Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00292760
Status:
COMPLETED
Last Update Posted:
2009-12-16
First Post:
2006-02-15
Brief Title:
A Single-arm Phase II Study of Alemtuzumab in Combination With High-dose Methylprednisolone in CLL Patients With p53 Deletion
Sponsor:
Royal Marsden NHS Foundation Trust
Organization:
Royal Marsden NHS Foundation Trust
Study Overview
Official Title:
A Single-arm Phase II Study of Alemtuzumab in Combination With High-dose Methylprednisolone in CLL Patients With p53 Deletion
Status:
COMPLETED
Status Verified Date:
2009-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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-prednisoneAlentuzumab 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 toleratedThereafter 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 10gm2 starting on Day 1 and repeating the cycle every 28 days
Treatment will be given for 16 weeks ie 4 cycles of methylprednisolone Treatment will be discontinued if there is no response after 8 weeks or if toxicity becomes unacceptable
The trial consists of giving continuous alemtuzumab and cyclical high-dose methyl-prednisoneAlentuzumab 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 toleratedThereafter 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 10gm2 starting on Day 1 and repeating the cycle every 28 days
Treatment will be given for 16 weeks ie 4 cycles of methylprednisolone Treatment will be discontinued if there is no response after 8 weeks or if toxicity becomes unacceptable
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UKCLL 06 CAM-PRED | None | None | None |