Thymoglobulin to prevent chronic graft versus host disease in hematopoietic progenitor cell transplantation patients

Phase 3

Completed

• Conditions: Chronic graft versus host disease; Injury, Occupational Diseases, Poisoning; Failure and rejection of transplanted organs and tissues

• Registration Number: ISRCTN29899028
• Lead Sponsor: McMaster University (Canada)

Brief Summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26723083 2020 results in https://www.ncbi.nlm.nih.gov/pubmed/31958417 (added 21/01/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-02-23
• Study Completion: 2015-12-01
• Last Update Posted: 3 February 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 203

Inclusion Criteria

1. The recipient is aged between 16 and 70 years, either sex
2. The recipient has an haematologic malignancy i.e. one of:
2.1. Acute leukaemia, myeloid, lymphoid, or biphenotypic, in 1st or 2nd remission or be in early relapse (no chemotherapy within three months and blasts less than 10% and with previous remission having been longer than 3 months)
2.2. Chronic myeloid leukaemia, in chronic or stable accelerated phase
2.3. Chronic lymphocytic leukaemia
2.4. Lymphoma
2.5. Myelodysplastic syndrome
2.6. Myeloproliferative disorder
3. The recipient will receive one of the specified preparative regimens
4. The recipient will receive either a bone marrow (HPC, Marrow) or blood progenitor cell (HPC, Apheresis) graft
5. 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
6. The recipient meets the transplant centre's criteria for unrelated donor allogeneic transplantation, either myeloablative or non-myeloablative (syn. RIC)
7. The recipient has good performance status (Karnofsky greater than or equal to 60%)
8. Recipient has given signed informed consent
9. For the questionnaire component only, be able to complete the questionnaires in English or with a validated translation

Exclusion Criteria

1. The recipient is human immunodeficiency virus (HIV) antibody positive
2. The recipient has a hypersensitivity to rabbit proteins or thymoglobulin pharmaceutical excipients, glycine or mannitol
3. The recipient has an active infection (i.e. infection requiring oral or intravenous [IV] therapy)
4. The recipient (if female and of childbearing potential) is pregnant or breast-feeding at the time of enrolment
5. The recipient (if female and of childbearing potential) does not agree to use an adequage contraceptive method from the time of enrolment until a minimum of one year following transplant
6. The recipient (if male and fertile) does not agree to use an adequate contraceptive method from the time of enrolment until a minimum of one year following transplant
7. 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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Freedom of cGVHD at 12 months from transplantation defined as withdrawal of all systemic immunosuppressive agents without resumption up to 12 months after transplantation.