Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00051701
Status:
TERMINATED
Last Update Posted:
2015-03-05
First Post:
2003-01-15
Brief Title:
Phase III Study of CAMPATH in Patients With Relapsing or Refractory Non-Hodgkins Lymphoma
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
Phase III Study of CAMPATH in Patients With Relapsing or Refractory Non-Hodgkins Lymphoma
Status:
TERMINATED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the optimal dose of Campath for patients with relapsing or refractory failed standard therapy non-Hodgkins lymphoma The study will also evaluate the safety of the drug and whether it is effective in treating these patients
Detailed Description:
This study is being conducted in 2 parts with the primary objective of part 1 being to determine the maximum tolerated dose MTD of CAMPATH alemtuzumab MABCAMPATH CAMPATH administered intravenously IV once a week as treatment for relapsing or refractory non-Hodgkins lymphoma NHL The primary objective of part 2 is to determine the overall response rate complete response CRunconfirmed plus partial response of weekly IV CAMPATH in the treatment of relapsing or refractory NHL This is a Phase III study open-label multicenter study to evaluate the efficacy and safety of weekly IV CAMPATH as therapy for patients with relapsing or refractory non-Hodgkins lymphoma
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 |
|---|---|---|---|
| BLA 99-0786 | None | None | None |