Rituximab (Rituxan) for the Prevention of EBV-LPD Epstein Barr Virus (EBV) Lymphoproliferative Disorder Post T Cell Depleted Unrelated and HLA Mis-Matched Related HSCT
The purpose of this study is to determine if we can prevent Epstein Barr Virus lymphomas by the monthly administration of an (antibody) protein against B lymphocytes called Rituximab. Although this medicine has been approved by the Food and Drug Administration to treat patients with other types of lymphomas, and has been used to treat a small number of patients with EBV lymphomas and other types of B-cell leukemias, it has not been approved to try and prevent EBV-lymphomas. Use of Rituximab to try to prevent EBV-lymphomas is therefore experimental.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Trial of Rituximab (Rituxan) for the Prevention of EBV-LPD Post T Cell Depleted Unrelated and HLA Mis-Matched Related HSCT|
- To determine the safety of Rituximab prophylaxis in patients following TCD unrelated or HLAmismatched related HSCT. [ Time Frame: conclusion of study ] [ Designated as safety issue: Yes ]
- To examine B cell reconstitution in patients receiving Rituximab prophylaxis following TCD unrelated and TCD HLA-mismatched related HCT. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
- To determine the incidence of acute and chronic graft versus host disease in recipients of a TCD unrelated or HLA-mis-matched HCT who receive Rituximab. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
|Study Start Date:||March 2008|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Patients (n=25) following a T cell depleted HLA-mis-matched related or unrelated hematopoietic stem cell transplant (HSCT) will be treated with monthly Rituximab.
Patients following a T cell depleted HLA-mis-matched related or unrelated hematopoietic stem cell transplant (HSCT) will be treated with monthly Rituximab 375 mg/m2 starting approximately 1 month post transplant (no later than day 45), and continuing monthly until the CD4 cell count is > 200 cells/ul or a maximum of 6 doses have been given.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00648037
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Trudy Small, MD||Memorial Sloan Kettering Cancer Center|