drugset / Trial / NCT01339988

Busulfan and Cyclophosphamide Instead of Total Boby Irradiation (TBI) and Cyclophosphamide for Hematological Malignancies Hematocrit (HCT)

NCT01339988

Phase 4 Unknown 10 enrolled Tel-Aviv Sourasky Medical Center
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

EvaluationDrugModalityDoseRoute
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