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

Publication date: Available online 17 January 2020Source: The Lancet HaematologyAuthor(s): Irwin Walker, Tony Panzarella, Stephen Couban, Felix Couture, Gerald Devins, Mohamed Elemary, Geneviève Gallagher, Holly Kerr, John Kuruvilla, Stephanie J Lee, John Moore, Thomas Nevill, Gizelle Popradi, Jean Roy, Kirk R Schultz, David Szwajcer, Cynthia Toze, Ronan Foley, Cell Therapy Transplant CanadaSummaryBackgroundPrevious trials testing prevention strategies for chronic graft versus host disease (GVHD) have measured its cumulative incidence. In this trial of anti-thymocyte globulin, we measured treatment-independence at a long-term timepoint as the primary endpoint.MethodsThis was a randomised, open-label, multicentre, phase 3 trial done at ten centres in Canada and one in Australia. Eligible patients had a haematological malignancy (leukaemia, myelodysplastic syndrome, or lymphoma), were between 16 and 70 years of age, eligible for transplantation with a Karnofsky score of at least 60, and received an unrelated donor (fully matched or one-locus mismatched at HLA-A, HLA-B, HLA-C, or DRB1 loci) graft following myeloablative or non-myeloablative–reduced intensity conditioning. Patients were randomly assigned to receive anti-thymocyte globulin 4·5 mg/kg plus standard GVHD prophylaxis (cyclosporine or tacrolimus plus methotrexate or mycophenolate) or standard GVHD prophylaxis alone. The primary endpoint, freedom from immunosuppressive therapy without resumption at 12 months, was pr...
Source: The Lancet Haematology - Category: Hematology Source Type: research