drugset / Trial / NCT04395222
Tocilizumab for the Prevention of Graft Failure and GVHD in Haplo-Cord Transplantation
Non-randomizedSequentialOpen-labelTreatment
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).
Timeline
- Start
- 2020-10-07
- Primary completion
- 2022-09-28
- Completion
- 2027-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Thymoglobulin | Protein / enzyme biologic | 1.5 mg/kg | — |
| Subject | Tocilizumab | Monoclonal antibody | 8 mg/kg | Intravenous |
| Background | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |
| Background | Melphalan | Small molecule | 140 mg/m2 | Intravenous |