drugset / Trial / NCT00586547
Evaluating the Use of RFT5-dgA to Deplete Alloreactive Cells Prior to Haploidentical Stem Cell Transplantation
Phase 1
Completed
11 enrolled
Baylor College of Medicine
University of Texas, Southwestern Medical Center at Dallas · collab
NaSingle-groupOpen-labelTreatment
Summary
This study is designed to determine the number of donor lymphocytes that can be given to recipients of haploidentical stem cell transplants after depletion of recipient-reactive T lymphocytes by ex-vivo treatment with a fixed dose of RFT5-dgA immunotoxin, and will result in a rate of Grade III/IV GVHD of \< / = 25%, to analyze immune reconstitution in these patients, and to measure their overall and disease free survival, at 100 days and at 1 year.
Timeline
- Start
- 2000-07
- Primary completion
- 2008-09
- Completion
- 2008-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | T-Cell Infusion | Cell therapy | 1000 cells/kg | Other |
| Subject | T-Cell Infusion | Cell therapy | 10000 cells/kg | Other |
| Subject | T-Cell Infusion | Cell therapy | 100000 cells/kg | Other |
| Subject | T-Cell Infusion | Cell therapy | 1e+06 cells/kg | Other |
| Subject | T-Cell Infusion | Cell therapy | 5e+06 cells/kg | Other |