{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T07:45:52Z","timestamp":1789544752537,"version":"build-2803163510"},"reference-count":13,"publisher":"Ovid Technologies (Wolters Kluwer Health)","content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":[],"abstract":"\n Introduction:<\/jats:title>\n Bendamustine\u2013rituximab (BR) is the preferred regimen for the treatment of na\u00efve follicular lymphoma (FL). Recently, lenalidomide\u2013rituximab (LR), a chemotherapy-free protocol, has shown a good response rate in advanced FL. These regimens have never been compared in a randomized controlled trial for treatment-na\u00efve FL in Indian patients.<\/jats:p>\n <\/jats:sec>\n \n Materials and Methods:<\/jats:title>\n \n This Phase III open-label randomized controlled trial was conducted to compare the efficacy and safety of BR and LR. Treatment-na\u00efve patients older than 18 years of age, ECOG PS (Eastern Cooperative Oncology Group Performance Status) \u22642, who were diagnosed with FL (Stages II\u2013IV) were included in this study. Patients were randomized in a 1:1 ratio to receive six cycles of BR (bendamustine 90 mg\/m\n 2<\/jats:sup>\n Days 1\u20132 and rituximab 375 mg\/m\n 2<\/jats:sup>\n Day 1) every 4 weeks or LR (lenalidomide 20 mg Days 1\u201321 and rituximab 375 mg\/m\n 2<\/jats:sup>\n ) every 4 weeks. The primary end point was complete response (CR) and secondary end points were overall response rate (ORR) and toxicity.\n <\/jats:p>\n <\/jats:sec>\n \n Result:<\/jats:title>\n \n We enrolled 40 patients, 20 in each group with a median age of 53 years. The CR rate was 60% and 20% in BR and LR arms, respectively (\n P<\/jats:italic>\n = 0.01); however, the ORR was 88.8% and 87.3% in BR and LR arms, respectively (\n P<\/jats:italic>\n = 1.0). Anemia (35% versus 10%), skin rash (35% versus 30%), diarrhea (30% versus 10%), vomiting (20% versus 10%), nephrotoxicity (15% versus 0%), and transaminitis (10% versus 0%) were more in LR than in BR, and thrombocytopenia was higher in the BR than in the LR group but statistically not different. All grade toxicities were seen in 90% and 45% in LR and BR, respectively (\n P<\/jats:italic>\n = 0.05), but there was no significant difference in Grade 3 or 4 toxicity between the BR and the LR regimens (20% versus 25%).\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion:<\/jats:title>\n The ORR was similar in both the arms; however, the CR rate was significantly higher in the BR arm. BR was better tolerated than LR.<\/jats:p>\n (CTRI\/2016\/05\/006904).<\/jats:p>\n <\/jats:sec>","DOI":"10.4103\/ijc.ijc_633_20","type":"journal-article","created":{"date-parts":[[2024,1,8]],"date-time":"2024-01-08T23:00:08Z","timestamp":1704754808000},"update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":1,"title":["A Phase III open-label randomized study to compare the efficacy of lenalidomide\u2013rituximab with bendamustine\u2013 rituximab in treatment-na\u00efve follicular lymphoma"],"prefix":"10.4103","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8087-3212","authenticated-orcid":false,"given":"Sushant Kumar","family":"Paikaray","sequence":"first","affiliation":[{"name":"All India Institute of Medical Sciences, New Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6500-1061","authenticated-orcid":false,"given":"Ajay","family":"Gogia","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, All India Institute of Medical Sciences, New Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3945-2277","authenticated-orcid":false,"given":"Lalit","family":"Kumar","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, All India Institute of Medical Sciences, New Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0074-7804","authenticated-orcid":false,"given":"Atul","family":"Sharma","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, All India Institute of Medical Sciences, New Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3453-5340","authenticated-orcid":false,"given":"Ahit Agni","family":"Biswas","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, All India Institute of Medical Sciences, AIIMS, New Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1456-4029","authenticated-orcid":false,"given":"Sreeniwas","family":"Vishnubhatla","sequence":"additional","affiliation":[{"name":"Department of Biostatistics, AIIMS, New Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3872-0172","authenticated-orcid":false,"given":"Soumya","family":"Mallick","sequence":"additional","affiliation":[{"name":"Department of Pathology, All India Institute Of Medical Sciences, New Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","published-online":{"date-parts":[[2024,1,4]]},"reference":[{"key":"R1-20240828","doi-asserted-by":"crossref","first-page":"717","DOI":"10.1023\/A:1008265532487","article-title":"Epidemiology of the non-Hodgkin's lymphomas: Distributions of the major subtypes differ by geographic locations","volume":"9","author":"Anderson","year":"1998","journal-title":"Ann Oncol"},{"key":"R2-20240828","doi-asserted-by":"crossref","first-page":"1417","DOI":"10.1182\/blood-2004-08-3175","article-title":"CVP chemotherapy plus rituximab compared with CVP as first-line treatment for advanced follicular lymphoma","volume":"105","author":"Marcus","year":"2005","journal-title":"Blood"},{"key":"R3-20240828","doi-asserted-by":"crossref","first-page":"3725","DOI":"10.1182\/blood-2005-01-0016","article-title":"Frontline therapy with rituximab added to the combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) 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