NCT00278265

Methotrexate Followed by Fludarabine in Patients With T-Cell Large Granular Lymphocytic Leukemia

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: German CLL Study Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as methotrexate and fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well methotrexate works as first-line therapy and fludarabine works as second-line therapy in treating patients with T-cell large granular lymphocytic leukemia.

Detailed description

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.

Conditions

• T-Cell Large Granular Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	MTX followed by fludarabine	MTX should be administered with 10-20mg weekly, calculated according to the body weight. Fludarabine should be administered with 25mg/m2 on day 1-3 of 28 days, up to 4 cycles

Timeline

• Start date: 2005-06-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2006-01-18
• Last updated: 2016-10-03

Locations

7 sites across 1 country: Germany