Expired Study
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New York, New York 10065


Purpose:

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.


Criteria:

Inclusion Criteria: - Patient must be a recipient of aT cell depleted unrelated or HLA mis-matched related HSCT for the treatment of a malignancy or immunodeficiency disease. - Patients must have an ANC > or = to 1500 cells/ul on the day of first treatment. - Patients with acute or chronic leukemia, or MDS prior to transplant must be in remission defined as <5% blasts in the bone marrow. - Patient with must be in remission. - Patient must be Hepatitis B surface antigen negative pre transplant. - Patients must have adequate cardiac function defined as a left ventricular ejection fraction at rest of >50% documented pre-transplant. - Patient may be of either gender and of any ethnic background. - Patient may be of any age. There is no upper age restriction. - Patients or their guardians must be able to understand the nature and risk of the proposed study and be able to sign consent. Exclusion Criteria: - Karnofsky score <70% - Female patients who are pregnant or lactating. - Evidence of EBV-LPD or circulating EBV copy number >1000. - Active uncontrolled bacterial or fungal infection. - Prior history of Hepatitis B infection or Hepatitis B surface antigen positivity pre transplant. - HIV-1,2 sero-positive patients. - Patients or guardians not signing informed consent. - Patients with prior allergic reaction to Rituximab or other murine monoclonal antibody. - Patients taking other investigational agents under another protocol unless discussed and approved in advance by Genentech and the IDEC Therapeutic Director.


NCT ID:

NCT00648037


Primary Contact:

Principal Investigator
Trudy Small, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10065
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 16, 2018

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