This is a phase II, prospective, multicenter, open-label study to evaluate the efficacy and safety of Alemtuzumab in patients with relapse and refractory B-cell chronic lymphocytic leukemia.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Escalation Phase: Initial Doses of Alemtuzumab 3mg/day by intravenous(IV) infusion until tolerated, then Alemtuzumab 10mg/day IV infusion until tolerated, then Alemtuzumab 30mg IV infusion until tolerated. Escalation to 30mg/day should be accomplished in 3\~7 days. Stable dose Phase: Once 30mg/day infusion of Alemtuzumab was tolerated, then continue 3 times per week. The total duration of Alemtuzumab therapy including escalation and stable dose phase is 12 weeks. More than 30mg daily or 90mg weekly dose is prohibited \--------------------------------------------------------------------------------
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
Objective Response Rate(ORR)
Objective Response Rate was defined as the proportion of patients who have CR, PR during the study as evaluated according to National Comprehensive Cancer Network(NCCN) guideline 2010 response criteria. Response categories include Complete Response(CR) and Partial Response(PR). ORR=CR+PR
Time frame: up to 1 year
Progression-Free Survival
Progression-Free Survival was defined as the time from randomization to disease progression (PD) or death due to any cause, whichever comes first.
Time frame: up to 1 year
Disease Control Rate(DCR)
Patients were evaluated according to National Comprehensive Cancer Network(NCCN) guideline 2010 response criteria. The best response observed during the study is summarized. Response categories include Complete Response(CR), Partial Response(PR) and Stable Disease(SD). DCR=CR+PR+SD
Time frame: up to 1 year
Duration of Response(DOR)
Duration of response was analyzed for patients who achieved a complete release(CR) or partial release(PR) and was defined as the time from the first date of documented response to the date of disease progression or death due to any cause.
Time frame: up to 1 year
Overall Survival
Overall Survival was defined as the duration from randomization to death due to any cause.
Time frame: up to 1 year
Summary of patients with Adverse Events(AEs)
Analysis of patients with adverse experiences according to CTCAE Version 4.
Time frame: up to 1 year
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