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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

H

Henlius Pharmaceuticals

Status and phase

Completed
Phase 3

Conditions

B-cell Non Hodgkin's Lymphoma

Treatments

Drug: Rituximab
Drug: CHOP
Drug: HLX01

Study type

Interventional

Funder types

Industry

Identifiers

NCT02787239
HLX01-NHL03

Details and patient eligibility

About

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

Enrollment

407 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

407 participants in 2 patient groups

HLX01
Experimental group
Description:
375mg/m2 iv q3w, 6 cycles(each cycle is 3 weeks)
Treatment:
Drug: HLX01
Drug: CHOP
Rituximab
Active Comparator group
Description:
375mg/m2 iv q3w, 6 cycles(each cycle is 3 weeks)
Treatment:
Drug: CHOP
Drug: Rituximab

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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