{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,27]],"date-time":"2026-09-27T14:58:04Z","timestamp":1790521084504,"version":"4.1.0"},"reference-count":15,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"31","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2015,11,1]]},"abstract":"<jats:sec><jats:title>Purpose<\/jats:title><jats:p>Lenalidomide and rituximab (LR) are active agents in follicular lymphoma (FL). Combination regimens have not been previously assessed in randomized studies.<\/jats:p><\/jats:sec><jats:sec><jats:title>Patients and Methods<\/jats:title><jats:p>The Cancer and Leukemia Group B (Alliance) 50401 trial is a randomized phase II trial studying rituximab (375 mg\/m<jats:sup>2<\/jats:sup>weekly for 4 weeks), lenalidomide (15 mg per day on days 1 to 21, followed by 7 days of rest, in cycle 1 and then 20 mg per day on days 1 to 21, followed by 7 days of rest, in cycles 2 to 12), or LR. The rituximab-alone arm was discontinued as a result of poor accrual. Eligibility included recurrent FL and prior rituximab with time to progression of \u2265 6 months from last dose. Aspirin or heparin was recommended for patients at high thrombosis risk.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Ninety-one patients (lenalidomide, n = 45; LR, n = 46) received treatment; median age was 63 years (range, 34 to 89 years), and 58% were intermediate or high risk according to the Follicular Lymphoma International Prognostic Index. In the lenalidomide and LR arms, grade 3 to 4 adverse events occurred in 58% and 53% of patients, with 9% and 11% of patients experiencing grade 4 toxicity, respectively; grade 3 to 4 adverse events included neutropenia (16% v 20%, respectively), fatigue (9% v 13%, respectively), and thrombosis (16% [n = 7] v 4% [n = 2], respectively; P = .157). Thirty-six percent of lenalidomide patients and 63% of LR patients completed 12 cycles. Lenalidomide alone was associated with more treatment failures, with 22% of patients discontinuing treatment as a result of adverse events. Dose-intensity exceeded 80% in both arms. Overall response rate was 53% (20% complete response) and 76% (39% complete response) for lenalidomide alone and LR, respectively (P = .029). At the median follow-up of 2.5 years, median time to progression was 1.1 year for lenalidomide alone and 2 years for LR (P = .0023).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>LR is more active than lenalidomide alone in recurrent FL with similar toxicity, warranting further study in B-cell non-Hodgkin lymphoma as a platform for addition of novel agents.<\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.2014.59.9258","type":"journal-article","created":{"date-parts":[[2015,8,25]],"date-time":"2015-08-25T02:03:48Z","timestamp":1440468228000},"page":"3635-3640","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":152,"title":["Randomized Trial of Lenalidomide Alone Versus Lenalidomide Plus Rituximab in Patients With Recurrent Follicular Lymphoma: CALGB 50401 (Alliance)"],"prefix":"10.1200","volume":"33","author":[{"given":"John P.","family":"Leonard","sequence":"first","affiliation":[{"name":"John P. Leonard, Meyer Cancer Center, Weill Cornell Medical College and New York Presbyterian Hospital, New York; Myron Czuczman, Roswell Park Cancer Institute, Buffalo, NY; Sin-Ho Jung, Jeffrey Johnson, and Brandelyn N. Pitcher, Alliance Statistics and Data Center, Duke University, Durham, NC; Nancy L. Bartlett, Washington University School of Medicine, St Louis, MO; Kristie A. Blum, Ohio State University Medical Center, Columbus, OH; Jeffrey K. Giguere, Greenville Community Clinical Oncology Program,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sin-Ho","family":"Jung","sequence":"additional","affiliation":[{"name":"John P. Leonard, Meyer Cancer Center, Weill Cornell Medical College and New York Presbyterian Hospital, New York; Myron Czuczman, Roswell Park Cancer Institute, Buffalo, NY; Sin-Ho Jung, Jeffrey Johnson, and Brandelyn N. Pitcher, Alliance Statistics and Data Center, Duke University, Durham, NC; Nancy L. Bartlett, Washington University School of Medicine, St Louis, MO; Kristie A. Blum, Ohio State University Medical Center, Columbus, OH; Jeffrey K. Giguere, Greenville Community Clinical Oncology Program,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey","family":"Johnson","sequence":"additional","affiliation":[{"name":"John