To Demonstrate Equivalence of Pharmacokinetics and Noninferiority of Efficacy for CT-P10 in Comparison With Rituxan

Inclusion criteria

• Patient is male or female older than 18 years.
• Patient has histologically confirmed FL according to the World Health Organization 2008 classification (Jaffe 2009); grades 1 to 3a based on local laboratory review.
• Patient has at least 1 measurable tumour mass that has not previously been irradiated, and the mass must be:

• greater than 1.5 cm in the longest dimension or
• between 1.1 and 1.5 cm in the longest dimension and greater than 1.0 cm in the shortest axis
• Patient has confirmed CD20+ lymphoma, as assessed by local laboratory review. (Tissue obtained within 6 months before Day 1 of Cycle 1 will be reviewed by a central independent reviewer to detect pathological type.)
• Patient has Ann Arbor stage III or IV disease.

Exclusion criteria

• Patient has received rituximab (or a rituximab biosimilar), cyclophosphamide, or vincristine.
• Patient has allergies or hypersensitivity to murine, chimeric, human or humanised proteins, cyclophosphamide, vincristine, or prednisone.
• Patient has evidence of histological transformation to high-grade or diffuse large B-cell lymphoma.
• Patient has known central nervous system involvement.
• Patient has received previous treatment for NHL:

• Previous treatment including chemotherapy, radiotherapy, immunotherapy, and/or surgery (except previous biopsy)
• All doses of corticoid therapy for treatment of NHL
• Corticoid therapy during the previous 4 weeks from Day 1 of Cycle 1 with prednisone >20 mg per day for the treatment for any purpose