{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["101(5)"],"submitter":["Murayama K"],"pubmed_abstract":["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/m<sup>2</sup> IV on day 1 and B 120 mg/m<sup>2</sup>/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."],"journal":["Annals of hematology"],"pagination":["979-989"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC8993776"],"repository":["biostudies-literature"],"pubmed_title":["Bendamustine plus rituximab in Japanese patients with relapsed or refractory diffuse large B-cell lymphoma."],"pmcid":["PMC8993776"],"pubmed_authors":["Fukushima K","Kuroda J","Ando K","Ogura M","Terui Y","Izutsu K","Hidaka M","Kato H","Ishizawa K","Kiguchi T","Murayama K","Ichikawa S","Rai S","Kameoka Y"],"additional_accession":[]},"is_claimable":false,"name":"Bendamustine plus rituximab in Japanese patients with relapsed or refractory diffuse large B-cell lymphoma.","description":"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/m<sup>2</sup> IV on day 1 and B 120 mg/m<sup>2</sup>/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.","dates":{"release":"2022-01-01T00:00:00Z","publication":"2022 May","modification":"2024-11-11T21:45:47.23Z","creation":"2024-11-11T21:45:47.23Z"},"accession":"S-EPMC8993776","cross_references":{"pubmed":["35244756"],"doi":["10.1007/s00277-022-04801-2"]}}