MATRix–RICE therapy and autologous haematopoietic stem-cell transplantation in diffuse large B-cell lymphoma with secondary CNS involvement (MARIETTA): an international, single-arm, phase 2 trial
作者:Andrés J.M. Ferreri, Jeanette K. Doorduijn, Alessandro Re, Maria Giuseppina Cabras, Jeffery Smith, Fiorella Ilariucci, Mario Luppi, Teresa Calimeri, Chiara Cattaneo, Jahanzaib Khwaja, Barbara Botto, Claudia Cellini, Luca Nassi, Kim Linton, Pam McKay, Jacopo Olivieri, Caterina Patti, Francesca Re, Alessandro Fanni, Vikram Singh, Jacoline E. C. Bromberg, Kelly Cozens, Elisabetta Gastaldi, Massimo Bernardi, Nicola Cascavilla, Andrew Davies, Christopher P. Fox, Maurizio Frezzato, Wendy Osborne, Anna Marina Liberati, Urban Novak, Renato Zambello, Emanuele Zucca, Kate Cwynarski · 发表于:The Lancet Haematology · 年份:2021 · DOI:10.1016/s2352-3026(20)30366-5 · 被引用次数:108 · 研究领域:CNS Lymphoma Diagnosis and Treatment、Lymphoma Diagnosis and Treatment、CAR-T cell therapy research
Background Secondary CNS lymphoma is a rare but potentially lethal event in patients with diffuse large B-cell lymphoma. We aimed to assess the activity and safety of an intensive, CNS-directed chemoimmunotherapy consolidated by autologous haematopoietic stem-cell transplantation (HSCT) in patients with secondary CNS lymphoma. Methods This international, single-arm, phase 2 trial was done in 24 hospitals in Italy, the UK, the Netherlands, and Switzerland. Adults (aged 18–70 years) with histologically diagnosed diffuse large B-cell lymphoma and CNS involvement at the time of primary diagnosis or at relapse and Eastern Cooperative Oncology Group Performance Status of 3 or less were enrolled and received three courses of MATRix (rituximab 375 mg/m 2 , intravenous infusion, day 0; methotrexate 3·5 g/m 2 , the first 0·5 g/m 2 in 15 min followed by 3 g/m 2 in a 3 h intravenous infusion, day 1; cytarabine 2 g/m 2 every 12 h, in 1 h intravenous infusions, days 2 and 3; thiotepa 30 mg/m 2 , 30 min intravenous infusion, day 4) followed by three courses of RICE (rituximab 375 mg/m 2 , day 1; etoposide 100 mg/m 2 per day in 500–1000 mL over a 60 min intravenous infusion, days 1, 2, and 3; ifosfamide 5 g/m 2 in 1000 mL in a 24 h intravenous infusion with mesna support, day 2; carboplatin area under the curve of 5 in 500 mL in a 1 h intravenous infusion, day 2) and carmustine–thiotepa and autologous HSCT (carmustine 400 mg/m 2 in 500 mL glucose 5% solution in a 1–2 h infusion, day −6; thio...