Addition of autologous stem-cell transplantation to an ibrutinib-containing first-line treatment in patients aged 18-65 years with mantle cell lymphoma (TRIANGLE): 4·5-year follow-up of a three-arm, randomised, open-label, phase 3 superiority trial of the European MCL Network.

What was studied

TRIANGLE was a phase 3 trial in adults aged 18-65 years. They had untreated mantle cell lymphoma. It ran at 165 centres in 13 European countries and Israel. 870 people were assigned by chance to 3 groups. One got standard treatment with a stem-cell transplant. One got ibrutinib plus the transplant. One got ibrutinib with no transplant. The main measure was failure-free survival.

What they found

Median follow-up was 55 months. Ibrutinib plus transplant was no better than ibrutinib alone. It stayed better than standard treatment for failure-free survival. Standard treatment was no better than ibrutinib alone. Overall survival was better in both ibrutinib groups than with standard treatment. Blood disorders and infections of grade 3-5 were the most common side events. They were more frequent with ibrutinib plus transplant. Infections were the most common fatal side events.

What it means for patients

The team says both ibrutinib groups did better on both kinds of survival. They say the transplant gave no extra benefit but more toxicity. The plan is ibrutinib plus chemotherapy, then 2 years of ibrutinib. They say it deserves to be weighed as a new standard for younger adults.

Why it is not certain yet

The trial was open-label. People and doctors knew the treatment. It included only adults aged 18-65 years. Rituximab maintenance was allowed in all groups. Janssen funded the trial.

Source

Addition of autologous stem-cell transplantation to an ibrutinib-containing first-line treatment in patients aged 18-65 years with mantle cell lymphoma (TRIANGLE): 4·5-year follow-up of a three-arm, randomised, open-label, phase 3 superiority trial of the European MCL Network.

We restate facts from the source record in our own words. The original wording belongs to its publisher.