GP2013 in the Treatment of Patients With Previously Untreated, Advanced Stage Follicular Lymphoma (ASSIST_FL)

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Controlled, Double-Blind Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of GP2013 vs. MabThera® in Patients With Previously Untreated, Advanced Stage Follicular Lymphoma

Conditions
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Follicular Lymphoma

Intervention / Treatment
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* Biological: GP2013
* Biological: rituximab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with previously untreated advanced stage, CD20-positive FL Patient with ECOG performance status 0, 1 or 2. Exclusion Criteria: Patient with Grade 3b (aggressive) FL or any histology other than FL grade 1, 2 or 3a Patient who has previously received any prior therapy for lymphoma Patient with evidence of any uncontrolled, active infection (viral, bacterial or fungal). Patient with any malignancy within 5 years prior to date of randomization, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer. Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A subset of patients is switched from GP2013 to MabThera or continued with MabThera during the maintenance phase, for these patients the treatment is finished as an open labeled parallel arm study. The original treatment assignment is kept blinded.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GP2013<br>Type: Biological/Vaccine | Biological: GP2013<br>* Type: Biological/Vaccine<br>* Other names: no brand name available;|
| Active Comparator: rituximab<br>Type: Biological/Vaccine | Biological: rituximab<br>* Type: Biological/Vaccine<br>* Other names: MabThera(R);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Evaluate the Complete Response (CR) Rate During the Combination Treatment Period |  | 24 weeks | 
| To Evaluate the Partial Response (PR) Rate During the Combination Treatment Period |  | 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 | 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. | 3 years | 
| To Evaluate the Incidence of Immunogenicity (ADA Formation) Against GP2013 and MabThera (Rituximab) | number of participants with confirmed positive ADA | 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 | day 63 | 
| 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 | 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 | 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Follicular Lymphoma, Biosimilar, GP13-301, rituximab, Antibodies, CD20