Annals of hematology · 2022
Bendamustine plus rituximab in Japanese patients with relapsed or refractory diffuse large B-cell lymphoma.
Клиническое исследование III фазыСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Murayama Kayoko, Kiguchi Toru, Izutsu Koji, Kameoka Yoshihiro, Hidaka Michihiro, Kato Harumi, Rai Shinya, Kuroda Junya, Ishizawa Kenichi, Ichikawa Satoshi, Ando Kiyoshi, Ogura Michinori, Fukushima Koji, Terui Yasuhito
Аннотация
This single-arm phase 3 study was conducted to confirm the results of our phase 2 study of bendamustine (B)-rituximab (R) in patients with relapsed/refractory diffuse large B cell lymphoma (rrDLBCL). The primary endpoint was overall response rate (ORR). Autologous stem cell transplantation-ineligible rrDLBCL patients with ≤ 2 prior chemotherapy regimens received R 375 mg/m2 IV on day 1 and B 120 mg/m2/day IV on days 2 and 3 every 21 days up to 6 cycles. Thirty-eight patients with a median age of 74 years (range, 43-86) received BR. The ORR and complete response rates were 76.3% and 47.4%, respectively. With a median follow-up of 19.5 months including long-term follow-up, median progression-free survival was 11.9 months. Median OS was 29.2 months. Discontinuation of treatment due to Gr3-5 TEAE was observed among 13 of 38 patients (34.2%). One patient with cytomegalovirus enterocolitis died during follow-up. This BR regimen was confirmed to be effective and tolerable in studied patients. ClinicalTrials.gov Identifier: NCT03372837 registered on 14 December 2017, NCT04354402 registered on 21 April, 2020.