Methotrexate as First-Line Therapy and Fludarabine as Second-Line Therapy in Treating Patients With T-Cell Large Granular Lymphocytic Leukemia
Recruitment status was Recruiting
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.
Drug: fludarabine phosphate
|Study Design:||Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||First Line Therapy With Methotrexate (MTX) and Second Line Therapy With Fludarabine of Patients With T-Cell Large Granular Lymphocyte Leukemia (T-LGL)|
- Response rate at 1 year [ Designated as safety issue: No ]
- Duration of remission [ Designated as safety issue: No ]
- Molecular remission rate [ Designated as safety issue: No ]
- Adverse events rate and severity [ Designated as safety issue: Yes ]
|Study Start Date:||June 2005|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00278265
|Robert Roessle Comprehensive Cancer Center - Charite Campus Buch||Recruiting|
|Berlin, Germany, D-13125|
|Contact: Contact Person 49-30-9417-1243 firstname.lastname@example.org|
|University Hospital Schleswig-Holstein - Kiel Campus||Recruiting|
|Kiel, Germany, D-24105|
|Contact: Contact Person 49-431-1697-5231 email@example.com|
|I. Frauenklinik und Hebammenschule der Ludwig-Maximillians Universitaet Muenchen||Recruiting|
|Munich, Germany, D-80337|
|Contact: Contact Person 49-89-7095-4230 firstname.lastname@example.org|
|Klinikum Schwaebisch Gmuend Stauferklinik||Recruiting|
|Mutlangen, Germany, D-73557|
|Contact: Contact Person 49-717-1701-1302 email@example.com|
|Praxis fuer Haematologie und Interne Onkologie||Recruiting|
|Norderstedt, Germany, 22844|
|Contact: Contact Person 49-40-526-5060 firstname.lastname@example.org|
|St. Marien - Krankenhaus Siegen GMBH||Recruiting|
|Siegen, Germany, D-57072|
|Contact: Contact Person 49-271-231-1310 email@example.com|
|Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm||Recruiting|
|Ulm, Germany, D-89081|
|Contact: Contact Person 49-731-5004-5548 firstname.lastname@example.org|
|Study Chair:||Michael Kneba||University of Schleswig-Holstein|