Hospital
  • L'Hotel Dieu de Quebec

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Thymoglobulin

No Thymoglobulin

Arm Description

Thymoglobulin will be administered on Days -2, -1 prior to the transplant and on the day of transplant.

Patients will receive a standard preparative regimen. (i.e. one that does not normally contain Thymoglobulin.)

Outcomes

Primary Outcome Measures

Freedom from Chronic GVHD
"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
A series of questionnaires measured at the screening interval (up to 3 months prior to transplant), 6, 12 and 24 months post transplant.

Full Information

First Posted
September 29, 2010
Last Updated
October 7, 2010
Sponsor
McMaster University
Collaborators
Canadian Institutes of Health Research (CIHR), Genzyme, a Sanofi Company, The Canadian Blood and Marrow Transplant Group
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1. Study Identification

Unique Protocol Identification Number
NCT01217723
Brief Title
Thymoglobulin in Unrelated Hematopoietic Progenitor Cell Transplantation
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 Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
January 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
McMaster University
Collaborators
Canadian Institutes of Health Research (CIHR), Genzyme, a Sanofi Company, The Canadian Blood and Marrow Transplant Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Malignancies
Keywords
Acute leukemia (myeloid,lymphoid,or biphenotypic), Chronic myeloid leukemia, Chronic lymphocytic leukemia, Lymphoma, Myelodysplastic syndrome, Myeloproliferative disorder

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
198 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Thymoglobulin
Arm Type
Experimental
Arm Description
Thymoglobulin will be administered on Days -2, -1 prior to the transplant and on the day of transplant.
Arm Title
No Thymoglobulin
Arm Type
Other
Arm Description
Patients will receive a standard preparative regimen. (i.e. one that does not normally contain Thymoglobulin.)
Intervention Type
Biological
Intervention Name(s)
Anti-Thymocyte Globulin (Rabbit)
Other Intervention Name(s)
Thymoglobulin, ATGr, rabbit
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Patients will receive a standard preparative regimen (i.e. one that does not contain Thymoglobulin)
Intervention Description
The standard preparative regimen can be myeloablative or reduced intensity.
Primary Outcome Measure Information:
Title
Freedom from Chronic GVHD
Description
"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)
Time Frame
12 months post transplant
Secondary Outcome Measure Information:
Title
Quality of Life
Description
A series of questionnaires measured at the screening interval (up to 3 months prior to transplant), 6, 12 and 24 months post transplant.
Time Frame
Measured at Screening, Month 6, 12 and 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Holly M Kerr, BA, BSN
Phone
604-875-4111
Ext
63196
Email
hkerr@bccancer.bc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine L Singh
Phone
604-875-411
Ext
69013
Email
csingh@bccancer.bc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irwin Walker, MD
Organizational Affiliation
McMaster University, Faculty of Health Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Holly M Kerr, BA, BSN
Phone
604-875-4111
Ext
63196
Email
hkerr@bccancer.bc.ca
First Name & Middle Initial & Last Name & Degree
Catherine L Singh
Phone
604-875-4111
Ext
69013
Email
csingh@bccancer.bc.ca
First Name & Middle Initial & Last Name & Degree
Thomas Nevill, MD
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Szwajcer, MD
Phone
204-787-4179
Email
david.szwajcer@cancercare.mb.ca
Facility Name
Queen Elizabeth II Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2YA
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Couban, MD
Phone
902-473-7006
Email
stephen.couban@cdha.nshealth.ca
Facility Name
Juravinski Hospital & Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irwin Walker, MD
Phone
905-521-2100
Ext
76384
Email
walkeri@mcmaster.ca
Facility Name
Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Tay, MD
Phone
613-737-8899
Ext
73034
Email
jtay@toh.on.ca
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Kuruvilla, MD
Phone
416-946-4466
Email
john.kuruvilla@uhn.on.ca
Facility Name
Hopital de l'Enfant Jesus
City
Montreal
State/Province
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Genevieve Gallagher, MD
Phone
418-649-5727
Email
genevieve.gallagher.cha@ssss.gouv.qc.ca
Facility Name
Hopital Maisonneuve-Rosemont
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Roy, MD
Phone
514-252-3400
Ext
3404
Email
jroy.hmr@ssss.gouv.qc.ca
Facility Name
Royal Victoria Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gizelle Popradi, MD
Phone
514-934-1934
Ext
31558
Email
gizelle.propardi@muhc.mcgill.ca
Facility Name
L'Hotel Dieu de Quebec
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felix Couture, MD
Email
felixcou@videotron.ca

12. IPD Sharing Statement

Citations:
PubMed Identifier
31958417
Citation
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. Erratum In: Lancet Haematol. 2020 Jan 29;:
Results Reference
derived
PubMed Identifier
31756535
Citation
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.
Results Reference
derived

Learn more about this trial

Thymoglobulin in Unrelated Hematopoietic Progenitor Cell Transplantation

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