P. Leonard, Meyer Cancer Center, Weill Cornell Medical College and New York Presbyterian Hospital, New York; Myron Czuczman, Roswell Park Cancer Institute, Buffalo, NY; Sin-Ho Jung, Jeffrey Johnson, and Brandelyn N. Pitcher, Alliance Statistics and Data Center, Duke University, Durham, NC; Nancy L. Bartlett, Washington University School of Medicine, St Louis, MO; Kristie A. Blum, Ohio State University Medical Center, Columbus, OH; Jeffrey K. Giguere, Greenville Community Clinical Oncology Program,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brandelyn N.","family":"Pitcher","sequence":"additional","affiliation":[{"name":"John P. Leonard, Meyer Cancer Center, Weill Cornell Medical College and New York Presbyterian Hospital, New York; Myron Czuczman, Roswell Park Cancer Institute, Buffalo, NY; Sin-Ho Jung, Jeffrey Johnson, and Brandelyn N. Pitcher, Alliance Statistics and Data Center, Duke University, Durham, NC; Nancy L. Bartlett, Washington University School of Medicine, St Louis, MO; Kristie A. Blum, Ohio State University Medical Center, Columbus, OH; Jeffrey K. Giguere, Greenville Community Clinical Oncology Program,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nancy L.","family":"Bartlett","sequence":"additional","affiliation":[{"name":"John P. Leonard, Meyer Cancer Center, Weill Cornell Medical College and New York Presbyterian Hospital, New York; Myron Czuczman, Roswell Park Cancer Institute, Buffalo, NY; Sin-Ho Jung, Jeffrey Johnson, and Brandelyn N. Pitcher, Alliance Statistics and Data Center, Duke University, Durham, NC; Nancy L. Bartlett, Washington University School of Medicine, St Louis, MO; Kristie A. Blum, Ohio State University Medical Center, Columbus, OH; Jeffrey K. Giguere, Greenville Community Clinical Oncology Program,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristie A.","family":"Blum","sequence":"additional","affiliation":[{"name":"John P. Leonard, Meyer Cancer Center, Weill Cornell Medical College and New York Presbyterian Hospital, New York; Myron Czuczman, Roswell Park Cancer Institute, Buffalo, NY; Sin-Ho Jung, Jeffrey Johnson, and Brandelyn N. Pitcher, Alliance Statistics and Data Center, Duke University, Durham, NC; Nancy L. Bartlett, Washington University School of Medicine, St Louis, MO; Kristie A. Blum, Ohio State University Medical Center, Columbus, OH; Jeffrey K. Giguere, Greenville Community Clinical Oncology Program,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Myron","family":"Czuczman","sequence":"additional","affiliation":[{"name":"John P. Leonard, Meyer Cancer Center, Weill Cornell Medical College and New York Presbyterian Hospital, New York; Myron Czuczman, Roswell Park Cancer Institute, Buffalo, NY; Sin-Ho Jung, Jeffrey Johnson, and Brandelyn N. Pitcher, Alliance Statistics and Data Center, Duke University, Durham, NC; Nancy L. Bartlett, Washington University School of Medicine, St Louis, MO; Kristie A. Blum, Ohio State University Medical Center, Columbus, OH; Jeffrey K. Giguere, Greenville Community Clinical Oncology Program,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey K.","family":"Giguere","sequence":"additional","affiliation":[{"name":"John P. Leonard, Meyer Cancer Center, Weill Cornell Medical College and New York Presbyterian Hospital, New York; Myron Czuczman, Roswell Park Cancer Institute, Buffalo, NY; Sin-Ho Jung, Jeffrey Johnson, and Brandelyn N. Pitcher, Alliance Statistics and Data Center, Duke University, Durham, NC; Nancy L. Bartlett, Washington University School of Medicine, St Louis, MO; Kristie A. Blum, Ohio State University Medical Center, Columbus, OH; Jeffrey K. Giguere, Greenville Community Clinical Oncology Program,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruce D.","family":"Cheson","sequence":"additional","affiliation":[{"name":"John P. Leonard, Meyer Cancer Center, Weill Cornell Medical College and New York Presbyterian Hospital, New York; Myron Czuczman, Roswell Park Cancer Institute, Buffalo, NY; Sin-Ho Jung, Jeffrey Johnson, and Brandelyn N. Pitcher, Alliance Statistics and Data Center, Duke University, Durham, NC; Nancy L. Bartlett, Washington University School of Medicine, St Louis, MO; Kristie A. Blum, Ohio State University Medical Center, Columbus, OH; Jeffrey K. 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