Status:
TERMINATED
Effect of Cyclosporine Therapy on Gene Expression in Patients With Large Granular Lymphocyte Leukemia
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Large Granular Lymphocytic Leukemia
LGL Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ce...
Detailed Description
Background: * LGL leukemia is a low grade non-Hodgkins Lymphoma characterized by tissue invasion of the marrow, spleen and liver * Recurrent infections due to chronic neutropenia and transfusion-depe...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00363779
Start Date
June 1 2006
End Date
November 1 2010
Last Update
July 21 2015
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892