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
|ClinicalTrials.gov Identifier: NCT00648037|
Recruitment Status : Completed
First Posted : April 1, 2008
Results First Posted : February 1, 2016
Last Update Posted : February 1, 2016
|Condition or disease||Intervention/treatment|
|Hodgkin's Disease Leukemia Myelodysplastic Syndrome Non-Hodgkin's Lymphoma||Drug: Rituximab|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Trial of Rituximab (Rituxan) for the Prevention of EBV-LPD Post T Cell Depleted Unrelated and HLA Mis-matched Related HSCT|
|Study Start Date :||March 2008|
|Primary Completion Date :||December 2008|
|Study Completion Date :||December 2008|
Patients following a T cell depleted HLA-mis-matched related or unrelated hematopoietic stem cell transplant (HSCT) will be treated with monthly Rituximab.
Rituximab 375 mg/m^2 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.
- Safety of Rituximab Prophylaxis [ Time Frame: 3 months post transplant ]The following stopping rules will be employed to determine that the risks of graft failure, severe GvHD, treatment-related mortality, infection, and EBV-LPD in study patients are not increased over expected. In addition, patients will be removed from study if they develop irreversible non-hematologic Grade III toxicity or any Grade IV toxicity felt to be related or possibly related to study drug.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|