NCT02747043

Study to Assess if ABP798 is Safe & Effective in Treating Non Hodgkin Lymphoma Compared to Rituximab

A Randomized, Double-Blind Study Evaluating the Efficacy, Safety and Immunogenicity of ABP 798 Compared With Rituximab in Subjects With CD20 Positive B-Cell Non-Hodgkin Lymphoma (NHL)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 256 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This was a randomized, double-blind, active-controlled, multiple-dose, clinical similarity study to evaluate the efficacy, pharmacokinetics, pharmacodynamics, safety, tolerability and immunogenicity of ABP 798 compared with rituximab in subjects with grade 1, 2, or 3a follicular B-cell NHL and low tumor burden. Subjects were randomized in a 1:1 ratio to receive a 375 mg/m\^2 intravenous infusion of either ABP 798 or rituximab once weekly for 4 weeks followed by dosing at weeks 12 and 20.

Conditions

• Lymphoma, Non-Hodgkin

Interventions

Type	Name	Description
BIOLOGICAL	ABP 798	ABP 798 was supplied as a sterile, preservative-free liquid concentrate for IV infusion at a concentration of 10 mg/mL in either 100 mg/10 mL or 500 mg/50 mL single-dose vials. Subjects were to receive premedications before each infusion. Premedications were to be given according to local practice for administration of rituximab therapy.
BIOLOGICAL	Rituximab	Rituximab was procured from commercial supplies in the US and was supplied as a sterile, clear, colorless, preservative-free liquid concentrate for IV infusion at a concentration of 10 mg/mL in either 100-mg/10 mL or 500-mg/50 mL single-dose vials. Subjects were to receive premedications before each infusion. Premedications were to be given according to local practice for administration of rituximab therapy.

Timeline

• Start date: 2016-05-25
• Primary completion: 2019-06-28
• Completion: 2019-06-28
• First posted: 2016-04-21
• Last updated: 2022-09-10
• Results posted: 2020-08-18

Locations

98 sites across 20 countries: United States, Australia, Bulgaria, Canada, Colombia, Czechia, France, Georgia, Germany, Greece, India, Israel, Italy, Japan, Mexico, Poland, Romania, South Korea, Spain, Ukraine