At a glance
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A Prospective Study of Tocilizumab for the Prevention of Graft Failure and Graft-versus-Host Disease in Haplo-Cord Transplantation
In Brief
A Phase 2 clinical trial evaluating Tocilizumab, Fludarabine, and 3 other interventions for Hematologic Malignancy and Bone Marrow Transplant. Active but no longer recruiting, targeting 21 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate the safety of reducing and ultimately eliminating anti-thymocyte globulin (ATG) from the haplo-cord transplant conditioning regimen and replacing it with tocilizumab, an IL-6 receptor monoclonal antibody, to improve immune reconstitution and reduce relapse while preserving low rates of graft failure and graft versus host disease (GVHD).
Study Details
Timeline
Interventions
Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen
Fludarabine 30 mg/m2 intravenously administered on Day -7, Day -6, Day -5, Day -4, Day -3 of transplant conditioning regimen if under the age of 60. If over the age of 60, Fludarabine 30 mg/m2 intravenously administered on Day -5, Day -4 and Day -3 of transplant conditioning regimen.
Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen.
Anti-thymocyte globulin (ATG) 1.5 mg/kg
Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen