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Tocilizumab for the Prevention of Graft Failure and GVHD in Haplo-Cord Transplantation
Sponsor: Weill Medical College of Cornell University
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).
Official title: A Prospective Study of Tocilizumab for the Prevention of Graft Failure and Graft-versus-Host Disease in Haplo-Cord Transplantation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
21
Start Date
2020-10-07
Completion Date
2027-06
Last Updated
2026-01-06
Healthy Volunteers
No
Interventions
Tocilizumab
Tocilizumab 8 mg/kg intravenously administered as a single dose on Day -1 of transplant conditioning regimen
Fludarabine
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
Melphalan 140 mg/m2 intravenously administered on Day -2 of transplant conditioning regimen.
Anti-thymocyte globulin (rabbit)
Anti-thymocyte globulin (ATG) 1.5 mg/kg
Total Body Irradiation
Total Body Irradiation (TBI) 2 Gray, administered on Day -4 and Day -3 of transplant conditioning regimen
Locations (1)
Weill Cornell Medical College
New York, New York, United States