Trial reportJournal of hematology & oncology2020
A phase 3 study of rituximab biosimilar HLX01 in patients with diffuse large B-cell lymphoma.
Trial report in Journal of hematology & oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 22 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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
A Single-arm, Multicenter Phase II Clinical Study of HiR+X Therapy for Newly Diagnosed Diffuse Large B-cell Lymphoma (DLBCL) in Elderly Patients Intolerant to Chemotherapy, Guided by Molecular Subtyping and Clinical Characteristics.
Who cites it
22 citing papers in PubMed, 4 syntheses or guidelines pooled it, 50 citations in OpenAlex.
- Biosimilar monoclonal antibodies for cancer treatment in adults.The Cochrane database of systematic reviews · 2024Pooled it
- Clinical Benefit, Price, and Uptake for Cancer Biosimilars vs Reference Drugs in China: A Systematic Review and Meta-Analysis.JAMA network open · 2023Pooled it
- Comparative Safety Profiles of Oncology Biosimilars: A Systematic Review and Network Meta-analysis.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2023Pooled it
- Characteristics of Clinical Trials Evaluating Biosimilars in the Treatment of Cancer: A Systematic Review and Meta-analysis.JAMA oncology · 2022Pooled it
- Comparison of zuberitamab plus CHOP versus rituximab plus CHOP for the treatment of drug-naïve patients diagnosed with CD20-positive diffuse large B-cell lymphoma: a phase 3 trial.Journal for immunotherapy of cancer · 2024Trial
- Quality of life assessment in diffuse large B-cell lymphoma (DLBCL) in REFLECT: a prospective, non-interventional, multicenter, German study, assessing Sandoz rituximab in combination with CHOP.Annals of hematology · 2024Trial
- Long-term outcomes with HLX01 (HanliKangBMC cancer · 2024Trial
- Efficacy and safety of HLX01 in patients with moderate-to-severe rheumatoid arthritis despite methotrexate therapy: a phase 3 study.Arthritis research & therapy · 2022Trial
- Efficacy and Safety of ABP 798: Results from the JASMINE Trial in Patients with Follicular Lymphoma in Comparison with Rituximab Reference Product.Targeted oncology · 2020Trial
- A retrospective study of the efficacy and safety of rituximab biosimilar for the treatment of membranous nephropathy.BMC pharmacology & toxicology · 2026Article
- Lighting the path against cancer with academic light: Forty years of growth with the Chinese Medical Association-Celebrating the 110th anniversary of the founding of the Chinese Medical Association.Cancer pathogenesis and therapy · 2025Article
- Effectiveness of rituximab and biosimilar rituximab in untreated diffuse large B-cell lymphoma, a Danish population-based analysis.British journal of haematology · 2025Article
- Cost-effectiveness of HLX01 (HanlikangFrontiers in pharmacology · 2025Article
- Monoclonal antibody biosimilars for cancer treatment.iScience · 2024Review
- Efficacy and safety of rituximab for primary membranous nephropathy with different clinical presentations: a retrospective study.Frontiers in immunology · 2023Article
- Clinical characteristics and treatment outcomes of Chinese diffuse large B-cell lymphoma patients in the era of rituximab (2005-2018).Cancer pathogenesis and therapy · 2023Article
- Biosimilar Rituximab (Redditux) Added to CHOP Chemotherapy for De Novo Diffuse Large B-Cell Lymphoma Patients: Real-Life Single-Center ExperienceTurkish journal of haematology : official journal of Turkish Society of Haematology · 2022Article
- Diffuse Large B-Cell Lymphoma in Chile: The Impact of Combined CHOP Plus Rituximab in the Public Health System.JCO global oncology · 2022Article
- An Introduction to Biosimilars for the Treatment of Retinal Diseases: A Narrative Review.Ophthalmology and therapy · 2022Review
- Phase 1 studies comparing safety, tolerability, pharmacokinetics and pharmacodynamics of HLX01 (a rituximab biosimilar) to reference rituximab in Chinese patients with CD20-positive B-cell lymphoma.Chinese journal of cancer research = Chung-kuo yen cheng yen chiu · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
41 authors at 20 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Rituximab in combination with chemotherapy has shown efficacy in patients with diffuse large B-cell lymphoma (DLBCL) for more than 15 years. HLX01 was developed as the rituximab biosimilar following a stepwise approach to demonstrate biosimilarity in analytical, pre-clinical, and clinical investigations to reference rituximab. With demonstrated pharmacokinetic similarity, a phase 3 multi-center, randomized, parallel, double-blind study (HLX01-NHL03) was subsequently conducted to compare efficacy and safety between HLX01 plus cyclophosphamide, doxorubicin, vincristine, and prednisone (H-CHOP) and reference rituximab plus CHOP (R-CHOP) in a total of 407 treatment-naïve, CD20-positive DLBCL patients aged 18-80 years. The primary efficacy endpoint was best overall response rate (ORR) within six cycles of treatment in the per-protocol set (PPS). Secondary endpoints included 1-year efficacy outcomes, safety, and immunogenicity profile. The results showed difference in ORRs [H-CHOP 94.1%; R-CHOP 92.8%] between two treatment groups was 1.4% (95% confidence interval [CI], - 3.59 to 6.32, p = 0.608) which falls within the pre-defined equivalence margin of ± 12%. The safety profile was comparable between the treatment groups, with a similar overall incidence of treatment-emergent adverse events (H-CHOP 99.5%, R-CHOP 99.0%, p = 1.000) and serious adverse events (H-CHOP 34.0%, R-CHOP 32.5%, p = 0.752). This study established bioequivalence in efficacy and safety between HLX01 and reference rituximab. The trial was registered at http://www.chinadrugtrials.org.cn on 26 August 2015 [#CTR20150583].
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.