Health Condition 1: C820- Follicular lymphoma grade I Health Condition 2: C821- Follicular lymphoma grade II Health Condition 3: C823- Follicular lymphoma grade IIIa
Conditions
Interventions
Intervention1: DRL_rituximab (DRL_RI): DRL_rituximab (DRL_RI) will be administered as an intravenous (i.v) infusion, at a dose of 375 mg/m2 of Body Surface Area.
Control Intervention1: MabThera®: MabT
Sponsors
Dr Reddys Laboratories SA
PAREXEL International Clinical Research Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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). 10)Women of childbearing potential who do not consent to use highly effective methods of birth control
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: up to Week 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete ResponseTimepoint: As a best response up to Month 7 (Week 28);Duration of responseTimepoint: Week 52/ End of study;Overall Response RateTimepoint: Week 12 and Week 28;Overall SurvivalTimepoint: Week 52/ End of study;Progression-free survival (PFS)Timepoint: Week 52/ till progressive disease/ death;Safety, tolerability, and immunogenicity of DRL_RI and MabThera®Timepoint: Week 52 | — |
Countries
Belarus, Bosnia and Herzegovina, Bulgaria, Czech Republic, Georgia, Greece, India, Italy, Poland, Republic of Korea, Romania, Russian Federation, Serbia, Spain, Turkey, Ukraine, United States of America
Contacts
Public ContactDr Annappa Kamath
PAREXEL International Clinical Research Private Limited
Outcome results
None listed