A Single-arm Phase II Study of Alemtuzumab in Combination With High-dose Methylprednisolone in CLL Patients With p53 Deletion

Summary

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.

Timeline

Start

—

Primary completion

—

Completion

—

Drugs

Indications