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

Dr. Reddy’s Laboratories S.A.0 sites284 target enrollmentMay 27, 2019

DrugsMabThera

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Dr. Reddy’s Laboratories S.A.
Enrollment: 284
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 27, 2019

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Dr. Reddy’s Laboratories S.A.

Eligibility Criteria

Inclusion Criteria

•1\. Signed written informed consent.
•2\. Male or female subjects aged \=18 years of age.
•3\. Histologically confirmed, Grade 1\-3a, previously untreated, CD20\-positive, LTB\-FL as per Groupe D’Etude des Lymphomes Folliculaires (GELF) criteria. Subjects must have tissue available for the central pathology review, and a centrally\-confirmed diagnosis prior to being randomised. Should a subject be eligible as per the central imaging review but not as per the Study Centre Review the subject will be considered eligible if confirmed both by the Investigator and the Medical Monitor. For any other disagreement in eligibility the subject will be considered ineligible.
•4\. Ann Arbor Stage II to IV of histological Grade 1, 2, or 3a.
•5\. ECOG status of 0 to 1\.
•6\. Low tumour burden follicular lymphoma defined as:
•· As per central radiological assessment, nodal or extranodal mass involvement with diameter measuring \<7 cm
•· As per central radiological assessment, involvement of \<3 nodal sites with diameter measuring \>3 cm
•· Absence of systemic symptoms or B\-symptoms\* (asymptomatic)
•\*B\-symptoms defined as weight loss \>10% within last 6 months, recurrent or continuous night sweats, intermittent or continuous fever recorded as axillary or oral temperature \>38°C for at least 3 days

Exclusion Criteria

•1\. Prior use of rituximab or any CD20 monoclonal antibody for any reason.
•2\. Any contraindication to the use of rituximab.
•3\. Any prior therapy for follicular lymphoma (including but not limited to chemotherapy, radiotherapy).
•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\. Known Central Nervous System (CNS) involvement by lymphoma. (Note: CNS imaging is not required unless clinically indicated).
•7\. Subjects on chronic supra\-substitutive doses (defined as doses in excess of 7\.5 mg per day of prednis one or prednis one equivalent for a period longer than 3 weeks) of systemic glucocorticoids.
•8\. Prior malignancy, other than non\-melanoma skin cancer or intraepithelial cervical neoplasia, successfully treated more than 1 year before study inclusion.
•9\. Subjects with any of the following: known seropositivity for or history of active viral infection with human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) positive or hepatitis B core antibody positive, hepatitis C virus (HCV) antibody positive.
•10\. Subjects with active tuberculosis (TB). Subjects with evidence of latent TB or a history of TB must have completed treatment or have initiated treatment for at least 1 month before the first dose of study drug (Day 1\). Tuberculosis testing (QuantiFERON®\-TB Gold\-in\-Tube test \- QFT\-GIT or QuantiFERON®\-TB Gold Plus) is requested only if it is required by local regulations or practice.