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

Sponsored by Alliance for Clinical Trials in Oncology

About this trial

Last updated 9 years ago

Study ID

CALGB-10003

Status

Completed

Type

Interventional

Phase

Phase 2

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 20 years ago

What is this trial about?

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.

What are the Participation Requirements?

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

Locations

Location

Status