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| Title | First line therapy with methotrexate (MTX) and second line therapy with fludarabine of patients with T-cell large granular lymphocyte leukemia (T-LGL) |
|---|---|
| Protocol IDs | NCT00278265 (16 Jan 2006) |
| Status | prematurely terminated due to slow recruitment |
| Design | Prospective, open-label, multicentre, non-randomized phase II trial |
| Primary Endpoint(s) | Remission rates and duration of remission with parenteral MTX as first
line therapy in patients with T-LGL leukemia with need for treatment
because of anaemia or neutropenia, remission rate and duration of remission with fludarabine therapy in patients who failed to respond to MTX therapy |
| Secondary Endpoints | Incidence of side effects, rate of molecular remissions |
| Study Population | T-LGL leukemia with need for treatment No prior treatment with MTX or F Age ≥ 18 years |
| Treatment | First line Therapy : Methotrexate s.c. (10-20 mg/week)+ Folic Acid p.o. (5 mg/week) + Prednisone p.o. (1 mg/kg/d, d1-30; 40 mg/kg/d --> 5 mg/kg/d, d30-54) |
| Second line Therapy : Fludarabine i.v. (25 mg/m²/d, d1-3) q28d; 4 cycles |
|
| Patients recruited | 13 patients |
| Time schedule | study start: June 2005 recruitment period: 08.08.2005 - 27.05.2010 |
| Protocol Version | 15 Sept. 2004 Protocol |
| Sponsor | German CLL Study Group (GCLLSG) |
| Coordinating Investigator | Prof. Dr. Dr. Michael Kneba, Internal Medicine I, University Hospital of Cologne |
| Contact for public queries | German CLL Study Group (GCLLSG) |
| Contact for scientific queries | Prof. Dr. Clemens-Martin Wendtner, Internal Medicine I, University Hospital of Cologne Dr. Kirsten Fischer,GCLLSG |
| Documents (publicly available) |
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| Documents (password protected) |
Protocol, Registration Form, Ethic Approval, see Download Center |