drugset / Trial / NCT03434730

Tocilizumab for the Prevention of Graft Versus Host Disease After Cord Blood Transplantation

NCT03434730

Phase 2 Completed 46 enrolled Memorial Sloan Kettering Cancer Center
NaSingle-groupOpen-labelTreatment

Summary

The aim of the research in this study is to make participants' transplant safer by reducing the risk of developing GVHD and GVHD-related complications by giving participants a dose of the drug tocilizumab in addition to the standard approach for GVHD prevention. Tocilizumab reduces the risk of inflammation by blocking the effect of Interleukin-6, a protein that exists in high levels in the blood when there is inflammation. Participants who receive stem cell transplants have high levels of this protein in their blood early after transplant. Therefore, the goal of this study is to reduce the risk of inflammation after transplant with the addition of Tocilizumab. This could decrease the risk of developing GVHD and GVHD-associated complications.

Timeline

Start
2018-02-07
Primary completion
2025-04-18
Completion
2025-04-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Tocilizumab Monoclonal antibody
Background Cyclosporine Peptide
Background Mycophenolate Mofetil Small molecule 1000 mg
Background filgrastim Protein / enzyme biologic 300 ug Subcutaneous
Background filgrastim Protein / enzyme biologic 480 ug Subcutaneous