The purpose of this study is to demonstrate comparability of the ORR in patients with previously untreated, advanced stage FL who receive GP2013-treatment to patients who receive MabThera-treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
629
Overall Response Rate (ORR)
ORR is defined as the proportion of patients whose best overall disease response was either CR or PR during the combination treatment period based on blinded independent central radiology review.
Time frame: 24 weeks
To Evaluate the Complete Response (CR) Rate During the Combination Treatment Period
Time frame: 24 weeks
To Evaluate the Partial Response (PR) Rate During the Combination Treatment Period
Time frame: 24 weeks
To Evaluate the Progression Free Survival (PFS) With up to 3 Years of Follow-up Post Randomization
Number of participants with progression free survival events
Time frame: 3 years
To Evaluate the Overall Survival (OS) With up to 3 Years of Follow-up Post Randomization, as Assessed by the Number of Deaths
OS was defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died, OS was censored at the date of last contact including survival follow-up.
Time frame: 3 years
To Evaluate the Incidence of Immunogenicity (ADA Formation) Against GP2013 and MabThera (Rituximab)
number of participants with confirmed positive ADA
Time frame: 24 weeks, 3 years
To Evaluate a PK Marker Following the Treatment With GP2013-Chemotherapy and MabThera-Chemotherapy (C Max)
C max For descriptive purposes only, no hypothesis testing
Time frame: day 63
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Investigative site
La Plata, Argentina
Investigative site
Rosario, Argentina
Investigative site
San Miguel de Tucumán, Argentina
Investigative site
Adelaide, Australia
Investigative site
Ballarat, Australia
Investigative site
Epping, Australia
Investigative site
Footscray, Australia
Investigative site
Wodonga, Australia
Investigative site
Graz, Austria
Investigative site
Vienna, Austria
...and 143 more locations
To Evaluate a PK Marker Following the Treatment With GP2013-Chemotherapy and MabThera-Chemotherapy (C Trough)
C through For descriptive purposes only, no hypothesis testing
Time frame: day 63
To Evaluate a PD Marker (Peripheral CD19+ B-cell Counts) Following the Treatment With GP2013 + Chemotherapy Amd MabThera- Chemotherapy
AUEC (0-21d) For descriptive purposes only, no hypothesis testing
Time frame: 21 days