Protocol Number: 06-I-0005

Title:

Evaluation of Risk Factors for Development of Epstein-Barr Virus Lymphoproliferative Disease

Number:

06-I-0005

Summary:

This study will examine how the immune system responds to infection with the Epstein-Barr virus (EBV), a virus that infects white blood cells called B lymphocytes, and at factors that might correlate with EBV lymphoproliferative disease (LPD), which results in a marked increase in lymphocytes. In addition to infecting B lymphocytes in the blood, EBV is also shed from epithelial cells that line the throat. This study also will determine whether EBV persists in these epithelial cells by examining blood and throat washings of people taking rituximab, a drug that kills and eliminates nearly all B lymphocytes in the blood.

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.

Sponsoring Institute:

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

Patients about to undergo, or have recently undergone, an organ or stem cell transplant: Patients must be at least 5 years old, be willing to have blood samples and throat washings stored for future research, and be able to sign the consent form and willing to comply with study procedures.

Patients who have a recent diagnosis of EBV LPD or EBV-related disease: Patients must be at least 5 years old, be willing to have blood samples and throat washings stored for future research, and be able to sign the consent form and willing to comply with study procedures.

Patients about to receive, or receiving, rituximab (anti-CD20 antibody): Patients must be at least 5 years old, be willing to have blood samples and throat washings stored for future research, and be able to sign the consent form and willing to comply with study procedures.

Patients about to receive, or receiving, cytotoxic chemotherapy without rituximab: Patients must be at least 5 years old, be willing to have blood samples and throat washings stored for future research, and be able to sign the consent form and willing to comply with study procedures.

Patients with a recent diagnosis of acute IM: Patients must be at least 18 years old, be willing to have blood samples stored for future research, and be able to sign the consent form and willing to comply with study procedures.

EXCLUSION CRITERIA:

Blood will not be drawn if it is not felt to be safe for the patient in the opinion of principal or associate investigator.

Throat washings will not be obtained if the patient has painful oral lesions.

Special Instructions:

Currently Not Provided

Keywords:

Lymphoma

Herpesvirus

Transplant

Rituximab

Infectious Mononucleosis

Recruitment Keyword(s):

Epstein-Barr Virus

EBV

Epstein-Barr Virus Lymphoproliferative

Disease

Condition(s):

Epstein-Barr Virus Infections

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Institute of Allergy and Infectious Diseases

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Cohen JI. Epstein-Barr virus infection. N Engl J Med. 2000 Aug 17;343(7):481-92. Review. No abstract available.

Haque T, Crawford DH. PCR amplification is more sensitive than tissue culture methods for Epstein-Barr virus detection in clinical material. J Gen Virol. 1997 Dec;78 ( Pt 12):3357-60.

Cohen JI. Epstein-Barr virus lymphoproliferative disease associated with acquired immunodeficiency. Medicine (Baltimore). 1991 Mar;70(2):137-60. Review.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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