Title | Randomized phase III trial comparing early treatment with
fludarabine/cyclophosphamide + rituximab versus deferred
treatment in untreated Binet stage A patients with high risk of progression CLL 7 protocol of the GCLLSG and FCGCLL |
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Protocol IDs | EUDRACT-2005-003018-14) NCT00275054 |
Participating Countries | Germany, Austria, France |
Status | completed |
Contact | DCLLSG Office: Tel. +49 (0) 221-478-88220 |
Design | Prospective, european, multicentre, open-label, risk stratified, randomized phase III trial |
Primary Endpoint(s) | Event Free Survival (EFS) |
Secondary Endpoint(s) | For all patients: - Progression free survival (PFS) - Time to progression to Binet stages B and C - Time to treatment - Quality of life - Overall survival - Pharmacoeconomic analyses For patients included in the early treatment arm, the following criteria will be assessed: - Duration of response defined as the time elapsed between the first time a response is observed and re-treatment initiation - Adverse events related to treatment (treatment safety) |
Study Population | B-CLL, Binet-Stage A (as defined by NCI criteria), newly diagnosed (<1 year) No pretreatment Age ≥ 18 years |
Treatment | Cohort I Cycle 1: Rituximab i.v. (375 mg/m²/d, d1) Fludarabine i.v. (25 mg/m²/d, d2-4) Cyclophosphamide i.v. (250 mg/m²/d, d2-4) q28d Cycles 2 - 6: Rituximab i.v. (500 mg/m²/d, d1) Fludarabine i.v. (25 mg/m²/d, d2-4) Cyclophosphamide i.v. (250 mg/m²/d, d2-4) q28d |
Cohort II / Cohort III watch & wait |
|
Patients recruited | 825 patients (D, A and CH: 423 pts), thereof 75 treated high risk pts |
Time schedule | Recruitment period: 20 Oct. 2005 - 08 Jan. 2010 End of study: June 2015 Clinical Study Report / Publication: July 2016 End of archiving period: June 2025 |
Sponsor | German CLL Study Group (GCLLSG) |
Coordinating Investigator (D) | Prof. Dr. M. Hallek, Internal Medicine I, University Hospital of Cologne |
Coordinating Investigators (F) | Pr Vincent Lévy, Hôpital Saint Louis, Paris Pr Florence Cymbalista, Hôpital Avicenne, Bobigny |