drugset / Trial / NCT00720629
Visilizumab for the Prevention of Graft-versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation
Phase 2
Terminated
8 enrolled
H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI) · collabNational Institutes of Health (NIH) · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
The purpose of this study was to test whether a new drug named visilizumab would decrease the severity of graft-versus-host disease in patients treated with a mismatched donor. Investigators planned to use visilizumab in combination with tacrolimus and methotrexate as the "study treatment".
Timeline
- Start
- 2007-12
- Primary completion
- 2013-12
- Completion
- 2013-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Visilizumab | Monoclonal antibody | 3 mg/m2 | Intravenous |
| Comparator | ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) | Protein / enzyme biologic | 3.25 mg/kg | Intravenous |
| Comparator | Methotrexate | Small molecule | 10 mg/m2 | Intravenous |
| Comparator | Tacrolimus | Small molecule | 0.02 mg/kg | Oral |
| Comparator | Tacrolimus | Small molecule | 0.03 mg/kg | Oral |