Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Supportive care	Completed	18 and over	NCI	CALGB-10003 NCT00031980

Objectives

1. Determine the frequency of cytopenic response in patients with T-cell large granular lymphocytic leukemia treated with cyclosporine.

Entry 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/mm³

    OR

  • CD3+CD57+ cell count at least 500/mm³ 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/mm³)
  • Neutropenia (ANC less than 1,000/mm³⁾ and recurrent infections
  • Anemia (hemoglobin less than 9 g/dL)
  • Thrombocytopenia (platelet count less than 50,000/mm³)

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• No concurrent chemotherapy

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

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• No prior cyclosporine therapy for this leukemia

Patient Characteristics:

Age:

• 18 and over

Performance status:

• NCI CTC 0-3

Life expectancy:

• Not specified

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

Expected Enrollment

A total of 9-30 patients will be accrued for this study within 3 years.

Outcomes

Frequency of cytopemic response

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.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Maria Baer, MD, Protocol chair		Ph: 410-328-8708; 800-888-8823

Registry Information
Official Title		Phase II Study of Cyclosporine in T-Cell Large Granular Lymphocytic Leukemia
Trial Start Date		2002-03-15
Trial Completion Date		2005-05-23
Registered in ClinicalTrials.gov		NCT00031980
Date Submitted to PDQ		2002-01-24
Information Last Verified		2008-05-09
NCI Grant/Contract Number		CA31946

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