Compare Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) With MabThera® in LTB Follicular Lymphoma
Condition: Follicular Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular
Intervention: DRL_RI (Proposed rituximab biosimilar); MabThera®
Intervention description: Proposed rituximab biosimilar, 100mg and 500mg, concentrate for solution for infusion; Reference product rituximab, 100mg and 500mg, concentrate for solution for infusion
Intervention MeSH terms: Rituximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Clinical Phase III, randomised, multicentre, double-blind study to demonstrate the equivalence of DRL_RI to MabThera® in subjects with previously untreated, LTB-FL.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 317.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Follicular Lymphoma; Dr. Reddy's Rituximab; Biosimilar (DRL_RI); FLINTER

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
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject is Male or female subjects aged ≥18 years of age.

          2. Subject is histologically confirmed, Grade 1-3a, previous ly untreated, CD20-pos
             itive.

          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 d'Etude des Lymphomes
             Folliculaires (GELF) Criteria

          5. Subject has at least 1 measurable tumor mass in 2 dimensions, and the mass must be:

               1. Nodal lesion >15 mm in the longest dimension; or

               2. Noda l lesion >10 mm to he longest dimension; dimens ion and >10 mm in the
                  shortest dimension; or

               3. Extra-nodal lesion with both long and short dimensions ≥10 mm.

          6. Subject has Life expectancy ≥3 months.

          7. If female subject, then subject should be non-pregnant, non-lactating.

        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 sero-positivity for or history of active viral infection with
             human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) will be
             excluded. And if positive for hepatitis B core antibody or hepatitis C virus (HCV)
             antibody can only be enrolled if HBV - DNA level <20 IU/mL (or 112 copies/mL) and HCV
             - RNA is negative respectively by PCR test..

          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
             Investigator's 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.