Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-03-06 @ 2:53 AM
Study NCT ID:
NCT03976102
Status:
COMPLETED
Last Update Posted:
2024-01-22
First Post:
2019-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Compare Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) With MabThera® in LTB Follicular Lymphoma
Sponsor:
Dr. Reddy's Laboratories Limited
Organization:
Study Overview
Official Title:
A Double-blind, Parallel-group, Phase III Study to Compare the Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) With MabThera® in Subjects With Previously Untreated (CD)20-Positive LTB Follicular Lymphoma
Status:
COMPLETED
Status Verified Date:
2024-01
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:
FLINTER
Brief Summary:
The primary objective of the current study is to demonstrate the equivalent efficacy of rituximab (DRL\_RI) and MabThera® in subjects with Low Tumor Burden Follicular Lymphoma (LTB-FL).
Also evaluated by Pharmacokinetic, safety, and immunogenicity assessment between a proposed biosimilar (DRL\_RI) and the RMP, as an component of clinical study program, and collectively providing the evidence of biosimilarity.
The study will compare the safety and efficacy of DRL\_RI vs MabThera in patients with Low Tumor Burden Follicular Lymphoma (LTB-FL). The primary objective is to establish comparative efficacy as measured by ORR up to week 28
Also evaluated by Pharmacokinetic, safety, and immunogenicity assessment between a proposed biosimilar (DRL\_RI) and the RMP, as an component of clinical study program, and collectively providing the evidence of biosimilarity.
The study will compare the safety and efficacy of DRL\_RI vs MabThera in patients with Low Tumor Burden Follicular Lymphoma (LTB-FL). The primary objective is to establish comparative efficacy as measured by ORR up to week 28
Detailed Description:
It is planned to randomise approx. 312 subjects at approximately ≥ 130 study sites worldwide. Subjects with LTB-FL will be randomized to receive either DRL\_RI or MabThera®. Till date, 68 patients have been randomized for the study.
The study specific objectives are mentioned below:
Primary Objective:
• To demonstrate the equivalent efficacy of DRL\_RI (biosimilar rituximab) and MabThera in subjects with CD20-positive, LTB FL, as measured by overall response rate (ORR) up to Week 28 evaluated in accordance with Cheson, 1999 response criteria for Non-Hodgkin's Lymphomas.
Secondary Objectives:
* To compare the progression-free survival (PFS), overall survival (OS), and duration of response (DOR) of DRL\_RI with MabThera® in subjects with CD20-positive, LTB FL.
* To compare the safety, tolerability, and immunogenicity of DRL\_RI with MabThera in subjects with CD20-positive, LTB-FL.
Exploratory Objectives
* To explore the pharmacokinetic (PK) parameters of DRL\_RI and MabThera, using a population-PK modelling approach.
* To explore the pharmacodynamic parameters of DRL\_RI and MabThera.
The study specific objectives are mentioned below:
Primary Objective:
• To demonstrate the equivalent efficacy of DRL\_RI (biosimilar rituximab) and MabThera in subjects with CD20-positive, LTB FL, as measured by overall response rate (ORR) up to Week 28 evaluated in accordance with Cheson, 1999 response criteria for Non-Hodgkin's Lymphomas.
Secondary Objectives:
* To compare the progression-free survival (PFS), overall survival (OS), and duration of response (DOR) of DRL\_RI with MabThera® in subjects with CD20-positive, LTB FL.
* To compare the safety, tolerability, and immunogenicity of DRL\_RI with MabThera in subjects with CD20-positive, LTB-FL.
Exploratory Objectives
* To explore the pharmacokinetic (PK) parameters of DRL\_RI and MabThera, using a population-PK modelling approach.
* To explore the pharmacodynamic parameters of DRL\_RI and MabThera.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: