Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00081068
Status:
WITHDRAWN
Last Update Posted:
2013-01-08
First Post:
2004-04-07
Brief Title:
Alemtuzumab in Treating Patients With Waldenstroms Macroglobulinemia
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
Phase II Study of Campath-1H in Lymphoplasmacytic Lymphoma Waldenstroms Macroglobulinemia
Status:
WITHDRAWN
Status Verified Date:
2013-01
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:
RATIONALE Monoclonal antibodies such as alemtuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells
PURPOSE This phase II trial is studying how well alemtuzumab works in treating patients with Waldenstroms macroglobulinemia
PURPOSE This phase II trial is studying how well alemtuzumab works in treating patients with Waldenstroms macroglobulinemia
Detailed Description:
OBJECTIVES
Determine the objective response in patients with Waldenstroms macroglobulinemia treated with alemtuzumab
Determine the time to treatment failure in patients treated with this drug
Determine the toxicity of this drug in these patients
OUTLINE This is a multicenter study
Patients receive alemtuzumab IV over 2 hours on days 1 3 and 5 of weeks 1-6 course 1 in the absence of disease progression or unacceptable toxicity Patients with a complete response undergo observation Patients with stable disease or a minor or partial response receive an additional course of alemtuzumab administered as in course 1 on weeks 7-12
Patients are followed every 6 months for 2 years
PROJECTED ACCRUAL A total of 13-27 patients will be accrued for this study
Determine the objective response in patients with Waldenstroms macroglobulinemia treated with alemtuzumab
Determine the time to treatment failure in patients treated with this drug
Determine the toxicity of this drug in these patients
OUTLINE This is a multicenter study
Patients receive alemtuzumab IV over 2 hours on days 1 3 and 5 of weeks 1-6 course 1 in the absence of disease progression or unacceptable toxicity Patients with a complete response undergo observation Patients with stable disease or a minor or partial response receive an additional course of alemtuzumab administered as in course 1 on weeks 7-12
Patients are followed every 6 months for 2 years
PROJECTED ACCRUAL A total of 13-27 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UCLA-0309058 | None | None | None |