Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00057967
Status:
COMPLETED
Last Update Posted:
2019-02-06
First Post:
2003-04-07
Brief Title:
Alemtuzumab in Treating Patients With Relapsed or Refractory Advanced Mycosis Fungoides or Sézary Syndrome
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Phase II Trial Of Campath-1H In Patients With RelapsedRefractory Advanced Mycosis Fungoides or Sezary Syndrome
Status:
COMPLETED
Status Verified Date:
2019-01
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 relapsed or refractory advanced mycosis fungoides or Sézary syndrome
PURPOSE This phase II trial is studying how well alemtuzumab works in treating patients with relapsed or refractory advanced mycosis fungoides or Sézary syndrome
Detailed Description:
OBJECTIVES
Determine the response rate of patients with relapsed or recurrent advanced mycosis fungoides or Sézary syndrome treated with alemtuzumab
Determine the toxicity of this drug in these patients
OUTLINE Patients receive alemtuzumab IV over 2 hours three times per week Treatment continues for up to 12 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 12-37 patients will be accrued for this study within 2 years
Determine the response rate of patients with relapsed or recurrent advanced mycosis fungoides or Sézary syndrome treated with alemtuzumab
Determine the toxicity of this drug in these patients
OUTLINE Patients receive alemtuzumab IV over 2 hours three times per week Treatment continues for up to 12 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 12-37 patients will be accrued for this study within 2 years
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 |
|---|---|---|---|
| NU 99H8 | OTHER | None | None |
| STU00012258 | OTHER | Northwestern University IRB | None |