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Treatment of T-Large Granular Lymphocyte (T-LGL) Lymphoproliferative Disorders with Cyclosporine Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Treatment of T-Large Granular Lymphocyte (T-LGL) Lymphoproliferative Disorders with Cyclosporine conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Treatment of T-Large Granular Lymphocyte (T-LGL) Lymphoproliferative Disorders with Cyclosporine Clinical research trials and Treatment of T-Large Granular Lymphocyte (T-LGL) Lymphoproliferative Disorders with Cyclosporine health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Treatment of T-Large Granular Lymphocyte (T-LGL) Lymphoproliferative Disorders with Cyclosporine. Treatment of T-Large Granular Lymphocyte (T-LGL) Lymphoproliferative Disorders with Cyclosporine Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Treatment of T-Large Granular Lymphocyte (T-LGL) Lymphoproliferative Disorders with Cyclosporine clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Treatment of T-Large Granular Lymphocyte (T-LGL) Lymphoproliferative Disorders with Cyclosporine condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > Treatment of T-Large Granular Lymphocyte (T-LGL) Lymphoproliferative Disorders with Cyclosporine  Treatment of T-Large Granular Lymphocyte (T-LGL) Lymphoproliferative Disorders with Cyclosporine
Treatment of T-Large Granular Lymphocyte (T-LGL) Lymphoproliferative Disorders with Cyclosporine
For Condition: Anemia,Leukemia, T-Cell,Lymphocytosis,Neutropenia,Thrombocytopenia
Status: Completed
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: T Cell Large Granular Lymphocyte (T-LGL) Lymphoproliferative Disorders are a heterogeneous group of uncommon diseases which may involve a polyclonal or a monoclonal T cell population, which bear characteristic surface markers corresponding to activated cytotoxic (CD3+, CD8+) lymphocytes. They are often associated with quite severe neutropenia, anemia, and thrombocytopenia which may be life-threatening. There is some evidence that the abnormal cytotoxic lymphocyte population may cause the cytopenias by suppressing hematopoiesis, although the mechanism is unclear. Case reports suggest that immunosuppressive therapy directed toward T cells may reverse the cytopenia. This pilot study involving up to 25 patients evaluates the clinical response to cyclosporine, an immunosuppressive drug, and seeks to elucidate the mechanism underlying the cytopenia.
Details: T Cell Large Granular Lymphocyte (T-LGL) Lymphoproliferative Disorders are a heterogeneous group of uncommon diseases which may involve a polyclonal or a monoclonal T cell population, which bear characteristic surface markers corresponding to activated cytotoxic (CD3+, CD8+) lymphocytes. They are often associated with quite severe neutropenia, anemia, and thrombocytopenia which may be life-threatening. There is some evidence that the abnormal cytotoxic lymphocyte population may cause the cytopenias by suppressing hematopoiesis, although the mechanism is unclear. Case reports suggest that immunosuppressive therapy directed toward T cells may reverse the cytopenia. This pilot study involving up to 25 patients evaluates the clinical response to cyclosporine, an immunosuppressive drug, and seeks to elucidate the mechanism underlying the cytopenia.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Patients must be greater than or equal to 18 years of age. Peripheral blood absolute LGL count of greater than or equal to 300/ul (performed on a manual differential), with LGL cells having the characteristic appearance of large lymphocytes with abundant pale blue cytoplasm, with or without a perinuclear clear zone, with varying degrees of azurophilic granules. Immunophenotypic studies of peripheral blood showing an increased population of T-LGL (Staining for: CD3, CD8, and either CD16 or CD57+/- CD56). Severe neutropenia (less than or equal to 500 neutrophils/uL of peripheral blood), or severe thrombocytopenia (less than or equal to 20,000 platelets/uL, or moderate thrombocytopenia (less than or equal to 50,000 platelets/uL with active bleeding , or anemia (hemoglobin less than or equal to 9 gm/dL), or red blood cell transfusion requirement of greater than or equal to 2 units/month for two months prior to initiation of CsA treatment. Patients must not have had previous treatment with CsA or FK506. Patients must not have a reactive LGL lymphocytosis to a viral infection. Patients must not have a ECOG performance status of greater than 3. Patients must not be currently pregnant, or unwilling to take oral contraceptives unless postmenopausal. Mothers must not be breast feeding. Patients must be able to give informed consent. Patients must not be HIV positive.
Total Enrollment: 25
Location and Contact Information:
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 960142; 96-H-0142
Study Start Date: September 25, 1996
Record last reviewed: October 2, 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001533
Other Neutropenia Studies:
1. Treatment of T-Large Granular Lymphocyte (T-LGL) Lymphoproliferative Disorders with Cyclosporine
2. Treatment of Tac-Expressing Cutaneous T-Cell Lymphoma (CTCL) and Adult T-Cell Leukemia (ATL) with Yttrium-90 Radiolabeled Anti-Tac
Related Studies:
Other Neutropenia Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Treatment of T-Large Granular Lymphocyte (T-LGL) Lymphoproliferative Disorders with Cyclosporine
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