CTRI/2019/05/019044 [Registered on: 10/05/2019] Trial Registered Prospectively
Last Modified On:
Post Graduate Thesis
Type of Trial
Type of Study
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A clinical trial to compare the effects of two drugs DRL_RI and MabThera® for treatment in subjects with low tumor burden of follicular lymphoma (cancer of the immune system), who were not treated earlier.
Scientific Title of Study
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
DRL_rituximab (DRL_RI) will be administered as an intravenous (i.v) infusion, at a dose of 375 mg/m2 of Body Surface Area.
MabThera® will be administered as an intravenous (i.v) infusion, at a dose of 375 mg/m2 of Body Surface Area.
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 greater than 10 mm to the longest dimension; dimens ion and greater than 10 mm in the shortest dimension; or
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 sero-positivity 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.
7)Subjects who have received a live vaccine within last 3 months of the first administration of study drug.
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).
10)Women of childbearing potential who do not consent to use highly effective methods of birth control
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Participant and Investigator Blinded
To demonstrate the equivalent efficacy of DRL_RI and MabThera® in subjects as measured by Overall Response Rate evaluated in accordance with published response criteria for malignant lymphoma.
Progression-free survival (PFS)
Week 52/ till progressive disease/ death
Overall Response Rate
Week 52/ End of study
Duration of response
Week 52/ End of study
Safety, tolerability, and immunogenicity of DRL_RI and MabThera®
Target Sample Size
Total Sample Size="284" Sample Size from India="66" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
The primary objective of the current study is to demonstrate the equivalent efficacy of DRL_RI and MabThera® in subjects with cluster of differentiation (CD)20-positive, low tumour burden follicular lymphoma (LTB-FL) in the first-line treatment setting, as measured by overall response rate (ORR).