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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

Primary Purpose

B-cell Non Hodgkin's Lymphoma

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
HLX01
Rituximab
CHOP
Sponsored by
Shanghai Henlius Biotech
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B-cell Non Hodgkin's Lymphoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Cancer Hospital, Chinese Academy of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HLX01

Rituximab

Arm Description

375mg/m2 iv q3w, 6 cycles(each cycle is 3 weeks)

375mg/m2 iv q3w, 6 cycles(each cycle is 3 weeks)

Outcomes

Primary Outcome Measures

Percentage of Participants With Overall Response Rate (ORR)

Secondary Outcome Measures

Full Information

First Posted
May 18, 2016
Last Updated
May 4, 2022
Sponsor
Shanghai Henlius Biotech
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1. Study Identification

Unique Protocol Identification Number
NCT02787239
Brief Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Henlius Biotech

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-cell Non Hodgkin's Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
407 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HLX01
Arm Type
Experimental
Arm Description
375mg/m2 iv q3w, 6 cycles(each cycle is 3 weeks)
Arm Title
Rituximab
Arm Type
Active Comparator
Arm Description
375mg/m2 iv q3w, 6 cycles(each cycle is 3 weeks)
Intervention Type
Drug
Intervention Name(s)
HLX01
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Type
Drug
Intervention Name(s)
CHOP
Primary Outcome Measure Information:
Title
Percentage of Participants With Overall Response Rate (ORR)
Time Frame
18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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 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.
Facility Information:
Facility Name
Cancer Hospital, Chinese Academy of Medical Sciences
City
Beijing
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
32299513
Citation
Shi Y, Song Y, Qin Y, Zhang Q, Han X, Hong X, Wang D, Li W, Zhang Y, Feng J, Yang J, Zhang H, Jin C, Yang Y, Hu J, Wang Z, Jin Z, Su H, Wang H, Yang H, Fu W, Zhang M, Zhang X, Chen Y, Ke X, Liu L, Yu D, Chen G, Wang X, Jin J, Sun T, Du X, Cheng Y, Yi P, Zhao X, Ma C, Cheng J, Chai K, Luk A, Liu E, Zhang X. A phase 3 study of rituximab biosimilar HLX01 in patients with diffuse large B-cell lymphoma. J Hematol Oncol. 2020 Apr 16;13(1):38. doi: 10.1186/s13045-020-00871-9.
Results Reference
result
Links:
URL
https://doi.org/10.1093/annonc/mdy437.005
Description
286PFirst china-manufactured proposed rituximab biosimilar met primary efficacy and safety endpoints in CD20-positive diffuse large B-cell lymphoma (generics). Annals of Oncology 2018, 29 (suppl_9), mdy437.005-mdy437.005
URL
https://doi.org/10.1182/blood-2019-130603
Description
First China Approved Rituximab Biosimilar HLX01: Pharmacokinetics, Safety and Efficacy Comparison to Reference Rituximab in the Phase 3 Diffuse Large B-Cell Lymphoma Study. Blood 2019, 134 (suppl_1), 2878.
URL
https://doi.org/10.1093/annonc/mdz251.015
Description
A new population model validated pharmacokinetic similarity of HLX01 and rituximab in B-cell lymphoma. Annals of Oncology 2019, 30.
URL
https://doi.org/10.1093/annonc/mdz427
Description
266OA population pharmacokinetic model: Assessment of pharmacokinetic similarity of HLX01 and rituximab in diffuse large B-cell lymphoma. Annals of Oncology 2019, 30 (suppl_9), mdz427.

Learn more about this trial

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

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