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

Phase 3

Completed

• Conditions: B-cell Non Hodgkin's Lymphoma
• Interventions: Drug: HLX01; Drug: Rituximab; Drug: CHOP

• Registration Number: NCT02787239
• Lead Sponsor: Shanghai Henlius Biotech

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2016-05-18
• Study First Submitted QC: 2016-05-25
• Study First Posted: 2016-06-01
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-04
• Last Update Posted: 2022-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 407

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HLX01	CHOP	375mg/m2 iv q3w, 6 cycles(each cycle is 3 weeks)
HLX01	HLX01	375mg/m2 iv q3w, 6 cycles(each cycle is 3 weeks)
Rituximab	Rituximab	375mg/m2 iv q3w, 6 cycles(each cycle is 3 weeks)
Rituximab	CHOP	375mg/m2 iv q3w, 6 cycles(each cycle is 3 weeks)

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Overall Response Rate (ORR)	18 weeks

Trial Locations

Locations (1)

Cancer Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China