followed by Obinutuzumab maintenance for 3 years then Obinutuzumab on-demand for MRD positive patients. The LYMA-101 primary objective was the MRD negativity rate after 4 cycles of O-DHAP. MRD in the BM was assessed by IGH clonospecific or bcl1-JH PCR, and quantification with a sensitivity of at least 10 -4 was reach by dd-PCR following Euro-MRD lymphoma group recommendations. We hypothesized that O-DHAP would be considered as an effective induction chemotherapy regimen if MRD negativity was ≥ 70%. We calculated that a minimum of 83 patients should be included (α risk of 0.05 and β of 0.20 one-sided test). Results:We enrolled 86 patients between Nov 2016 and May 2018.One patient withdrew consent before starting treatment. Sixty-three patients (73.3%) were male and median age was 55.5 years ). MIPI and MIPI-b risk scores were low in 47 (54.7%) and 9 (10.5%) cases, intermediate in 24 (27.9%) and 38 (44.2%) cases and high in 14 (16.3%) and 21 (24.4%) cases. Fifteen patients (17.4%) presented with a blastoid variant. At the time of analysis, median FU was 14 months (3.8-24.4). Twelve patients out of 85 were not evaluable for MRD, essentially due to purely nodal disease and no detectableMCL clone in PB or BM. Among the 73 MRD-informative patients, 62 reached MRD negativity in the BM (84.9%) while 6 were MRD positive after O-DHAP. The remaining 5 patients were not evaluated because 4 stopped treatment during induction due to AEs and one progressed then died. 72 patients underwent ASCT and 68 started Obinutuzumab maintenance. Twelve patients stopped treatment before ASCT (including disease progression in 2 cases and AE in 7 cases), 3 before maintenance (2 because of AE, one died during ASCT), and 9 during maintenance (including disease progression in one case, death in another, AE in 4 cases or other malignancies in 2 cases). In the whole population (n=85), 3 patients progressed, three died. At one year, PFS is 93.4% (IC95%, 84.7-97.2) and OS is 96% (IC95%, 88.1-98.7). Conclusion: The Lyma-101 trial successfully achieved its primary endpoint (84.9% of MRD BM negativity after induction) and demonstrates the high efficacy of O-DHAP as induction chemotherapy regimen before ASCT with an unprecedented high level of MRD negativity, which predict better PFS and OS. Longer FU is needed to evaluate patient outcome after O-DHAP/ASCT/Obinutuzumab on-demand maintenance. However, both PFS and OS are highly encouraging at one year. Introduction: Zanubrutinib is a selective and irreversible BTK inhibitor that has demonstrated potent inhibition of BTK in prior studies, with minimal, off-target inhibition of other kinases. We present updated safety and efficacy results from a phase 2 study of zanubrutinib in patients with R/R MCL. Methods: In this single-arm, multicenter phase 2 study (ClinicalTrials. gov NCT03206970), oral zanubrutinib (160 mg BID) was given to R/R MCL patients until disease progression (PD) or unacceptable toxicity. Primary endpoint was overall response rate (ORR) assessed by an independent review committee (IRC) acco...

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