DCLLSG

CLL7 Trial

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
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