Ignite Creation Date:
2024-05-06 @ 3:19 AM
Last Modification Date:
2024-10-26 @ 11:32 AM
Study NCT ID:
NCT02268045
Status:
COMPLETED
Last Update Posted:
2019-09-26
First Post:
2014-09-19
Brief Title:
Study of RTXM83 Plus CHOP Chemotherapy Versus a Rituximab Plus CHOP Therapy in Patients With Non Hodgkins Lymphoma
Sponsor:
mAbxience Research SL
Organization:
mAbxience Research SL
Study Overview
Official Title:
A Randomized Double-blind Phase III Study Comparing Biosimilar Rituximab RTXM83 Plus CHOP Chemotherapy Versus a Reference Rituximab Plus CHOP R-CHOP in Patients With Diffuse Large B-cell Lymphoma DLBCL Given as First Line
Status:
COMPLETED
Status Verified Date:
2019-08
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:
This is a multicenter double-blind randomized study comparing the efficacy pharmacokinetics PKpharmacodynamics PD safety and immunogenicity profile of RTXM83 rituximab biosimilar vs reference rituximab MabThera both with CHOP as first-line treatment of Diffuse-Large-B-Cell-Lymphoma DLBCL
Rituximab biosimilar and MabThera were both administered intravenously on Day 1 of each 3-week cycle with CHOP chemotherapy for six cycles Two additional cycles of treatment were permitted at the Investigators discretion Patients were followed up for 9 months after last study dose
Rituximab biosimilar and MabThera were both administered intravenously on Day 1 of each 3-week cycle with CHOP chemotherapy for six cycles Two additional cycles of treatment were permitted at the Investigators discretion Patients were followed up for 9 months after last study dose
Detailed Description:
The primary endpoint of the investigation is to determine if the response rate obtained with RTXM83 combined with CHOP is non inferior to the response rate obtained with reference rituximab combined with CHOP
The present study is a non inferiority trial and the study hypothesis is the following H0 pc pe δ vs H1 pc pe δ where pe proportion of successes in the experimental group RTXM83CHOP pc proportion of successes in the control group Reference RituximabCHOP Type I error the difference pc-pe is less than δ when in fact the difference is greater than or equal to δ ie the investigators choose the experimental treatment when the control treatment is actually substantially better
Type II error the difference -pe is greater than or equal to δ when it is actually lest than δ ie the investigators choose the control treatment when the experimental treatment is essentially just as good
The present study is a non inferiority trial and the study hypothesis is the following H0 pc pe δ vs H1 pc pe δ where pe proportion of successes in the experimental group RTXM83CHOP pc proportion of successes in the control group Reference RituximabCHOP Type I error the difference pc-pe is less than δ when in fact the difference is greater than or equal to δ ie the investigators choose the experimental treatment when the control treatment is actually substantially better
Type II error the difference -pe is greater than or equal to δ when it is actually lest than δ ie the investigators choose the control treatment when the experimental treatment is essentially just as good
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