Cyclosporine in Treating Patients With Low Blood Counts Caused By Hematologic Cancer

Study Overview
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Brief Summary
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RATIONALE: Cyclosporine may improve low blood counts caused by hematologic cancer. PURPOSE: Phase II trial to study the effectiveness of cyclosporine in treating patients who have low blood counts caused by hematologic cancer.

Detailed Description
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OBJECTIVES: Determine the frequency of cytopenic response in patients with T-cell large granular lymphocytic leukemia treated with cyclosporine. OUTLINE: This is a multicenter study. Patients receive oral cyclosporine every 12 hours. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 4 months for 1 year and then every 6 months for 9 years. PROJECTED ACCRUAL: A total of 9-30 patients will be accrued for this study within 3 years.

Official Title
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Phase II Study of Cyclosporine in T-Cell Large Granular Lymphocytic Leukemia

Conditions
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Anemia, Leukemia, Neutropenia, Thrombocytopenia

Intervention / Treatment
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* Drug: cyclosporine


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of T-cell large granular lymphocytic leukemia Increased numbers of large granular lymphocytes in peripheral blood smears CD3+CD8+CD57+ immunophenotype by flow cytometry AND CD3+CD57+ cell count at least 2,000/mm^3 OR CD3+CD57+ cell count at least 500/mm^3 with clonal T-cell receptor beta gene rearrangement Patients must have at least 1 of the following: Severe neutropenia (absolute neutrophil count (ANC) less than 500/mm^3) Neutropenia (ANC less than 1,000/mm^3) and recurrent infections Anemia (hemoglobin less than 9 g/dL) Thrombocytopenia (platelet count less than 50,000/mm^3) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: NCI CTC 0-3 Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) Renal: Creatinine no greater than 2 times ULN Other: Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Endocrine therapy: No concurrent hormonal therapy except steroids for adrenal failure or hormones for nondisease-related conditions (e.g., insulin for diabetes) No concurrent dexamethasone or other steroidal antiemetics Other: No prior cyclosporine therapy for this leukemia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cyclosporine<br>Patients receive oral cyclosporine every 12 hours. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 4 months for 1 year and then every 6 months for 9 years. | Drug: cyclosporine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of cytopemic response |  | Up to 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia, T-cell large granular lymphocyte leukemia, anemia, neutropenia, thrombocytopenia