2006‐0767

Trial name or title	Alemtuzumab and rituximab for consolidation in CLL (NCT00771602)
Methods	Consolidation therapy for patients with CLL with evidence of residual disease following prior chemo(immuno)therapy Randomisation: 3 arms: rituximab versus alemtuzumab versus alemtuzumab plus rituximab
Participants	Inclusion criteria: patients with CLL, CLL/PLL, or SLL who have achieved an NCI‐WG nPR or CR with documentation of residual disease by MRD flow cytometry following chemotherapy or chemoimmunotherapy patients with CLL, CLL/PLL or SLL who have achieved an NCI‐WG PR following prior chemotherapy or chemoimmunotherapy age ≥ 18 years ECOG performance status ≤ 2 without previous treatment with alemtuzumab plus rituximab in combination
Interventions	Arm 1: 375 mg/m2 IV rituximab alone Arm 2: 30 mg SC alemtuzumab alone Arm 3: 375 mg/m2 IV rituximab plus 30 mg SC alemtuzumab
Outcomes	Outcomes and time points from the registered protocol of the study that are considered in the review: will report: PFS CRR ORR AEs will not report: OS time to next treatment TRM MRD number of patients discontinuing the study because of drug‐related AEs
Starting date	August 2008
Contact information	Stefan Faderl, M.D. at The University of Texas M.D. Anderson Cancer Center
Notes	Estimated enrolment: 100 Estimated primary completion date: December 2010 Study status according to ClinicalTrials.gov: this study is terminated ‐ 1 patient enrolled