A Phase 2 interventional study of MTX followed by fludarabine in T-Cell Large Granular Lymphocytic Leukemia, sponsored by German CLL Study Group. Terminated at 7 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-03.
Sponsored by German CLL Study Group · Phase 2, Interventional, and Treatment
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.
OBJECTIVES:
Primary
Secondary
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.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 12 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →German CLL Study Group is the lead sponsor of 36 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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
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
Also known as: methotrexate, fludarabine phosphate
Response rate
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
Time frame: 12 months after inclusion in the study
Duration of remission
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
Time frame: up to 24 months after inclusion in the study
Molecular remission rate
Time frame: 2 months after the last dose of study medication
Adverse events rate and severity
Adverse events were reported according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC version 2.0)
Time frame: up to 28 days after the last dose of study medication
Plan to share: No
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This study is terminated, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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German CLL Study Group