NCT00292760|CompletedPhase 2
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Sponsor study identifier
Secondary identifiers
interventional
N/A
0 countries
N/A
Study Start
Not reported
Date not reportedPrimary Completion
Not reported
Date not reportedStudy Completion
Not reported
Date not reportedThis is a phase II open label study for patients with p53-deleted CLL who require treatment. Both untreated and previously treated patients are eligible for study entry. The trial consists of giving continuous alemtuzumab and cyclical high-dose methyl-prednisone.Alentuzumab is given intravenously during the first 4 weeks of treatment to ensure that adequate serum levels are achieved quickly. The drug will be administered daily during the first week, commencing at a dose of 3mg, and increasing to 10mg and then up to the target dose of 30mg as tolerated.Thereafter alemtuzumab will be given at a dose 30mg thrice weekly. From week 5, alemtuzumab will be given at the same dose but by the subcutaneous route of administration. Methlyprednisolone will be given for 5 consecutive days at a daily dose of 1.0g/m2, starting on Day 1 and repeating the cycle every 28 days. Treatment will be given for 16 weeks (i.e 4 cycles of methylprednisolone). Treatment will be discontinued if there is no response after 8 weeks, or if toxicity becomes unacceptable.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 15, 2006
Actual (reported)February 16, 2006
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Andrew Pettitt
Royal Liverpool University Hospital
First Submitted
February 15, 2006
First Posted
February 16, 2006
Last Updated
December 16, 2009
Record last verified: 2009-12
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Source: ClinicalTrials.gov.
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Source retrieved:
Phase II Clinical Trial of Alemtuzumab to Treat B-cell Chronic Lymphocytic Leukemia
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