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.
- 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.
- 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
- 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)
- 18 and over
- NCI CTC 0-3
- See Disease Characteristics
- Bilirubin no greater than 2 times upper limit of normal (ULN)
- Creatinine no greater than 2 times ULN
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT 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
- No prior cyclosporine therapy for this leukemia