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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02787239
Recruitment Status : Completed
First Posted : June 1, 2016
Last Update Posted : May 8, 2019
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
B-cell Non Hodgkin's Lymphoma Drug: HLX01 Drug: Rituximab Drug: CHOP Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 407 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : October 2015
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab

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



Primary Outcome Measures :
  1. Percentage of Participants With Overall Response Rate (ORR) [ Time Frame: 18 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02787239


Locations
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China
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China
Sponsors and Collaborators
Shanghai Henlius Biotech
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Responsible Party: Shanghai Henlius Biotech
ClinicalTrials.gov Identifier: NCT02787239    
Other Study ID Numbers: HLX01-NHL03
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: September 2018
Additional relevant MeSH terms:
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Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents