TRIANGLE
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.
Overview
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.
- 88 vs 72 out of 100 alive at 3 years with Arm A+I: R-CHOP/R-DHAP + ibrutinib, transplant, ibrutinib maintenance compared with Arm A: R-CHOP/R-DHAP and autologous transplant; 16 more per 100.
- Roughly one extra person helped for every 6 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- Put another way, the treated group had about 48 percent lower chance of the event at any given time (hazard ratio 0.52).
- The p-value (0.0008 (one-sided)) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- 72 vs 86 out of 100 alive at 3 years with Arm A: R-CHOP/R-DHAP and autologous transplant compared with Arm I: R-CHOP/R-DHAP + ibrutinib, ibrutinib maintenance, no transplant; 14 fewer per 100.
- On this measure the first group did worse, not better.
- Put another way, the treated group had about 77 percent higher chance of the event at any given time (hazard ratio 1.77).
- The p-value (0.9979 (one-sided)) means the difference could plausibly be due to chance.
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- 50 vs 28 out of 100 reached this endpoint with Arm A+I compared with Arm I; 22 more per 100.
- On this measure the first group did worse, not better.
- Other groups: Arm A 21 of 100.
- This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
- 25 vs 19 out of 100 reached this endpoint with Arm A+I compared with Arm I; 6 more per 100.
- Roughly one extra person helped for every 17 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- Other groups: Arm A 13 of 100.
- This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
- These results apply to the people the trial enrolled: Previously untreated mantle cell lymphoma in patients up to 65 fit for transplant: alternating R-CHOP and R-DHAP induction followed by autologous transplant (arm A), the same with ibrutinib added to induction and as two-year maintenance (arm A+I), or ibrutinib-containing induction and maintenance without transplant (arm I). People in a different situation may not see the same effect.
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% |
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