Methotrexate Followed by Fludarabine in Patients With T-Cell Large Granular Lymphocytic Leukemia
- Conditions
- T-Cell Large Granular Lymphocytic Leukemia
- Interventions
- Registration Number
- NCT00278265
- Lead Sponsor
- German CLL Study Group
- Brief 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 12
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MTX followed by fludarabine MTX followed by fludarabine MTX is given with a dose of 10-20mg weekly Fludarabine is dosed with 25mg/m2 day 1-3 of 28 days, up to 4 cycles
- Primary Outcome Measures
Name Time Method Response rate 12 months after inclusion in the study he remission status was assessed according to the guidelines of the National Cancer Institute Sponsored Working Group (NCI-WG) \[20 Cheson BD, Bennett JM, Grever M, et al. National Cancer Institute-sponsored Working Group guidelines for chronic lymphocytic leukemia: revised guidelines for diagnosis and treatment. Blood 1996; 87: 4990-4997.\]. Restaging after the end of treatment included evaluation of the peripheral blood and physical examination; use of imaging techniques (ultrasound and conventional radiography or computertomography) and evaluation of the bone marrow were mandatory to assign a complete remission
- Secondary Outcome Measures
Name Time Method Molecular remission rate 2 months after the last dose of study medication Duration of remission up to 24 months after inclusion in the study he remission status was assessed according to the guidelines of the National Cancer Institute Sponsored Working Group (NCI-WG) \[20 Cheson BD, Bennett JM, Grever M, et al. National Cancer Institute-sponsored Working Group guidelines for chronic lymphocytic leukemia: revised guidelines for diagnosis and treatment. Blood 1996; 87: 4990-4997.\]. Restaging after the end of treatment included evaluation of the peripheral blood and physical examination; use of imaging techniques (ultrasound and conventional radiography or computertomography) and evaluation of the bone marrow were mandatory to assign a complete remission
Adverse events rate and severity up to 28 days after the last dose of study medication Adverse events were reported according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC version 2.0)
Trial Locations
- Locations (7)
Praxis fuer Haematologie und Interne Onkologie
🇩🇪Norderstedt, Germany
St. Marien - Krankenhaus Siegen GMBH
🇩🇪Siegen, Germany
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
🇩🇪Ulm, Germany
Robert Roessle Comprehensive Cancer Center - Charite Campus Buch
🇩🇪Berlin, Germany
University Hospital Schleswig-Holstein - Kiel Campus
🇩🇪Kiel, Germany
I. Frauenklinik und Hebammenschule der Ludwig-Maximillians Universitaet Muenchen
🇩🇪Munich, Germany
Klinikum Schwaebisch Gmuend Stauferklinik
🇩🇪Mutlangen, Germany