Trial reportLancet (London, England)2025
Ibrutinib and rituximab versus immunochemotherapy in patients with previously untreated mantle cell lymphoma (ENRICH): a randomised, open-label, phase 2/3 superiority trial.
Trial report in Lancet (London, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 2 of them syntheses that pooled it.
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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
10 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Cellular therapy in mantle cell lymphoma: recommendations from the EBMT practice harmonisation and guidelines committee.Bone marrow transplantation · 2026Guideline
- Comparative Efficacy of BTK Inhibitors in Treatment-Naïve and Relapsed/Refractory Mantle Cell Lymphoma: A Systematic Review and Meta-Analysis.Journal of cellular and molecular medicine · 2026Pooled it
- Molecular biomarkers as key determinants of outcome in mantle cell lymphoma: results from the FIL V-RBAC trial.Blood advances · 2026Trial
- Older patients with lymphoma: navigating a landscape of clinical controversies and barriers to innovation.Haematologica · 2026Review
- BTK Inhibitors for the Treatment of Mantle Cell Lymphoma-Current Status and Perspectives.Cancers · 2026Review
- First-Line Bruton's Tyrosine Kinase Inhibitor-Based Regimens for Mantle Cell Lymphoma.Current oncology (Toronto, Ont.) · 2026Review
- [Chinese expert consensus on the diagnosis and treatment of elderly patients with mantle cell lymphoma (2026)].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2026Article
- Evolving therapeutic strategies in mantle cell lymphoma: advancements and future directions.Leukemia · 2026Review
- Mantle cell lymphoma outcomes following sequential first-line bendamustine-rituximab and second-line Bruton's tyrosine kinase inhibitor therapy.Blood cancer journal · 2026Article
- Brute force: the effects of ibrutinib on brexu-cel.Blood advances · 2026Article
Corrections and comments
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Authors and funding
31 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIbrutinib, a Bruton tyrosine kinase inhibitor, prolongs progression-free survival when added to immunochemotherapy as first line treatment. The ENRICH trial compared the chemotherapy-free combination of ibrutinib and the anti-CD20 antibody rituximab (ibrutinib-rituximab) with standard immunochemotherapy (R-CHOP [rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisolone] or bendamustine-rituximab) in patients 60 years and older with untreated mantle-cell lymphoma.
methodsThis randomised, open-label, phase 2/3 superiority trial was performed at 66 sites in the UK, Sweden, Norway, Finland, and Denmark. Patients 60 years and older with untreated mantle-cell lymphoma (Ann-Arbor stage II-IV disease, an Eastern Cooperative Oncology Group performance-status score of 0-2) were randomly assigned to receive either rituximab plus immunochemotherapy or ibrutinib-rituximab in a 1:1 ratio, stratified by investigator choice of immunochemotherapy. Patients randomly allocated to the ibrutinib-rituximab (intervention) group received 560 mg oral ibrutinib daily in combination with six to eight cycles of 375 mg/m
findingsBetween Feb 15, 2016, and June 30, 2021, 397 patients were randomly allocated to immunochemotherapy (control) or ibrutinib-rituximab (intervention). Of the 397, 107 (27%) were pre-allocated to the immunochemotherapy choice of R-CHOP and 290 (73%) were pre-allocated to rituximab-bendamustine. In total, 198 were allocated to the control group (53 to R-CHOP and 145 to bendamustine-rituximab) and 199 were allocated to intervention. The median age was 74 years (IQR 70-77) for the intervention group and 74 years (70-78) in the control group. 296 patients (75%) were male and 101 patients (25%) were female; ethnicity data were not collected. At a median follow-up of 47·9 months, the median progression-free survival of ibrutinib-rituximab was superior to immunochemotherapy, with an adjusted hazard ratio (HR) of 0·69 (95% CI 0·52-0·90); p=0·0034. For those with pre-randomisation choice R-CHOP, the HR was 0·37 (0·22-0·62), and with bendamustine-rituximab, the HR was 0·91 (0·66-1·25). Across induction and maintenance, 67% of patients assigned to ibrutinib-rituximab and 70% of patients receiving immunotherapy reported grade 3 or above adverse events.
interpretationTo our knowledge, this is the first randomised trial in untreated mantle-cell lymphoma to demonstrate significant improvement in progression-free survival for ibrutinib-rituximab compared to immunochemotherapy. This study suggests that ibrutinib-rituximab should be considered a new standard of care option for first-line treatment of older patients with mantle-cell lymphoma.
fundingCancer Research UK (C7627/A17938) and Johnson and Johnson Pharmaceuticals.
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