The randomized phase III TRIANGLE trial of the European MCL network is the largest study ever conducted in MCL.
The trial evaluated the addition of ibrutinib to a standard ASCT containing treatment (arm A+I) in comparison to standard treatment (arm A) and to an ibrutinib containing treatment without ASCT (arm I). 870 patients from 13 countries with untreated, stage II-IV MCL were enrolled.The study included regular MRD analyses with collection of baseline and multiple follow-up samples, generating a large tissue and plasma collection for translational studies. Moreover, FFPE tissues from most patients are available for additional histopatological testing.
Therefore, TRIANGLE is a unique opportunity for multilayer characterization of a large patient cohort treated with the new standard of care. MULTIPLY will generate and validate an integrative model of various clinico-biological baseline and dynamic follow-up parameters. Based on functional analysis we will also identify potential new therapeutic targets.
MULTIPLY is structured into 3 major interconnected workpackages (WP):
a) Identification of clinical predictors, characterization of relapses and salvage treatment (Clinical project);
b) Identification of lymph node derived predictors (Lymph node WP);
c) Evaluation of biological predictors based on PB, BM and cfDNA (Liquid tissue WP).
All information will be integrated to generate a multilayer model of prediction incorporating all available clinical and biological markers.