Clinical Study to Compare the Efficacy and Safety of Rituximab Biosimilar HLX01 and Rituximab in Combination With CHOP, in Previously Untreated Subjects With CD20+ DLBCL
- Sponsor
- Shanghai Henlius Biotech
- Study ID
- NCT02787239
- Phase
- PHASE3
- Status
- Completed
Conditions
- B-cell Non Hodgkin's Lymphoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- HLX01 — DRUG
- Rituximab — DRUG
- CHOP — DRUG
Study Details
Multicenter, Randomized, Double-blind, Parallel, Phase III Clinical Study to Compare the Efficacy and Safety of Rituximab Biosimilar HLX01 and MabThera in Combination With CHOP, in Previously Untreated Subjects With CD20+ DLBCL
Key Dates
- Start date
- Oct 31, 2015
- Status verified
- May 2022
- Primary completion
- May 31, 2018
- Completion
- May 31, 2018
Study Design
- Enrollment
- 407 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: HLX01375mg/m2 iv q3w, 6 cycles(each cycle is 3 weeks)
- Active Comparator: Rituximab375mg/m2 iv q3w, 6 cycles(each cycle is 3 weeks)
Primary Outcome Measure
Percentage of Participants With Overall Response Rate (ORR) [ Time Frame: 18 weeks ]