Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00268853
Status:
COMPLETED
Last Update Posted:
2024-05-30
First Post:
2005-12-21
Brief Title:
A Trial in Patients With Diffuse Large-B-cell Lymphoma Comparing Pixantrone Against Doxorubicin
Sponsor:
CTI BioPharma
Organization:
CTI BioPharma
Study Overview
Official Title:
Cyclophosphamide Doxorubicin Vincristine Prednisone Plus Rituximab CHOP-R and Cyclophosphamide Pixantrone Vincristine Prednisone Plus Rituximab CPOP-R in Patients With Diffuse Large-B-cell Lymphoma A Phase II Randomized Multicenter Comparative Trial
Status:
COMPLETED
Status Verified Date:
2024-05
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:
RAPID
Brief Summary:
The purpose of this study is to compare the standard CHOP-R regimen of Cyclophosphamide Doxorubicin Vincristine Prednisone and Rituximab to CPOP-R same regimen but substituting Doxorubicin with Pixantrone The objective is to show that CPOP-R is not inferior to CHOP-R
Detailed Description:
In preclinical studies pixantrone has shown significantly less cardiotoxicity than other anthracyclines or anthracenediones In addition patients with relapsed disease who have received prior maximum doses of anthracyclines have tolerated high doses of pixantrone with minimal added cardiotoxicity Pixantrone is currently being studied in a Phase III study in 3rd line aggressive NHL
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