Chronic Lymphocytic Leukaemia Clinical Trial
Official title:
A Single-arm Phase II Study of Alemtuzumab in Combination With High-dose Methylprednisolone in CLL Patients With p53 Deletion
This 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.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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