Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Follicular

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Follicular Lymphoma

All Drugs and Chemicals

Antineoplastic Agents

Antirheumatic Agents

Antibodies

Vaccines

Rituximab

Immunoglobulins

Antineoplastic Agents, Immunological

Immunologic Factors

GP2013

rituximab

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.

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.

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

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

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.

Number of participants with progression free survival events

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.

number of participants with confirmed positive ADA

C max

For descriptive purposes only, no hypothesis testing

C through

For descriptive purposes only, no hypothesis testing

AUEC (0-21d)

For descriptive purposes only, no hypothesis testing

Novartis Pharmaceuticals

Sandoz

Safety follow-up (treatment emergent AE/SAEs): after discontinuation of study treatment, all subjects were followed for safety for 30 days for combination phase and 90 for maintenance/open label phase.

Combination GP2013+CVP

Combination MabThera+CVP

Maintenance GP2013

Maintenance MabThera

Total

Age, Continuous

Sex: Female, Male

Asian

Black

Caucasian

Native American

Other

Race/Ethnicity, Customized

Chinese

Hispanic / Latino

Indian (Indian Subcontinent)

Mixed Ethnicity

Unknown / missing

Japanese

Study Director

per protocol set, participants with measure

Overall Response Rate (ORR)

To Evaluate the Complete Response (CR) Rate During the Combination Treatment Period

To Evaluate the Partial Response (PR) Rate During the Combination Treatment Period

To Evaluate the Progression Free Survival (PFS) With up to 3 Years of Follow-up Post Randomization

To Evaluate the Overall Survival (OS) With up to 3 Years of Follow-up Post Randomization, as Assessed by the Number of Deaths

end of treatment combination phase (24 weeks)

end of treatment manintenance phase (3 years)

immunogenicity set, participants with measure

To Evaluate the Incidence of Immunogenicity (ADA Formation) Against GP2013 and MabThera (Rituximab)

pharmacokinetic analysis set 1, participants with measure

To Evaluate a PK Marker Following the Treatment With GP2013-Chemotherapy and MabThera-Chemotherapy (C Max)

To Evaluate a PK Marker Following the Treatment With GP2013-Chemotherapy and MabThera-Chemotherapy (C Trough)

Pharmnacodynamic analysis set, participants with measure

To Evaluate a PD Marker (Peripheral CD19+ B-cell Counts) Following the Treatment With GP2013 + Chemotherapy Amd MabThera- Chemotherapy

on treatment death

on treatment deaths maintenance

all deaths

On treatment deaths were collected from the start of treatment up to 30 days after study drug discontinuation, for a maximum duration of 30 months (treatment duration ranged from 90 to 782 days) Deaths post treatment survival follow up were collected after the on- treatment period, up to 3 years.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
GP2013 in the Treatment of Patients With Previously Untreated, Advanced Stage Follicular Lymphoma (ASSIST_FL)	NCT01419665	Follicular Lymp...	GP2013 rituximab	18 Years -	Sandoz
GP2013 in the Treatment of Patients With Previously Untreated, Advanced Stage Follicular Lymphoma (ASSIST_FL)	NCT01419665	Follicular Lymp...	GP2013 rituximab	18 Years -	Sandoz

Spots Global Cancer Trial Database for gp2013

Every month we try and update this database with for gp2013 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for gp2013

Every month we try and update this database with for gp2013 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for gp2013 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.