Trial reportJournal for immunotherapy of cancer2024
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.
Trial report in Journal for immunotherapy of cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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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.
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Who cites it
5 citing papers in PubMed.
- Heterogeneity in primary gastrointestinal DLBCL: from clinical management to molecular mechanisms and treatment strategies.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026Review
- Primary thyroid lymphoma with Hashimoto's thyroiditis: A case report and literature review.Oncology letters · 2026Article
- Asia's emergence in cancer immunotherapy: challenges and opportunities.Journal for immunotherapy of cancer · 2025Article
- Cost-Effectiveness of First-Line Zuberitamab-CHOP versus Rituximab-CHOP Regimens in Untreated CD20+ Diffuse Large B-Cell Lymphoma in China.Risk management and healthcare policy · 2025Article
- Efficacy and safety of zuberitamab in the treatment of primary membranous nephropathy: an observational study.Frontiers in immunology · 2025Observational
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Authors and funding
44 authors.
Funding
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Abstract
backgroundIn patients with untreated CD20-positive diffuse large B-cell lymphoma (DLBCL), a phase 3 trial was carried out to evaluate the efficacy and safety of zuberitamab plus CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone; Hi-CHOP) versus rituximab plus CHOP (R-CHOP) treatment regimens.
methodsIn a 2:1 ratio, eligible patients were assigned randomly to receive treatment of six cycles of either 375 mg/m
resultsOf the 487 randomized patients, 423 patients including 287 in the Hi-CHOP and 136 in the R-CHOP groups completed the C6D50 assessment. For the full analysis set (FAS) and per-protocol set (PPS), BIRC-assessed ORR at C6D50 for the Hi-CHOP and R-CHOP groups were 83.5% versus 81.4% and 95.3% versus 93.7%, respectively. The non-inferiority was confirmed as the lower limit of the two-sided 95% CI for the intergroup differences of -5.2% and -3.3%; both were >-10% in the FAS and PPS. The BIRC-assessed CR rate of Hi-CHOP was significantly higher in PPS (85.7% vs 77.3%, p=0.038), but comparable in FAS (75.2% vs 67.9%, p=0.092). After a median follow-up of 29.6 months, patients in the Hi-CHOP group had a slight advantage with regard to the DOR (HR 0.74, p=0.173), PFS (HR 0.67, p=0.057), EFS (HR 0.90, p=0.517) and OS (HR 0.60, p=0.059). Patients with the germinal-center B cell-like subtype who received Hi-CHOP exhibited statistically significant improvements in ORR (p=0.034) and CR rate (p=0.038) at C6D50, EFS (p=0.046) and OS (p=0.014). Treatment-emergent adverse event occurrence rates were comparable across groups (all p>0.05). Infusion-related responses occurred more often in the Hi-CHOP group (32.1% vs 19.9%, p=0.006), all of grade 1-3 severity.
conclusionsZuberitamab (375 mg/m TRIAL REGISTRATION NUMBER: Chinese Clinical Trial Registry, ChiCTR2000040602, retrospectively registered.
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