Thymoglobulin in Unrelated Hematopoietic Progenitor Cell Transplantation

NCT01217723 | Unknown Phase 3 DMC

• 1 other identifier: CBMTG 0801
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 10

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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)

  12 months post transplant

Secondary Outcomes (1)

• Quality of Life

  Measured at Screening, Month 6, 12 and 24

Study Arms (2)

Thymoglobulin

EXPERIMENTAL

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

Biological: Anti-Thymocyte Globulin (Rabbit)

No Thymoglobulin

OTHER

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)

Interventions

Anti-Thymocyte Globulin (Rabbit) BIOLOGICAL

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.

Also known as: Thymoglobulin, ATGr, rabbit

Thymoglobulin

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

The standard preparative regimen can be myeloablative or reduced intensity.

No Thymoglobulin

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Genzyme, a Sanofi Company: collaborator
• The Canadian Blood and Marrow Transplant Group: collaborator

Study Sites (10)

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

RECRUITING

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 2YA, Canada

RECRUITING

Juravinski Hospital & Cancer Centre

Hamilton, Ontario, L8V 1C3, Canada

RECRUITING

Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

NOT YET RECRUITING

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

NOT YET RECRUITING

Hopital de l'Enfant Jesus

Montreal, Quebec, G1J 1Z4, Canada

NOT YET RECRUITING

Hopital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

RECRUITING

Royal Victoria Hospital

Montreal, Quebec, H3A 1A1, Canada

NOT YET RECRUITING

L'Hotel Dieu de Quebec

Québec, Quebec, G1R 2J6, Canada

NOT YET RECRUITING

Related Publications (3)

• Chakupurakal G, Freudenberger P, Skoetz N, Ahr H, Theurich S. Polyclonal anti-thymocyte globulins for the prophylaxis of graft-versus-host disease after allogeneic stem cell or bone marrow transplantation in adults. Cochrane Database Syst Rev. 2023 Jun 21;6(6):CD009159. doi: 10.1002/14651858.CD009159.pub3.

  PMID: 37341189 DERIVED

• 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.

  PMID: 31958417 DERIVED

• 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.

  PMID: 31756535 DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma; Myelodysplastic Syndromes; Myeloproliferative Disorders

Interventions

Antilymphocyte Serum; thymoglobulin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, B-Cell; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immune Sera; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Biological Products; Complex Mixtures

Study Officials

• Irwin Walker, MD

  McMaster University, Faculty of Health Sciences

  STUDY CHAIR

Central Study Contacts

Holly M Kerr, BA, BSN

CONTACT

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

Catherine L Singh

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 29, 2010
• First Posted: October 8, 2010
• Study Start: April 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: October 8, 2010

Record last verified: 2010-09

Locations

CA (10)