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Ibrutinib Combined With Bendamustine and Rituximab in Newly Diagnosed Mantle Cell Lymphoma Patients Who Aged > 65 Years

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研究单位: [1]Peking University Third Hospital [2]Peking Union Medical College Hospital [3]The Second Affiliated Hospital of Dalian Medical University [4]Peking University First Hospital [5]Beijing Tongren Hospital [6]Beijing Hospital [7]Beijing Tsinghua Changgeng Hospital [8]China-Japan Friendship Hospital [9]307 Hospital of PLA [10]Chinese PLA General Hospital [11]First Affiliated Hospital of Harbin Medical University [12]Harbin Medical University [13]Baotou Cancer Hospital [14]Beijing Shijitan Hospital,Capital Medical University [15]Shanxi Province Cancer Hospital [16]Beijing Naval General Hospital [17]First Hospital of China Medical University [18]Jilin Provincial Tumor Hospital [19]Shengjing Hospital

关键词: MCL Ibrutinib aged > 65 years

研究目的:
This study is a prospective observational clinical trial. A total of 19 research centers were involved in this study. Each site plans to enroll 2-3 patients, and a total of 60 patients will be enrolled. Patients who met the diagnosis of mantle cell lymphoma by histological examination, ECOG (Eastern Oncology Collaborative Group) score 0-2, age >65 years, expected survival of more than 3 months, and at least one measurable lesion were included in this observational clinical trial. In this study, clinical data of patients treated with R-B regimen combined with ibrutinib will be collected, including routine clinical laboratory tests, examinations, and molecular biological data, for efficacy assessment and survival analysis. The main evaluation indicators are the total effective rate of 2 and 6 cycles of alternating R-CHOP/R-DHAP combined with ibrutinib in the treatment of newly treated muff cell lymphoma patients. The 3-year progression-free survival (PFS) and overall survival (OS) of the patients will be assessed, and adverse events to treatment will be collected to evaluate the safety of ibrutinib in combination with untreated mask cell lymphoma.

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