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.
Sponsor: Dr. Reddy’s Laboratories S.A. CRO: PAREXEL. Data manager: Eva Díez.
- Primary Objective:
- To demonstrate the equivalent efficacy of DRL_RI and MabThera® in subjects with CD20-positive, low tumour burden follicular lymphoma LTB-FL in the first-line treatment setting, as measured by ORR.
- Drug
- DRL_RI: chimeric (human/murine) anti-CD20 monoclonal antibody
- DRL_RI or MabThera® will be administered as an i.v infusion, at a dose of 375 mg/m2. Subjects will receive induction treatment consisting of weekly i.v infusions up to Week 4 (4 cycles), followed by maintenance treatment consisting of an i.v infusion every 8 weeks from Week 12 up to Week 36 (4 cycles). Follow-up period Week 52.
- Design
- Randomisation will be stratified by low, medium, and high-risk subjects using FLIPI2), as well as by tumour grade (1-2 Vs. 3a).
- Inclusion Criteria
- Histologically confirmed, Grade 1-3a, previously untreated, CD20-positive, LTB-FL as per GELF based criteria.
- Exclusion Criteria
- Prior use of rituximab or any CD20 mAb for any reason. Any prior therapy for FL (including radiotherapy).
- Seropositivity for or history of active viral infection with HIV, HBsAg positive or HBcAb positive, HCV Ab positive.
- Screening (Days -35 to -1):
- Subjects must have tissue available for the central pathology review and a centrally-confirmed diagnosis prior to being randomised
- CT scan and PET-CT (where available).
- Bone marrow biopsy (if no previous biopsy within the last 12 weeks before dosing is available).
- Pharmacokinetics
Schedule of Visits and Assessments:
- Induction Treatment Period: Study Days 1, 8, 15, and 22 [Week 1 to Week 4 ± 2 days
- Maintenance Treatment Period (Week 12 to Week 36 ± 7 days)
Alejandro Martín García-Sancho (amartingar@usal.es)
Norma Gutiérrez Gutiérrez (normagu@usal.es)
Dolores Caballero Barrigón (cabarri@usal.es)
Hospital Universitario de Salamanca, IBSAL, CIBERONC
