Trial Information

First Line Therapy With Methotrexate (MTX) and Second Line Therapy With Fludarabine of Patients With T-Cell Large Granular Lymphocyte Leukemia (T-LGL)

OBJECTIVES:

Primary

- Determine remission rates and duration of remission in patients with T-cell large
granular lymphocytic (T-LGL) leukemia needing intervention because of anemia or
neutropenia and are treated with parenteral methotrexate (MTX) as first-line therapy

- Determine remission rate and duration of remission in patients who fail to respond to
MTX therapy and are subsequently treated with fludarabine as second-line therapy.

Secondary

- Determine the side effects of these drugs in these patients.

- Determine the rate of molecular remissions in patients treated with these drugs.

OUTLINE: This is a nonrandomized, open-label, multicenter study.

Patients receive methotrexate subcutaneously once weekly in the absence of disease
progression or unacceptable toxicity. Patients not achieving a response to methotrexate
receive fludarabine IV on days 1-3. Treatment with fludarabine repeats every 28 days for 4
courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.