LGL1 Trial

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
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