Expired Study
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Buffalo, New York 14263


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00031980


Primary Contact:

Study Chair
Maria R. Baer, MD
University of Maryland Greenebaum Cancer Center


Backup Contact:

N/A


Location Contact:

Buffalo, New York 14263
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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