Status:
COMPLETED
Treatment of T-Large Granular Lymphocyte (T-LGL) Lymphoproliferative Disorders With Cyclosporine
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Anemia
Leukemia, T-Cell
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
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 chara...
Detailed Description
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 chara...
Eligibility 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.
Key Trial Info
Start Date :
September 1 1996
Trial Type :
INTERVENTIONAL
End Date :
September 1 2000
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00001533
Start Date
September 1 1996
End Date
September 1 2000
Last Update
July 17 2006
Active Locations (1)
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1
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, Maryland, United States, 20892