Chronic Lymphocytic Leukemia Clinical Trial
Cyclosporine in Treating Patients With Low Blood Counts Caused By Hematologic Cancer
Summary
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.
Full Description
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.
Eligibility Criteria
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
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There is 1 Location for this study
Buffalo New York, 14263, United States
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