Compare Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) With MabThera® in LTB Follicular Lymphoma

Part of paid clinical trials in Whittier, California.

Sponsor
Dr. Reddy's Laboratories Limited
Study ID
NCT03976102
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DRL_RI (Proposed rituximab biosimilar) — BIOLOGICAL
    Proposed rituximab biosimilar, 100mg and 500mg, concentrate for solution for infusion
  • MabThera® — OTHER
    Reference product rituximab, 100mg and 500mg, concentrate for solution for infusion

Study Details

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

Key Dates

Start date
May 15, 2019
Status verified
Jan 2024
Primary completion
Sep 28, 2022
Completion
Feb 27, 2023

Study Design

Enrollment
317 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: DRL_RI
    DRL\_RI (rituximab-Dr. Reddy's Lab) for infusion 375 mg/m2 administered via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36
  • Active Comparator: Arm B: MabThera®
    MabThera® for infusion 375 mg/m2 administered via IV infusion on Days 1, 8, 15, 22 and Week 12, 20, 28 and 36.

Primary Outcome Measure

Best Overall Response Rate (BORR) for Low Tumor Burden Follicular Lymphoma [ Time Frame: Month 7 (Week 28) ]

Locations (4)

FacilityCityStateZIPSite coordinators
The Oncology Institute of Hope and InnovationWhittierCalifornia90602-
American Oncology Partners of MarylandBethesdaMaryland20817-
University of Tennessee Medical Center - Cancer InstituteKnoxvilleTennessee37920-
Gulf coast Oncology Associates, PAHoustonTexas77089-

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By research site
The Oncology Institute of Hope and Innovation· Whittier, CAAmerican Oncology Partners of Maryland· Bethesda, MDUniversity of Tennessee Medical Center - Cancer Institute· Knoxville, TNGulf coast Oncology Associates, PA· Houston, TX

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