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
NCT00648037 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26
Last updated 2016-02-01
Summary
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.
Conditions
- Hodgkin's Disease
- Leukemia
- Myelodysplastic Syndrome
- Non-Hodgkin's Lymphoma
Interventions
- DRUG
-
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.
Sponsors & Collaborators
-
Memorial Sloan Kettering Cancer Center
lead OTHER
Principal Investigators
-
Trudy Small, MD · Memorial Sloan Kettering Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-03-31
- Primary Completion
- 2008-12-31
- Completion
- 2008-12-31
Countries
- United States
Study Locations
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