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Investigator(s):
John E. Janik, M.D. Principal Investigator Phone: 301-402-2913 janikj@mail.nih.gov
Referral Contact(s):
Suzanne Fioravanti, R.N., B.S.N., O.C.N. Research Nurse Phone: 301-594-6544 Fax: 301-402-1001 fioravas@mail.nih.gov	Guinevere Chun, R.N., B.S.N., O.C.N. Research Nurse Phone: 301-451-7868 Fax: 301-402-1001 gchun@mail.nih.gov

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Primary Eligibility:

• Histologic or cytologic diagnosis of T-cell LGL leukemia
• Measurable or evaluable disease
• 18 years of age and over
• Hemocytopenias such as granulocyte count < 1,200/ul, platelet count < 100,000/ul or hemoglobin < 10 g/dl, or require hematopoietic support (transfusion or colony stimulating factors) to maintain counts at these or higher levels
• Creatinine < 2.0 mg/dl
• Karnofsky performance > 70%
• Life expectancy > 3 months
• No uncontrolled hypertension
• No immunodeficiency; no HIV; no Hepatitis C; no Hepatitis B
• No serious intercurrent illnesses; no concurrent hepatic, renal, cardiac, neurologic, pulmonary, infectious or metabolic disease
• No other condition that would preclude study participation
• Patients who received cyclosporine for LGL leukemia previously and failed to respond will be excluded from study participation

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Treatment Plan:

• Patients receive cyclosporine at a dose of 5-10mg/kg/day in divided doses, with doses adjusted to maintain a therapeutic serum level between 200-400ng/ml; therapeutic levels will be maintained for 3 months
• Tumor response will be evaluated after 3 months’ therapy, the dose of CsA may then be tapered to that required to sustain a response or discontinued if no evidence of response, or after relapse
• Blood sampling or lymphapheresis for collection of circulating malignant cells will be performed at a number of different time points
• Gene expression profiling will be carried out on Affymetrix microarrays to compare pretreatment and post-treatment samples

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 6/18/08
Updated: 12/11/06