drugset / Trial / NCT00697684
Reduced Intensity Conditioning With Clofarabine, Antithymocyte Globulin (ATG), Total Lymphoid Irradiation (TLI) Followed by Allogeneic Stem Cell Transplant
Phase 1
Completed
29 enrolled
Beth Israel Deaconess Medical Center
Genzyme, a Sanofi Company · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This study will examine the safety of clofarabine, TLI and ATG as a reduced conditioning regimen prior to allogeneic transplantation. The impact of the conditioning regimen on the presence of the circulating regulatory as compared to activated T cell populations will be assessed.The recovery of DC populations post-transplant will be examined, along with the effect of the regimen on disease free and overall survival.
Timeline
- Start
- 2008-06
- Primary completion
- 2020-12
- Completion
- 2023-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) | Protein / enzyme biologic | 1.5 mg/kg | — |
| Subject | Clofarabine | Other / unclassified | 20 mg/m2 | Intravenous |
| Subject | Clofarabine | Other / unclassified | 30 mg/m2 | Intravenous |
| Subject | Clofarabine | Other / unclassified | 40 mg/m2 | Intravenous |