drugset / Trial / NCT04154735
Autologous Transplant Targeted Against Crohn's
NaSingle-groupOpen-labelTreatment
Summary
This study is a new Phase II trial to assess the toxicity and efficacy of autologous hematopoietic stem cell transplantation (HSCT) utilizing a new non-myeloablative conditioning regimen in patients with high-risk Crohn's disease (CD). The regimen will include low-dose immunosuppressive therapy and a targeted antibiotic for six to twelve months post-HSCT.
Timeline
- Start
- 2019-11
- Primary completion
- 2023-03
- Completion
- 2024-03
Outcome
Outcome not reported
Stopped: “Discontinued by Investigator”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alemtuzumab | Monoclonal antibody | — | — |
| Subject | Cyclophosphamide | Other / unclassified | — | — |
| Subject | Fludarabine | Small molecule | — | — |
| Subject | Rifaximin | Other / unclassified | — | — |
| Subject | Tacrolimus | Small molecule | — | — |
| Background | 2-MERCAPTOETHANESULFONIC ACID | Small molecule | — | — |
| Background | filgrastim | Protein / enzyme biologic | — | — |