# SHINE

Source: https://onco.cc/trials/shine/  
OnCo record `shine` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Adding a targeted tablet to first-line chemotherapy gave older people with mantle cell lymphoma about two and a half more years before the disease returned, but they did not live longer.

## Summary

SHINE randomised 523 people aged 65 or over with untreated mantle cell lymphoma to ibrutinib 560 mg daily until progression or unacceptable toxicity (261) or placebo (262), each with six cycles of bendamustine 90 mg per square metre and rituximab, followed by up to twelve further doses of rituximab maintenance every eight weeks in responders.

At a median follow-up of 84.7 months, median progression-free survival was 80.6 months with ibrutinib against 52.9 months with placebo (hazard ratio 0.75, 95 per cent confidence interval 0.59 to 0.96, p = 0.01). Complete response was 65.5 against 57.6 per cent (p = 0.06). Overall survival was similar in the two groups. Grade 3 or 4 adverse events during treatment occurred in 81.5 per cent against 77.3 per cent.

Twenty-eight months of extra progression-free time is a large number in a disease that is not curable with chemotherapy, and it did not translate into longer life, which is the finding that shaped what came next. The ECHO trial repeated the design with acalabrutinib, a more selective Bruton tyrosine kinase inhibitor chosen for lower toxicity, and ENRICH took the opposite route and removed the chemotherapy entirely.

## Fields

- Kind: Trial
- Status: mixed
- Last checked: 2026-10-01
- Also known as: Ibrutinib with bendamustine and rituximab in untreated mantle cell lymphoma; SHINE trial
- Tags: lymphoma-evidence
- Registry id: NCT01776840
- Phase: 3
- Setting: Aged 65 or over with untreated mantle cell lymphoma: ibrutinib added to six cycles of bendamustine and rituximab, with rituximab maintenance
- Sponsor: Janssen Research & Development, LLC
- Enrolled: 523
- Result: Median progression-free survival 80.6 against 52.9 months (hazard ratio 0.75, p = 0.01) with no overall survival difference.
- Outcomes: Progression-free survival (median): Ibrutinib with bendamustine and rituximab 80.6 months vs Placebo with bendamustine and rituximab 52.9 months, HR 0.75; Complete response rate: Ibrutinib with bendamustine and rituximab 65.5% vs Placebo with bendamustine and rituximab 57.6%
- Replication: Reproduced in direction and magnitude by ECHO with acalabrutinib; ENRICH tested a chemotherapy-free alternative in the same age group.

## Sources

- ClinicalTrials.gov NCT01776840: https://clinicaltrials.gov/study/NCT01776840
- New England Journal of Medicine 2022: https://doi.org/10.1056/NEJMoa2201817

## Connected records

- cancers: [Mantle cell lymphoma](https://onco.cc/cancers/mantle-cell-lymphoma/), [Non-Hodgkin lymphoma (all types)](https://onco.cc/cancers/non-hodgkin-lymphoma/)
- fronts: [Chemotherapy](https://onco.cc/fronts/chemotherapy/), [Targeted Therapy](https://onco.cc/fronts/targeted-therapy/)
- targets: [BTK (Bruton tyrosine kinase)](https://onco.cc/targets/btk/), [CCND1](https://onco.cc/targets/ccnd1/), [CD20](https://onco.cc/targets/cd20/)
- drugs: [Bendamustine](https://onco.cc/drugs/bendamustine/), [Ibrutinib](https://onco.cc/drugs/ibrutinib/), [Rituximab](https://onco.cc/drugs/rituximab/)
- companies: [Johnson & Johnson](https://onco.cc/companies/johnson-johnson/)
- pathways: [B-cell receptor / BTK signalling (to NF-κB)](https://onco.cc/pathways/bcr-signalling/)
- terms: [Maintenance and consolidation in lymphoma: where it works and where it does not](https://onco.cc/terms/lymphoma-tx-maintenance/), [Maintenance therapy](https://onco.cc/terms/maintenance-therapy/)
- trials: [A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL](https://onco.cc/trials/nct02972840/), [ENRICH](https://onco.cc/trials/enrich/), [TRIANGLE](https://onco.cc/trials/triangle/)
- people: [Martin Dreyling](https://onco.cc/people/martin-dreyling/), [Michael L. Wang](https://onco.cc/people/michael-wang/)
- bottlenecks: [Older and multimorbid patients are excluded and undertreated](https://onco.cc/bottlenecks/b-aging-comorbidity/), [Toxicity and quality of life are undervalued](https://onco.cc/bottlenecks/b-toxicity-qol/)
- key papers: [Acalabrutinib plus bendamustine-rituximab in untreated mantle cell lymphoma](https://onco.cc/key-papers/paper-echo-acalabrutinib-bendamustine-rituximab-mantle-cell-jco-2025/), [Ibrutinib and rituximab versus immunochemotherapy in patients with previously untreated mantle cell lymphoma (ENRICH): a randomised, open-label, phase 2/3 superiority trial](https://onco.cc/key-papers/paper-enrich-ibrutinib-rituximab-mantle-cell-lancet-2025/), [Ibrutinib plus bendamustine and rituximab in untreated mantle-cell lymphoma](https://onco.cc/key-papers/paper-shine-ibrutinib-bendamustine-rituximab-mantle-cell-nejm-2022/)
- roadmaps: [Lymphoma roadmap: from a jaw tumour in Uganda and the first human cancer virus to gene-expression subtypes, PET-adapted chemotherapy, CAR-T cells, bispecific antibodies and the genetics-directed trials now recruiting](https://onco.cc/roadmaps/lymphoma-roadmap/)

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