Gribben 2005.

Methods	Randomisation To arms: up to 6 cycles fludarabine plus alemtuzumab (Flu‐Cam) versus up to 6 cycles fludarabine plus rituximab (Flu‐R) Recruitment period Not stated Median follow‐up time Not stated
Participants	Eligibility criteria Relapsed B‐cell CLL patients after failure to first‐line treatment Patients recruited (N = 12) Flu‐Cam (N = 4): (withdraws or exclusions not stated) Flu‐R (N = 8): (withdraws or exclusions not stated) Mean age 67 years, no data for each arm Gender 7 male, 5 female no data for each arm Stage of disease (Rai stage group) Stage I‐II: Flu‐Cam: 2 patients (50.0%); Flu‐R: 1 patient (12.5%) Stage III‐IV: Flu‐Cam: 2 patients (50.0%); Flu‐R: 7 patients (87.5%) Country Not stated
Interventions	Patients were assessed monthly for response while on therapy, and interim restaging occurred at cycle 4. Those who achieved a CR received no further therapy, whereas those who achieved a PR or SD received 2 additional cycles. Flu‐Cam Patients received fludarabine 25 mg/m2 IV and alemtuzumab 30 mg subcutaneus, on days 1 to 5 of each cycle. Flu‐R Patients received fludarabine 25 mg/m2  IV on days 1 to 5, and  rituximab  375 mg/m2 IV on days 1 and 4 of the first cycle, In the subsequent cycles they received additional rituximab  375 mg/m2 IV on day 1.
Outcomes	Outcomes Reported CRR ORR Adverse events Number of patients discontinuing the study because of drug‐related adverse events Not evaluated or reported OS PFS Time to next treatment TRM MRD
Notes	No conflict of interest statement in the abstract.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "patients were randomized to" Comment: The authors did not describe the method used to generate the allocation sequence.
Allocation concealment (selection bias)	Unclear risk	No information provided.
Blinding (performance bias and detection bias) overall survival	Unclear risk	Comment: The study did not report this outcome.
Blinding (performance bias and detection bias) All other outcomes	Unclear risk	Comment: Patient and physician unblinded. No information about blinding of outcome assessor provided.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	The information about completeness of outcome data is insufficient to permit judgement.
Selective reporting (reporting bias)	High risk	Preplanned outcomes (ClinicalTrials.gov: NCT00086775) in the abstract‐publications reported for all pre‐defined outcomes except: 1‐year survival Time to progression Duration of response Adverse events Molecular response rate Lymphocyte and lymphocyte subset recovery (CD3, CD3/CD4, CD3/CD8, CD20) Time to complete response
Other bias	Unclear risk	In this phase II trial 12 patients only were randomised, without providing a rationale for the uneven distribution (4 patients alemtuzumab arm versus 8 patients in the rituximab arm). Comment: The review authors have no further information on the uneven distribution to permit judgement.

CLL: Chronic lymphocytic leukaemia; CMV: cytomegalovirus; CNS: central nervous system; CR: complete response; CRR: complete response rate; HIV: human immunodeficiency virus; IV: intravenous; MRD: minimal residual disease; ORR: overall response rate; OS: overall survival; PCR: polymerase chain reaction; PFS: progression‐free survival; PO: orally; PR: partial response; TRM: treatment‐related mortality; WHO: World Health Organization.