Protocol Number: 06-I-0005
The following may be eligible for this study: 1) People who have recently undergone or are about to undergo organ or stem cell transplants, or who are known to be at very high risk for EVB LPD; 2) people who have recently been diagnosed with EBV LPD; and 3) people who are receiving or are about to receive treatment with rituximab. All participants must be at least 5 years old. Participants undergo the following tests and procedures: -Adults (18 years of age or older) about to receive a transplant: Blood is drawn before the transplant, then every 2 weeks for 3 months, then once a month for the first year and then every 3 months the second year. -Children about to receive a transplant: Blood is drawn before the transplant, then every 2 weeks for 3 months, then once a month for up to 2 years. -Adults diagnosed with EBV LPD: Blood is drawn every week for 8 weeks, then once a month for the first year and then once every 3 months the second year. -Children diagnosed with EBV LPD: Blood is drawn every week for 8 weeks, then once a month for up to 2 years. -Adults and children taking rituximab: Blood is drawn before rituximab therapy starts, then once every 3 weeks during therapy and for up to 4 months after therapy is stopped. Patients also gargle with salt water up to four times before rituximab therapy starts, up to four times during therapy and for up to 4 months after therapy is stopped. Patients with EBV LPD may undergo other testing, such as computed tomography (CT), magnetic resonance imaging (MRI) or positron emission tomography (PET) scans and a tissue biopsy if it is felt to be helpful in evaluating the disease. Adult patients with EBV may also be asked to undergo leukapheresis (a procedure for collecting large numbers of white blood cells) up to two times during the study. In a process similar to donating a unit of whole blood, the patient lies on a recliner while blood is withdrawn through a needle placed in an arm vein. The blood flows into a cell separator machine, which spins the blood to separate the blood cells. The white cells are collected in a plastic bag inside the machine, and the red cells and plasma are returned to the patient through a second needle in the other arm. A blood thinner is given through one of the needles to prevent the blood from clotting while it is in the machine. The procedure may last from 1-3 hours, depending on how many cells are collected.
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National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 01/30/2009
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