drugset / Trial / NCT01047072
Low-Dose Conditioning Followed by Donor Stem Cell Transplant in Treating Patients With Severe Systemic Sclerosis
Phase 2
Withdrawn
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
National Cancer Institute (NCI) · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of the study is to see how well reduced intensity conditioning followed by a stem cell transplant from a donor (allogeneic) works in treating patients with severe systemic sclerosis. In an allogeneic stem cell transplant procedure, stem cells are taken from a healthy donor and transplanted into the patient. Stem cells can be donated by a family member or an unrelated donor who is a complete tissue type match.
Timeline
- Start
- —
- Primary completion
- 2017-09
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cyclophosphamide | Other / unclassified | — | Oral |
| Subject | Mycophenolate Mofetil | Small molecule | — | Oral |
| Comparator | Rituximab | Monoclonal antibody | — | Intravenous |
| Background | Fludarabine | Small molecule | — | Intravenous |
| Background | Tacrolimus | Small molecule | — | Oral |