Recruiting
Phase 3

Thymoglobulin

Sponsor:

McMaster University

Code:

NCT01217723

Conditions

Hematologic Malignancies

Eligibility Criteria

Sex: All

Age: 16 - 70

Healthy Volunteers: Not accepted

Interventions

Anti-Thymocyte Globulin (Rabbit)

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

Study Details

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.

Conditions

Hematologic Malignancies

Study ID

NCT01217723

Start date

Apr, 2010

Status verified date

Sep, 2010

Completion date

Jan, 2014

Anticipated

Primary completion date

Jan, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 70

Healthy Volunteers: Not accepted

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 Design

Enrollment

198 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Thymoglobulin

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

other: No Thymoglobulin

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

Interventions

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 contain Thymoglobulin)

The standard preparative regimen can be myeloablative or reduced intensity.

Primary outcome measure

  • Freedom from Chronic GVHD [ Time Frame: 12 months post transplant ]

Central Contacts and Locations

Central contacts

Holly M Kerr, BA, BSN

604-875-4111hkerr@bccancer.bc.ca

Catherine L Singh

604-875-411csingh@bccancer.bc.ca

Locations

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Contacts

Holly M Kerr, BA, BSN

604-875-4111hkerr@bccancer.bc.ca

Catherine L Singh

604-875-4111csingh@bccancer.bc.ca

Principal Investigator:

Thomas Nevill, MD

CancerCare Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3E 0V9

Contacts

David Szwajcer, MD

204-787-4179david.szwajcer@cancercare.mb.ca

Queen Elizabeth II Health Sciences Centre

Recruiting

Halifax, Nova Scotia, Canada, B3H 2YA

Contacts

Stephen Couban, MD

902-473-7006stephen.couban@cdha.nshealth.ca

Juravinski Hospital & Cancer Centre

Recruiting

Hamilton, Ontario, Canada, L8V 1C3

Contacts

Irwin Walker, MD

905-521-2100walkeri@mcmaster.ca

Hopital Maisonneuve-Rosemont

Recruiting

Montreal, Quebec, Canada, H1T 2M4

Contacts

Jean Roy, MD

514-252-3400jroy.hmr@ssss.gouv.qc.ca

More Information

Sponsor

McMaster University

Last update posted

Oct 8, 2010

Last verified

Sep, 2010

Keywords

  • Acute leukemia (myeloid,lymphoid,or biphenotypic)
  • Chronic myeloid leukemia
  • Chronic lymphocytic leukemia
  • Lymphoma
  • Myelodysplastic syndrome
  • Myeloproliferative disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2010-10-08.