Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00184002
Status:
COMPLETED
Last Update Posted:
2017-08-10
First Post:
2005-09-12
Brief Title:
Doxorubicin Doxil Combined With Rituxan Cyclophosphamide Vincristine and Prednisone in Newly Diagnosed Aggressive Non-Hodgkins Lymphomas
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
A Phase II Study Of Pegylated Liposomal Doxorubicin Doxil In Combination With Rituxan Cyclophosphamide Vincristine and Prednisone DR-COP In Newly Diagnosed Aggressive Non-Hodgkins Lymphomas
Status:
COMPLETED
Status Verified Date:
2017-07
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:
The current standard treatment for non-Hodgkins lymphoma involves drugs called cyclophosphamide doxorubicin vincristine prednisone and rituxan in a regimen called R-CHOP Using R-CHOP therapy complete disappearance of disease is expected in over 50 of people One of the active drugs in the R-CHOP regimen doxorubicin has previously been reformulated and been placed in a fatty bubble called a liposome The reason for placing the drug in the liposome is that there is evidence that the liposome is better taken up by tumors This liposomally encapsulated form of doxorubicin called Doxil has shown similar or better anti-tumor against certain tumors with reduced side effects Doxil is FDA approved for ovarian cancer However its use in non-Hodgkins lymphoma is still investigational By substituting Doxil for doxorubicin in the R-CHOP regimen it is hoped this treatment will be better at shrinking tumors and with reduced side effects The purpose of this study is to see how well the combination of Doxil rituximab cyclophosphamide vincristine and prednisone DR-COP are in shrinking tumors in patients with non-Hodgkins lymphoma
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None