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LGL Leukemia clinical trials

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NCT ID: NCT00363779 Terminated - LGL Leukemia Clinical Trials

Effect of Cyclosporine Therapy on Gene Expression in Patients With Large Granular Lymphocyte Leukemia

Start date: June 2006
Phase: Phase 2
Study type: Interventional

Background: - Large granular lymphocyte (LGL) leukemia is a low-grade non-Hodgkin's lymphoma. - LGL is associated with low numbers of white blood cells (leading to recurring infections), red blood cells (causing anemia) and platelets (causing abnormal bleeding). - Cyclosporine (CSA) is an immunosuppressive drug that improves low blood cell counts in about 50 percent of patients with LGL leukemia. Objectives: - To identify what factors determine why cyclosporine works in some patients and not in others. - To identify what causes low blood counts in LGL leukemia. Eligibility: Patients 18 years of age and older with LGL leukemia. Design: - Patients have a medical history, physical examination blood tests, bone marrow biopsy and x-ray studies, including chest x-rays and computed tomography (CT) scans of the chest, abdomen and pelvis. Patients with an easily accessible enlarged lymph node have a node biopsy (removal of a small piece of tissue for microscopic examination). - Patients take cyclosporine twice a day by mouth. Blood samples are taken at least weekly to adjust the cyclosporine dosing to maintain therapeutic serum levels. - Patients undergo apheresis (collection of white blood cells) at a number of different time points in the study (maximum 6 times) to look at the differences in the leukemia cells before and during treatment with cyclosporine. For apheresis, blood is withdrawn through a needle in an arm vein and directed through a catheter (plastic tube) into a machine that separates it into its components. The white cells are extracted and the rest of the blood is returned through the same needle or through a second needle in the other arm.