Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow recruitment
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| T-Cell Large Granular Lymphocytic Leukemia | T-Cell Large Granular Lymphocyte Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MTX followed by fludarabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MTX followed by fludarabine
- description
- 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
- interventionNames
- Drug: MTX followed by fludarabine
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- 12 months after inclusion in the study
- description
- 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 outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Confirmed diagnosis of T-cell large granular lymphocytic (T-LGL) leukemia * Must have concurrent anemia or neutropenia PATIENT CHARACTERISTICS: * Life expectancy ≥ 2 years * Not pregnant * Fertile patients must use effective contraception * No other malignancy * No active infection PRIOR CONCURRENT THERAPY: * No prior immunosuppressive treatment * No previous treatment with methotrexate or fludarabine
References
Publications (0)
Data not yet available