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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Treatment Plan for Hematologic Malignancies Using Intravenous Busulfan and Cyclophosphamide Instead of Total Boby Irradiation (TBI) and Cyclophosphamide to Examine Results, Success and Side Effects of

Brief 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.

Detailed Summary:
Sponsor: Tel-Aviv Sourasky Medical Center

Current Primary Outcome: Overall survival [ Time Frame: Five years ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Disease free survival [ Time Frame: Five years ]

Original Secondary Outcome: Same as current

Information By: Tel-Aviv Sourasky Medical Center

Dates:
Date Received: April 20, 2011
Date Started: June 2011
Date Completion: June 2019
Last Updated: April 20, 2011
Last Verified: April 2011