Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2025-12-28 @ 1:15 PM
Study NCT ID:
NCT00081068
Status:
WITHDRAWN
Last Update Posted:
2013-01-08
First Post:
2004-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alemtuzumab in Treating Patients With Waldenstrom's Macroglobulinemia
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
Phase II Study of Campath-1H in Lymphoplasmacytic Lymphoma (Waldenstrom's 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WITHDRAWN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 Waldenstrom's macroglobulinemia.
PURPOSE: This phase II trial is studying how well alemtuzumab works in treating patients with Waldenstrom's macroglobulinemia.
Detailed Description:
OBJECTIVES:
* Determine the objective response in patients with Waldenstrom's 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 Waldenstrom's 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 ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| UCLA-0309058 | None | None | View |