drugset / Trial / NCT01339988
Busulfan and Cyclophosphamide Instead of Total Boby Irradiation (TBI) and Cyclophosphamide for Hematological Malignancies Hematocrit (HCT)
NaSingle-groupOpen-labelTreatment
Summary
Long-term follow-up studies have demonstrated significant late toxicities of total body irradiation (TBI), which are most marked in children radiated at a young age. Growth failure, decline in cognitive function, and endocrine abnormalities have all been described. Good outcomes can be achieved with alkylating agents only as a preparative regimen. This plan will use a combination of busulfan and cyclophosphamide (Bu/Cy) with or without antithymocyte globulin (ATG) to reduce the late toxicities of therapy that includes TBI.
Timeline
- Start
- 2011-06
- Primary completion
- 2014-06
- Completion
- 2019-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Busulfan | Small molecule | 0.8 mg/kg | Intravenous |
| Subject | Busulfan | Small molecule | 1 mg/kg | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 50 mg/kg | Intravenous |