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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001533
First Posted: December 10, 2002
Last Update Posted: January 23, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institutes of Health Clinical Center (CC)
  Purpose
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.

Condition Intervention Phase
Anemia Leukemia, T-Cell Lymphocytosis Neutropenia Thrombocytopenia Drug: cyclosporine Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Treatment of T-Large Granular Lymphocyte (T-LGL) Lymphoproliferative Disorders With Cyclosporine

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 25
Study Start Date: September 1996
Estimated Study Completion Date: September 2000
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 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001533


Locations
United States, Maryland
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001533     History of Changes
Other Study ID Numbers: 960142
96-H-0142
First Submitted: November 3, 1999
First Posted: December 10, 2002
Last Update Posted: January 23, 2007
Last Verified: October 1999

Keywords provided by National Institutes of Health Clinical Center (CC):
Anemia
Chronic T Cell Lymphocytosis with Neutropenia
Immunosuppression
Neutropenia
T-LGL Leukemia

Additional relevant MeSH terms:
Thrombocytopenia
Neutropenia
Lymphoproliferative Disorders
Lymphocytosis
Leukemia, T-Cell
Blood Platelet Disorders
Hematologic Diseases
Agranulocytosis
Leukopenia
Leukocyte Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukocytosis
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Cyclosporins
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors