Effect of Cyclosporine Therapy on Gene Expression in Patients With Large Granular Lymphocyte Leukemia
Large Granular Lymphocytic Leukemia, LGL Leukemia
About this trial
This is an interventional treatment trial for Large Granular Lymphocytic Leukemia focused on measuring Large Granular Lymphocyte (LGL), LGL, Leukemia, Cyclosporine, Microarray, Gene Expression, Cyclosporin, Large Granular Lymphocyte Leukemia, LGL Leukemia
Eligibility Criteria
INCLUSION CRITERIA: All patients must have a histologic or cytologic diagnosis of T-cell LGL leukemia as determined by the Laboratory of Pathology or Hematology at the Clinical Center, National Institutes of Health All patients must have hemocytopenias such as granulocyte count less than 1,200/ul, platelet count less than 100,000/ul or hemoglobin less than 10 g/dl, or require hematopoietic support (transfusion or colony stimulating factors) to maintain counts at these or higher levels. Patients must have measurable or evaluable disease Patients must have a creatinine of less than 2.0 mg/dl. Omission of cytotoxic chemotherapy for 3 weeks prior to entry into the trial is required. However, patients receiving stable corticosteroids will be eligible. Age greater than 18 years Karnofsky performance greater than 70% Patients must have a life expectancy of greater than 3 months. Patients must be able to understand and sign an Informed Consent form. All female patients must use adequate contraception during participation in this trial and for three months after completing therapy. EXCLUSION CRITERIA: Patients with uncontrolled hypertension Pregnant and nursing patients are not eligible for the study as CSA crosses the placenta. Based on clinical use, premature births and low birth weight were consistently observed. Breast-feeding is contraindicated because CSA enters the blood milk and may possibly be administered to the child. Underlying immunodeficiency state including human immunodeficiency virus (HIV) seropositivity. Positive for antibodies to hepatitis C or positive for hepatitis B surface antigen, Patients with serious intercurrent illnesses, concurrent hepatic, renal, cardiac, neurologic, pulmonary, infectious or metabolic disease of such severity that it would preclude the patients' ability to tolerate cyclosporine. Patients who received cyclosporine for LGL leukemia previously and failed to respond.
Sites / Locations
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Arms of the Study
Arm 1
Experimental
LGL Patients administered cyclosporine
Large Granular Lymphocyte Leukemia (LGL) is a low grade non-Hodgkins lymphoma characterized by tissue invasion of the marrow, spleen, and liver. Cyclosporine 5-10 mg/kg/day was administered as an oral preparation given every 12 hours. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml.