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

Phase 3

Completed

• Conditions: Follicular Lymphoma
• Interventions: Biological: rituximab; Biological: GP2013

• Registration Number: NCT01419665
• Lead Sponsor: Sandoz

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-17
• Study First Submitted QC: 2011-08-17
• Study First Posted: 2011-08-18
• Study Start: 2011-12-01
• Primary Completion: 2015-07-10
• Study Completion: 2018-01-22
• Results First Submitted: 2019-03-05
• Status Verified: 2021-04
• Results First Submitted QC: 2021-04-22
• Last Update Submitted: 2021-04-22
• Results First Posted: 2021-05-14
• Last Update Posted: 2021-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 629

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rituximab	rituximab	Type: Biological/Vaccine
GP2013	GP2013	Type: Biological/Vaccine

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)	24 weeks	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.

Secondary Outcome Measures

Name	Time	Method
To Evaluate the Progression Free Survival (PFS) With up to 3 Years of Follow-up Post Randomization	3 years	Number of participants with progression free survival events
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 Incidence of Immunogenicity (ADA Formation) Against GP2013 and MabThera (Rituximab)	24 weeks, 3 years	number of participants with confirmed positive ADA
To Evaluate a PK Marker Following the Treatment With GP2013-Chemotherapy and MabThera-Chemotherapy (C Max)	day 63	C max; For descriptive purposes only, no hypothesis testing
To Evaluate a PK Marker Following the Treatment With GP2013-Chemotherapy and MabThera-Chemotherapy (C Trough)	day 63	C through; For descriptive purposes only, no hypothesis testing
To Evaluate a PD Marker (Peripheral CD19+ B-cell Counts) Following the Treatment With GP2013 + Chemotherapy Amd MabThera- Chemotherapy	21 days	AUEC (0-21d); For descriptive purposes only, no hypothesis testing
To Evaluate the Overall Survival (OS) With up to 3 Years of Follow-up Post Randomization, as Assessed by the Number of Deaths	3 years	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.

Trial Locations

Locations (6)

Investigtive site; 🇮🇳 Kolkata, India

Investigative Site; 🇧🇷 Rio de Janeiro, Brazil

India; 🇮🇳 Amritsar, India

Investigative site; 🇬🇧 Worthing, United Kingdom

Investigator site; 🇧🇷 Barretos, Brazil

Invstigative site; 🇯🇵 Omura, Japan