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.

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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.

View Eligibility Criteria

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

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 2

Estimated Enrollment:

30

Study ID:

NCT00031980

Recruitment Status:

Completed

Sponsor:

Alliance for Clinical Trials in Oncology

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There is 1 Location for this study

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Roswell Park Cancer Institute
Buffalo New York, 14263, United States

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 2

Estimated Enrollment:

30

Study ID:

NCT00031980

Recruitment Status:

Completed

Sponsor:


Alliance for Clinical Trials in Oncology

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