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

Alliance for Clinical Trials in Oncology

Status and phase: Completed; Phase 2

Conditions: Anemia; Thrombocytopenia; Neutropenia; Leukemia

Treatments: Drug: cyclosporine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00031980

CDR0000069246 (Registry Identifier)

CALGB-10003

Details and patient eligibility

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.

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

cyclosporine

Experimental group

Description:

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.

Treatment:

Drug: cyclosporine