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Home > "S" Clinical Trials Conditions > Study of Autoimmune Lymphoproliferative Syndrome (ALPS)  Study of Autoimmune Lymphoproliferative Syndrome (ALPS)
Study of Autoimmune Lymphoproliferative Syndrome (ALPS)
For Condition: Autoimmune Disease,Lymphatic Disease,Lymphoproliferative Disorder,Canale-Smith Syndrome
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of the protocol is to allow for patients, and relatives of patients, who may have the newly described autoimmune lymphoproliferative syndrome, to be evaluated at the NIH Clinical Center. This evaluation will include blood and relevant tissue studies along with long-term clinical evaluations to define the biology, inheritance,clinical spectrum, and natural history of this syndrome. The aim of the research is to understand mechanisms involved in the development of expanded numbers of what is typically a rare population of immune cells (CD4-8-/TCRalpha/beta+ T cells, otherwise referred to as double negative T cells), and how these relate to the development of expanded numbers of immune cells and autoimmune (self against self) responses in patients with ALPS. Participants with ALPS will be invited to visit the NIH once a year or more frequently when clinically indicated for the next few years for clinicians and scientists to follow the course of their disease and to manage its complications. Knowledge gained from these studies provides important insights into the mechanisms of autoimmunity, the thymus gland, and the role that the immune system and genetics plays in ALPS. Autoimmune lymphoproliferative syndrome is a rare disease that affects both children and adults. Each of these three words helps describe the main features of this condition. The word autoimmune (self-immune) identifies ALPS as a disease of the immune system. The tools used to fight germs turn against our own cells and cause problems. The word lymphoproliferative describes the unusually large numbers of white blood cells (called lymphocytes (stored in the lymph nodes and spleens of people with ALPS. The word syndrome refers to the many common symptoms shared by ALPS patients. One of the causes of ALPS is defective apoptosis, or said another way, an individual has an abnormality in how well lymphocytes (immune cells) die when they are instructed to do so. It is normal for lymphocytes to disintegrate (e.g., die) when they have done their job. In people with ALPS and in some of their affected relatives, the genetic message for the cells to die is altered: the message is not received and the cells do not die when they should. As a result, people with ALPS develop an enlarged spleen, liver and lymph glands, along with a range of other problems involving white blood cell counts and overactive immune responses (autoimmune disease). Some patients have an increased risk of developing lymphatic cancers (lymphoma). Provided is a description of eligible study candidates: 1.) Any patient with ALPS, male or female and of any age. As a patient with ALPS, candidates must have: - a medical history of an enlarged spleen and/or enlarged lymph nodes over an extended period of time (past and/or current). - defective lymphocyte apoptosis, in vitro. - greater than or equal to 1 percent TCR alpha/beta+CD4-8- peripheral blood T cells. 2.) Relatives (any age) of patients and normal controls (18-65). 3.) Healthy normal volunteers will also be enrolled to provide data on normal cell behavior for comparison with patients. Additional information regarding ALPS and the research being conducted at the National Institutes of Health is available at the following World Wide Web (e.g., Internet) locations: http://www.niaid.nih.gov/publications/alps/ http://www.nhgri.nih.gov/DIR/GMBB/ALPS/.
Details: The purpose of the protocol is to allow for patients, and relatives of patients, who may have the newly described Autoimmune Lymphoproliferative Syndrome (ALPS) to be evaluated at the NIH Clinical Center. This evaluation will include blood and relevant tissue studies along with long-term clinical evaluation to define the biology, inheritance, clinical spectrum, and natural history of this syndrome. The aim of the research studies is to elucidate mechanisms underlying heightened polyclonal and autoimmune responses in these patients. Knowledge gained from these studies provides important insights into the mechanisms of autoimmunity, normal thymic and extra thymic T cell differentiation, TCR repertoire selection, and lymphomagenesis.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Study size: up to 300 patients Sex Distribution: Male and female Age range: All ages acceptable To be considered as having ALPS, patients must have greater than or equal to 1 percent TCR alpha/beta+ CD4-8- peripheral blood T cells, along with: A history of chronic splenomegaly and/or lymphadenopathy; Defective lymphocyte apoptosis, in vitro. Relatives (any age) of patients and normal controls (18-65) EXCLUSION CRITERIA: HIV infection in any potential subject, and recognized or suspected immunologic disorders or complicating medical or psychiatric conditions in potential unrelated controls.
Total Enrollment: 800
Location and Contact Information:
National Institute of Allergy and Infectious Diseases (NIAID) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 930063; 93-I-0063
Study Start Date: December 18, 1992
Record last reviewed: December 23, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001350
Other Canale-Smith Syndrome Studies:
1. Study of Autoimmune Lymphoproliferative Syndrome (ALPS)
2. Pyrimethamine to Treat Autoimmune Lymphoproliferative Syndrome
3. A Study of Isoprinosine in Patients with Lymph Node Disease
4. The Safety and Effectiveness of Isoprinosine in Patients with Weakened Immune Systems and Lymph Node Disease
5. A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Immunodepressed Patients With Uncomplicated Generalized Lymphadenopathy
Related Studies:
Other Canale-Smith Syndrome Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Study of Autoimmune Lymphoproliferative Syndrome (ALPS)
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