Anemia, Leukemia, Neutropenia, Thrombocytopenia
Conditions
Keywords
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
Brief 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.
Detailed 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.
Interventions
DRUGcyclosporine
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of cytopemic response | Up to 10 years |
Countries
United States
Outcome results
None listed