drugset / Trial / NCT03842696
Vorinostat for Graft vs Host Disease Prevention in Children, Adolescents and Young Adults Undergoing Allogeneic Blood and Marrow Transplantation
Phase 1/2
Active not recruiting
43 enrolled
University of Michigan Rogel Cancer Center
National Center for Advancing Translational Sciences (NCATS) · collabNational Institutes of Health (NIH) · collab
NaSingle-groupOpen-labelPrevention
Summary
The purpose of this study is to determine the recommended phase 2 dose of the drug Vorinostat in children, adolescents and young adults following allogeneic blood or marrow transplant (BMT) and determine whether the addition of Vorinostat to the standard graft versus host disease (GVHD) prophylaxis will reduce the incidence of GVHD.
Timeline
- Start
- 2020-02-04
- Primary completion
- 2025-07-30
- Completion
- 2026-04-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vorinostat | Small molecule | 30 mg/m2 | — |
| Subject | Vorinostat | Small molecule | 45 mg/m2 | — |
| Subject | Vorinostat | Small molecule | 60 mg/m2 | — |
| Background | Cyclophosphamide | Other / unclassified | 50 mg/kg | — |
| Background | Cyclosporine | Peptide | — | Intravenous |
| Background | Methotrexate | Small molecule | 5 mg/m2 | Intravenous |
| Background | Mycophenolate Mofetil | Small molecule | 15 mg/kg | Intravenous |
| Background | Tacrolimus | Small molecule | — | Intravenous |