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

Shanghai Henlius Biotech1 site in 1 country407 target enrollmentOctober 2015

ConditionsB-cell Non Hodgkin's Lymphoma

InterventionsRituximab HLX01 CHOP

DrugsHLX01 Rituximab CHOP

Overview

Phase: Phase 3
Intervention: Rituximab
Conditions: B-cell Non Hodgkin's Lymphoma
Sponsor: Shanghai Henlius Biotech
Enrollment: 407
Locations: 1
Primary Endpoint: Percentage of Participants With Overall Response Rate (ORR)
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

October 2015

End Date

May 2018

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shanghai Henlius Biotech

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Untreated CD20-positive DLBCL confirmed.
•IPI score of 1 to 2, Stage I \~ IV, Score 0 needs to accompanied by bulky disease, which is defined as the presence of a tumor mass with a diameter of more than 7.5 cm.
•ECOG performance status of 0 to
•More than 6 months life expectancy.
•At least one measurable lesion: For nodal tumor mass, more than 1.5 cm in the long axis and more than 1.0 cm in the short axis; For extranodal tumor mass, more than 1.0 cm in the long axis.
•18 years to 70 years; Male or female patients.

Exclusion Criteria

•Known allergic reactions against human or murine monoclonal antibody, murine products, or foreign proteins.
•Known allergic reactions against any component of CHOP regimen.
•Previous treatment for NHL, including chemotherapy, immunotherapy, partial radiotherapy for lymphoma, monoclonal antibody therapy or surgical treatment (excluding lymph node biopsies and surgical resection for non-lymphoma lesions).
•History of cytotoxic drugs treatment or anti-CD20 monoclonal antibody treatment for other disease (e.g., rheumatoid arthritis).
•Prior use of any monoclonal antibody within 3 months.
•Primary central nervous system(CNS) lymphoma, secondary CNS involvement, grey zone lymphoma (GZL) between burkitt and DLBCL, primary effusion lymphoma, plasmablastic lymphoma, primary cutaneous DLBCL, anaplastic lymphoma kinase(ALK) positive DLBCL or transformed lymphoma.