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



Status:Completed
Conditions:Blood Cancer, Anemia, Hematology, Hematology, Hematology, Leukemia
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:March 2002
End Date:May 2005

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

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.

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.

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
We found this trial at
1
site
666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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