ECOG‐E1908

Trial name or title	Rituximab and alemtuzumab in treating older patients with progressive CLL (NCT01013961)
Methods	Phase II comparing standard and low‐dose rituximab for initial treatment of progressive CLL in older patients using alemtuzumab and rituximab Randomisation: 2 arms: alemtuzumab plus standard rituximab versus alemtuzumab plus low‐dose rituximab
Participants	Inclusion criteria: diagnosis of CLL has progressive, symptomatic CLL no massive splenomegaly > 6 cm below left costal margin, at rest, on clinical examination no lymphadenopathy > 5 cm in any diameter ECOG performance status 0 to 3 no prior treatment for CLL
Interventions	1. Arm I: course 1: alemtuzumab SC and standard‐dose rituximab IV on days 8, 15, 22 and 29; courses 2 and 3: alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26 and standard‐dose rituximab IV on days 3, 10, 17 and 24 2. Arm II: course 1: alemtuzumab as in arm 1 and also low‐dose rituximab IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29 and 31 courses 2 and 3: alemtuzumab as in arm I and low‐dose rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26
Outcomes	Outcomes and time points from the registered protocol of the study that are considered in the review: will report: CRR ORR MRD AEs will not report: OS PFS TRM time to next treatment number of patients discontinuing the study because of drug‐related AEs
Starting date	October 2010
Contact information	Clive S. Zent, MD Mayo Clinic
Notes	Estimated enrolment: 90 Estimated primary completion date: February 2012 Study status according to ClinicalTrials.gov: this study is currently recruiting participants