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Treatment of T-Large Granular Lymphocyte (T-LGL) Lymphoproliferative Disorders With Cyclosporine

Phase 1
Not Enrolling
Anemia, Leukemia, T-Cell, Lymphocytosis, Neutropenia, Thrombocytopenia

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Trial Information

Treatment of T-Large Granular Lymphocyte (T-LGL) Lymphoproliferative Disorders With Cyclosporine

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 characteristic surface markers corresponding to activated cytotoxic (CD3+, CD8+)
lymphocytes. They are often associated with quite severe neutropenia, anemia, and
thrombocytopenia which may be life-threatening. There is some evidence that the abnormal
cytotoxic lymphocyte population may cause the cytopenias by suppressing hematopoiesis,
although the mechanism is unclear. Case reports suggest that immunosuppressive therapy
directed toward T cells may reverse the cytopenia. This pilot study involving up to 25
patients evaluates the clinical response to cyclosporine, an immunosuppressive drug, and
seeks to elucidate the mechanism underlying the cytopenia.

Inclusion 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

Mothers must not be breast feeding.

Patients must be able to give informed consent.

Patients must not be HIV positive.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Primary Purpose: Treatment


United States: Federal Government

Study ID:




Start Date:

September 1996

Completion Date:

September 2000

Related Keywords:

  • Anemia
  • Leukemia, T-Cell
  • Lymphocytosis
  • Neutropenia
  • Thrombocytopenia
  • Anemia
  • Chronic T Cell Lymphocytosis with Neutropenia
  • Immunosuppression
  • Neutropenia
  • T-LGL Leukemia
  • Anemia
  • Leukemia
  • Leukemia, T-Cell
  • Lymphocytosis
  • Lymphoproliferative Disorders
  • Neutropenia
  • Thrombocytopenia



National Heart, Lung and Blood Institute (NHLBI) Bethesda, Maryland  20892