A Randomised, 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, Stage II-IV, Cluster of Differentiation (CD)20-Positive, Low Tumour Burden Follicular Lymphoma - FLINTER

Dr Reddys Laboratories SA0 sites33 target enrollmentTBD

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Health Condition 1: C820- Follicular lymphoma grade IHealth Condition 2: C821- Follicular lymphoma grade IIHealth Condition 3: C823- Follicular lymphoma grade IIIa
Sponsor: Dr Reddys Laboratories SA
Enrollment: 33
Status: Completed
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

TBD

End Date

February 23, 2023

Last Updated

2 years ago

Study Type

Interventional

Sponsor

Dr Reddys Laboratories SA

•1\)Subject is Male or female subjects aged greater than or equals to 18 years of age.
•2\)Subject is histologically confirmed, Grade 1\-3a, previously untreated, CD20\-positive.
•3\)Subject has Ann Arbor Stage II to IV and ECOG status of 0 to 1\.
•4\)Subject has Low tumor burden follicular lymphoma as per Groupe dEtude des Lymphomes Folliculaires (GELF) Criteria
•5\)Subject has at least 1 measurable tumor mass in 2 dimensions, and the mass must be:
•a) Nodal lesion greater than 15 mm in the longest dimension; or
•b) Nodal lesion \>10 mm to less than or equals to 15 mm in the longest dimension and \>10 mm in the shortest dimension
•c) Extra\-nodal lesion with both long and short dimensions greater than or equals to 10 mm.
•6\)Subject has Life expectancy greater than or equals to 3 months.
•7\)If female subject, then subject should be non pregnant, non lactating.

•1\)Subject with prior use of rituximab or any CD20 monoclonal antibody for any reason.
•2\)Subjects with known hypersensitivity to rituximab or its excipients, or to proteins of murine or other foreign origin.
•3\)Any prior therapy for follicular lymphoma (including but not limited to chemotherapy, radiotherapy) or subjects on chronic supra\-substitutive doses of systemic gluco\-corticosteriods.
•4\)Subjects who, in the opinion of the Investigator, require additional concomitant treatment for lymphoma.
•5\)Evidence of histologic transformation to high grade lymphoma or diffuse large B\-cell lymphoma.
•6\) Subjects with known seropositivity for or history of active viral infection with human immunodeficiency virus (HIV).
•Subjects with positive serological test for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C virus (HCV) antibody can only be included in the study only if the criteria mentioned in the protocol are met.
•7\) Subjects who received a live vaccine within last 3 months of the first administration of study drug except vaccine against COVID\-19\.
•8\)Subjects with history or presence of a medical condition or disease that in the Investigators opinion would place the subject at an unacceptable risk for study participation.
•9\)Participation in any clinical study or having taken any investigational therapy (within 2 months of the first dose of study drug).