Lymphoma, Non-Hodgkin Clinical Trial
Official title:
A Study of the Zanubrutinib-containing Regimens in Patients With Newly Diagnosed Mantle Cell Lymphoma
This is a phase II, open-label, multicentre study of Zanubrutinib-containing regimens in patients with newly diagnosed mantle cell lymphoma.
This study is a prospective, multicenter, investigator-initiated clinical trial to evaluate the efficacy and safety of zanubrutinib-containing regimens in the treatment of newly diagnosed elderly or young patients with high risk MCL, aiming to find a more optimal treatment regimen for elderly or young patients with high risk MCL to improve the efficacy, survival time and quality of life of patients. In elderly patients arm：patients start with the induction therapy of zanubrutinib combined with obinutuzumab for 1 year and then entered the maintenance therapy of zanubrutinib orally until intolerable toxicity or disease progression In young patients with high risk arm：patiens <65 years，and meet one or more of the following risk factors: TP53 mutation, blastoid/pleomorphic type, high sMIPI score. patients start with 6 cycles of induction therapy with zanubrutinib combined with R-BAC regimen, and the patients who achieve CR/PR and meet the transplantation criteria will receive ASCT consolidationand, then received maintenance therapy with zanubrutinib. otherwise, Patients who is ineligible for transplantation，will take zanubrutinib orally until intolerable toxicity or disease progression. ;
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