Ignite Creation Date:
2024-05-06 @ 12:50 AM
Last Modification Date:
2024-10-26 @ 10:55 AM
Study NCT ID:
NCT01671813
Status:
WITHDRAWN
Last Update Posted:
2013-07-25
First Post:
2012-08-21
Brief Title:
Brentuximab Vedotin in CD30 Positive Epstein Barr Virus EBV Positive DLBCL of Elderly
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Pilot Study of Brentuximab Vedotin in CD30 Positive EBV Positive Diffuse Large B-Cell Lymphomas of the Elderly
Status:
WITHDRAWN
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated by pharmaceutical sponsor - no accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main purpose of this study is to test if brentuximab vedotin has an effect on cancer in patients with a certain type of large B-Cell Lymphoma The side effects unwanted effects of SGN-35 in patients with this certain type of large B-Cell Lymphoma will also be studied It is not known if brentuximab vedotin is better or worse than other treatment that might be given
Detailed Description:
Brentuximab vedotin is a type of drug called an antibody drug conjugate ADC ADCs usually have 2 parts a part that targets cancer cells the antibody and a cell killing part the chemotherapy Antibodies are proteins that are part of the immune system They can stick to and attack specific targets on cells The antibody part of brentuximab vedotin sticks to a target called CD30 CD30 is an important molecule on some cancer cells including non-Hodgkin lymphoma and some normal cells of the immune system The cell killing part of brentuximab vedotin is a chemotherapy called monomethyl auristatin E MMAE After the brentuximab vedotin attaches to the CD30 part of the cell the MMAE enters the cell and kills it
More than 350 people with cancer have already been given brentuximab vedotin in research studies These research studies were done to test the safety of different doses of brentuximab vedotin and to find out if brentuximab vedotin is active against cancer
More than 350 people with cancer have already been given brentuximab vedotin in research studies These research studies were done to test the safety of different doses of brentuximab vedotin and to find out if brentuximab vedotin is active against cancer
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 |
|---|---|---|---|
| SGN 35-IST-006 | OTHER | Seattle Genetics Inc | None |