GCLLSG‐CLL7

Trial name or title	Rituximab, fludarabine, and cyclophosphamide or observation alone in treating patients with stage 0, I, or II CLL (NCT00275054)
Methods	Randomised Phase III trial comparing early treatment with FluC‐R versus deferred treatment in untreated Binet stage a patients with CLL and high risk of progression Randomisation: 2 arms: FluC‐R versus deferred treatment ('watch and wait')
Participants	Inclusion criteria: established diagnosis of B‐CLL, first diagnosis within 12 months before inclusion in study, previously untreated disease Binet stage A disease (Rai stage 0, I or II) life expectancy > 6 months ECOG performance status 0 to 2 all parameters for risk stratification (lymphocyte doubling time, cytogenetics, unmutated IgVH, and serum thymidine kinase level > 10 U/L) present no prior chemotherapy, radiotherapy or antibody treatment
Interventions	Arm 1: patients receive rituximab IV on day 1, fludarabine IV on days 1‐3, and cyclophosphamide IV on days 1‐3. Treatment repeats every 28 days for up to 6 courses Arm 2: patients undergo observation only until disease progression
Outcomes	Outcomes and time points from the registered protocol of the study that are considered in the review: will report: OS PFS time to next treatment CRR OR MRD AEs will not report: TRM number of patients discontinuing the study because of drug‐related AEs
Starting date	October 2005
Contact information	Michael Hallek, MD Medizinische Universitaetsklinik I at the University of Cologne
Notes	Estimated enrolment: 600 Estimated primary completion date: not reported Study status according to ClinicalTrials.gov: this study is currently recruiting participants