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

NCT02787239•Shanghai Henlius Biotech

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

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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 2.
•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.

Locations (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China

Key Dates

Start Date

October 1, 2015

Primary Completion Date

May 1, 2018

Completion Date

May 1, 2018

Last Updated

May 9, 2022

Enrollment

407

ACTUAL participants

Conditions

B-cell Non Hodgkin's Lymphoma

Interventions

HLX01

DRUG

Rituximab

DRUG

CHOP

DRUG

A Pharmacokinetic Study Comparing SCT400 And Rituximab in Patients With B-cell Non-Hodgkin's Lymphoma

NCT02456207

B-cell Non Hodgkin's Lymphoma

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 9, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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