Chronic graft versus host disease Injury, Occupational Diseases, Poisoning Failure and rejection of transplanted organs and tissues
Conditions
Interventions
This is a randomised trial. Patients randomised to the thymoglobulin arm will receive thymoglobulin 0.5 mg/kg on Days -2 and -1 prior to HPCT, and then a dose of 2.0 mg/kg on Day 0 (for a total dose o
Sponsors
McMaster University (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom of cGVHD at 12 months from transplantation defined as withdrawal of all systemic immunosuppressive agents without resumption up to 12 months after transplantation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to engraftment: complete blood count (CBC) measured daily until engraftment of platelets and neutrophils 2. Incidence of acute GVHD: participants will be assessed daily while in hospital and then according to local institutional practice until month 24 3. Incidence of cGVHD according to NIH Consensus criteria: measured at 100 days, 6 months, 12 months and 24 months using the "Chronic GVHD Assessment Form" 4. Incidence of cGVHD according to Sullivan Criteria: measured at day 100, months 6, 12 and 24 using the "Chronic GVHD Assessment Form" 5. Time to non-relapse mortality: time dependent variable 6. Time to all-cause mortality: time dependent variable 7. Time to relapse of leukaemia: measured according to local institutional practice at time there are signs/symptoms of relapse 8. Incidence of graft rejection or failure: CBC measured daily until engraftment of platelets and neutrophils 9. Incidence of serious infection: participants are assessed for signs of infection according to local institutional practice 10. Incidence of cytomegalovirus (CMV) activation: screening CMV is to occur according to local institutional practice 11. Quality of life: questionnaires collected at screening, 6, 12 and 24 months 12. Cost effectiveness: questionnaires collected at screening, 6, 12 and 24 months 13. Incidence of specific organ grades (National Institutes of Health [NIH]) of cGVHD: measured at 100 days, 6 months, 12 months and 24 months post-HPCT 14. Number of months on immunosuppression up to 12 months post-transplant: measured at 100 days, 6, 12 and 24 months post-transplant using the "Chronic GVHD Assessment Form" 15. Proportion of patients needing immunosuppression at 24 months: measured at 24 months post-HPCT using the "Chronic GVHD Assessment F | — |
Countries
Canada
Outcome results
None listed