TRIANGLE
In younger transplant-eligible mantle-cell lymphoma, does adding ibrutinib improve outcomes, and can ASCT be omitted within an ibrutinib strategy?
One underlying study; aliases and follow-up reports consolidated. Primary discipline: Medical.
870 patients aged ≤65 years with previously untreated stage II–IV mantle-cell lymphoma suitable for ASCT.
Younger transplant-eligible patients; not directly applicable to older or transplant-ineligible patients.
870 across three arms randomised/evaluable as reported.
Ibrutinib 560 mg daily integrated with alternating R-CHOP and cytarabine/platinum-based immunochemotherapy; ASCT in the transplant arm. A separate ibrutinib strategy omitted ASCT.
Standard immunochemotherapy followed by ASCT.
Endpoints and results
Primary FFS; OS, toxicity and role of ASCT key outcomes.
- 3-year FFS 88% with ibrutinib+ASCT strategy vs 72% with standard ASCT strategy; HR 0.52 (one-sided 98.3% CI 0–0.86; p=0.0008).
- Standard ASCT strategy was not shown superior to the ibrutinib strategy without ASCT; the primary report did not settle the direct value of ASCT within an ibrutinib regimen.
- During maintenance/follow-up, grade 3–5 haematological AEs 50%, 28%, 21% across ibrutinib+ASCT, ibrutinib without ASCT, and standard ASCT arms; infections 25%, 19%, 13%.
Absolute Effect and outcome visualisation
3-year FFS
% failure-free at 3 years · 3 years. Bars show source-reported fixed-time percentages.
Interpretation: For primary comparison, 16-point 3-year FFS difference corresponds to approximate landmark NNT 7. Do not use this to claim ASCT can be omitted; that is a separate comparison.
Toxicity, discontinuation and quality of life
Trial-specific harms: Haematological toxicity and infection; ibrutinib class risks include bleeding, atrial fibrillation, hypertension and drug interactions.
Treatment burden/discontinuation: Complex intensive immunochemotherapy, possible transplant and prolonged ibrutinib maintenance.
Quality of life: No numeric QoL comparison asserted without full PRO report.
Subgroups, maturity and limitations
Subgroups: Do not infer universal ASCT omission from non-significance; direct arm comparison and follow-up matter.
Maturity: Phase III primary report 2024; longer follow-up informs ASCT question.
Limitations: Three-arm trial answers distinct inferential questions. Adding ibrutinib to ASCT-based treatment was superior; ASCT omission is not universally established.
TRIANGLE supports adding ibrutinib to intensive first-line therapy in younger transplant-eligible MCL, but does not prove every patient can omit ASCT.
Use current regional guidelines, patient fitness, biomarkers, competing risks, alternatives and regulatory status before clinical application. Clinical freshness review and browser-rendered QA remain pending.
Primary sources and registry
Registry: NCT02858258
The Absolute Effect · Updated 26 October 2026 · Never derive NNT from median survival.