Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00079755
Status:
COMPLETED
Last Update Posted:
2014-12-18
First Post:
2004-03-12
Brief Title:
Study of SGN-30 Antibody in Patients With Refractory or Recurrent Anaplastic Large Cell Lymphoma
Sponsor:
Seagen Inc
Organization:
Seagen Inc
Study Overview
Official Title:
A Phase II Multi-Dose Study of SGN-30 Anti-CD30 mAb in Patients With Refractory or Recurrent Hodgkins Disease or Anaplastic Large Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2014-12
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:
To investigate safety and antitumor activity of SGN-30 in patients with Hodgkins Disease and anaplastic large cell lymphoma ALCL
As of March 22 2005 interim analysis of the Hodgkins Disease HD arm has been completed per the statistical plan in the protocol SG030-0003 is now closed to further recruitment of HD patients
As of March 22 2005 interim analysis of the Hodgkins Disease HD arm has been completed per the statistical plan in the protocol SG030-0003 is now closed to further recruitment of HD patients
Detailed Description:
SGN-30 is the chimeric form of a novel murine monoclonal antibody mAb AC-10 that has specificity for CD30 The CD30 antigen has a very low expression on normal cells but is expressed on malignant cells in Hodgkins disease and anaplastic large cell lymphoma
This study is designed to define the toxicity profile and antitumor activity of SGN-30 in patients with refractory or recurrent Hodgkins disease and with refractory or recurrent anaplastic large cell lymphoma Patients will receive 6 weekly intravenous IV infusions of SGN-30 followed by a 4 week observation period
This study is designed to define the toxicity profile and antitumor activity of SGN-30 in patients with refractory or recurrent Hodgkins disease and with refractory or recurrent anaplastic large cell lymphoma Patients will receive 6 weekly intravenous IV infusions of SGN-30 followed by a 4 week observation period
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