TRIANGLE showed that adding the pill ibrutinib to the chemotherapy given to younger people with mantle cell lymphoma keeps the disease away for longer, and that when ibrutinib is used the stem cell transplant that used to be compulsory no longer adds a clear benefit while adding side effects.
TRIANGLE was a three-arm open-label phase 3 trial of the European Mantle Cell Lymphoma Network in 870 patients aged 18 to 65 with untreated stage II to IV mantle cell lymphoma, randomised to standard R-CHOP/R-DHAP induction and autologous transplant (arm A), the same with ibrutinib during R-CHOP cycles and for two years of maintenance (arm A+I), or ibrutinib-containing induction and maintenance without transplant (arm I). The primary endpoint was failure-free survival.
After 31 months of median follow-up, three-year failure-free survival was 88 percent in arm A+I against 72 percent in arm A (hazard ratio 0.52), while superiority of arm A over arm I was not shown (72 against 86 percent); the comparison of A+I against I continues. Grade 3 to 5 haematological adverse events and infections during maintenance were far more frequent after transplant plus ibrutinib than with ibrutinib alone. The corpus's mantle cell lymphoma page cites TRIANGLE for the conclusion that transplant no longer adds benefit when ibrutinib is used.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
870 enrolled.
95% CI 84 to 92; median follow-up 31 months · 95% CI 67 to 79
Source95% CI 82 to 91
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Failure-free survival at 3 years, arm A+I against arm Aprimary | Arm A+I: R-CHOP/R-DHAP + ibrutinib, transplant, ibrutinib maintenance | 292 | 88% | 0.52 | 0.0008 (one-sided) | link |
| Arm A: R-CHOP/R-DHAP and autologous transplant | 288 | 72% | ||||
| Failure-free survival at 3 years, arm A against arm I (superiority of transplant not shown)primary | Arm A: R-CHOP/R-DHAP and autologous transplant | 288 | 72% | 1.77 | 0.9979 (one-sided) | link |
| Arm I: R-CHOP/R-DHAP + ibrutinib, ibrutinib maintenance, no transplant | 290 | 86% | ||||
| Grade 3 to 5 haematological adverse events during maintenance or follow-up | Arm A+I | 231 | 50% | - | - | link |
| Arm I | 269 | 28% | ||||
| Arm A | 238 | 21% | ||||
| Grade 3 to 5 infections during maintenance or follow-up | Arm A+I | 231 | 25% | - | - | link |
| Arm I | 269 | 19% | ||||
| Arm A | 238 | 13% |
Ibrutinib during induction and as maintenance should be part of first-line treatment for younger patients with mantle cell lymphoma; whether transplant adds anything to an ibrutinib-containing regimen is still being followed.
One of the few maintenance strategies in lymphoma that improved overall survival rather than only progression-free survival, and the reason three years of rituximab became standard after autologous transplantation in mantle cell lymphoma.
Shares Prednisone, Vincristine, Rituximab, 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 and the tag soc-trials.
Shares Prednisone, Vincristine, Rituximab, Doxorubicin and the tag soc-trials.
Shares Prednisone, Vincristine, Rituximab, 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 and the tag soc-trials.
Shares Autologous stem cell transplant (high-dose therapy), Vincristine, Doxorubicin, Cyclophosphamide and the tag soc-trials.
Shares Prednisone, Vincristine, Doxorubicin, Cyclophosphamide and the tag soc-trials.
Shares Cytarabine, Autologous stem cell transplant (high-dose therapy), Rituximab, 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 and the tag soc-trials.
Shares Cytarabine, Autologous stem cell transplant (high-dose therapy), Rituximab, 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 and the tag soc-trials.
Shares Prednisone, Vincristine, Doxorubicin, Cyclophosphamide and the tag soc-trials.