2006‐0767.

Trial name or title	Alemtuzumab + rituximab consolidation in CLL (NCT00771602)
Methods	Consolidation therapy for patients with CLL with evidence of residual disease following prior chemo(immuno)therapy. Randomisation: Three arms: rituximab versus alemtuzumab versus alemtuzumab + rituximab
Participants	Inclusion Criteria Patients with CLL, CLL/PLL, or SLL who have achieved an NCI‐WG nodular partial (nPR) or CR with documentation of residual disease by MRD flow cytometry following chemotherapy or chemo‐immunotherapy. Age >/=18 years. ECOG performance status </=2; serum creatinine </= 2 mg/dL; serum total bilirubin </= 2 mg/dL; serum AST or ALT < 4 x ULN.
Interventions	Rituximab Rituximab 375 mg/m2 by standard IV infusion on days 1, 8, 15, and 22 of weeks 1 to 4. Alemtuzumab Alemtuzumab 30 mg SC during week 1 Rituximab plus alemtuzumab Rituximab 375 mg/m2 by standard IV infusion on days 1, 8, 15, and 22 of weeks 1 to 4. Alemtuzumab 30 mg SC during week 1
Outcomes	Primary outcome Number of patients with molecular remissions at 52 weeks MRD Secondary outcomes PFS 52 week toxicity rate
Starting date	August 2008
Contact information	The University of Texas M.D. Anderson Cancer Center (Stefan Faderl M.D./ Associate Professor )
Notes	Sponsor: Genzyme Estimated enrolment: 100 Estimated primary completion date: December 2010 (Final data collection date for primary outcome measure) Study status according to ClinicalTrials.gov: This study is terminated ‐ 1 patient enrolled