A Single-arm Phase II Study of Alemtuzumab in Combination With High-dose Methylprednisolone in CLL Patients With p53 Deletion
|ClinicalTrials.gov Identifier: NCT00292760|
Recruitment Status : Completed
First Posted : February 16, 2006
Last Update Posted : December 16, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukaemia||Drug: Alemtuzumab Drug: Methyprednisolone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single-arm Phase II Study of Alemtuzumab in Combination With High-dose Methylprednisolone in CLL Patients With p53 Deletion|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00292760
|Principal Investigator:||Andrew Pettitt||Royal Liverpool University Hospital|