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Erutini, obinutuzumab, and ventclax showed synergy in preclinical models of set cell lymphoma (MCL).
OASIS (NCT02558816) is a one-arm, multi-center Phase I/II prospective trial designed to determine maximum tolerance (MTD) for patients with a combined fixed dose of venotclax erutinib and obinutuzumab to treat relapsed MCLs.
patients with relapsed/primary treatment MCL were treated with the largest to-1otclax static drops in the extended queue.
secondary goal is security and effectiveness.
14 October 2015 - 29 May 2018, 48 patients were recruited.
no dose-limiting toxicity (DLT) has been reported, using 400 mg/day as venotclax's MTD for extending the queue.
18 (75%) patients (75%) and 8 (53%) first-time patients experienced 3/4 adverse events (AE).
at the end of the 6th course, the full response rate assessed by the electron emission fault scan was 67% in the recurrence group and 86.6% in the initial treatment group.
at the end of the 3rd course of treatment, 71.5% of relapsed patients (10/14) and 100% of primary MRDs assessed the patient's micro-residual lesions (MRD) transfusion.
follow-up period (mFU) was 17 months (10 to 35 months) in patients with relapse.
progress-free survival rate (PFS) and overall survival rate (OS) were 69.5% (95% CI, 52.9 to 91.4%) and 68.6% (95% CI, 49.5 to 95.1%) respectively.
mFU was 14 months (5 to 19 months) and 1 year PFS was 93.3% (95% CI, 81.5 to 100%).
summary, for patients with relapsed/primary TREATMENT MCL, the combined programmes of Obinutuzimab, Erutini and ventclax are well resistant, providing a high response/mitigation rate, including at the molecular level.
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