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 Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Overall Response Rate (ORR) [18 weeks]
Eligibility Criteria
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.
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More than 6 months life expectancy.
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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.
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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).
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History of cytotoxic drugs treatment or anti-CD20 monoclonal antibody treatment for other disease (e.g., rheumatoid arthritis).
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Prior use of any monoclonal antibody within 3 months.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cancer Hospital, Chinese Academy of Medical Sciences | Beijing | China |
Sponsors and Collaborators
- Shanghai Henlius Biotech
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
- 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
- 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.
- A new population model validated pharmacokinetic similarity of HLX01 and rituximab in B-cell lymphoma. Annals of Oncology 2019, 30.
- 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.
Publications
None provided.- HLX01-NHL03