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


Phase 2
18 Years
N/A
Not Enrolling
Both
Anemia, Leukemia, Neutropenia, Thrombocytopenia

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Trial Information

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


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.

Inclusion 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

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

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Supportive Care

Outcome Measure:

Frequency of cytopemic response

Safety Issue:

No

Principal Investigator

Maria R. Baer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Maryland Greenebaum Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000069246

NCT ID:

NCT00031980

Start Date:

March 2002

Completion Date:

Related Keywords:

  • Anemia
  • Leukemia
  • Neutropenia
  • Thrombocytopenia
  • stage I chronic lymphocytic leukemia
  • stage II chronic lymphocytic leukemia
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • T-cell large granular lymphocyte leukemia
  • anemia
  • neutropenia
  • thrombocytopenia
  • Anemia
  • Leukemia
  • Leukemia, Lymphoid
  • Neutropenia
  • Thrombocytopenia
  • Leukemia, Large Granular Lymphocytic

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263