AUGMENT

A Phase III study of lenalidomide plus rituximab versus placebo plus rituximab in relapsed or refractory indolent lymphoma

John P. Leonard, Marek Trneny, Koji Izutsu, Nathan H. Fowler, Xiaonan Hong, Jun Zhu, Huilai Zhang, Fritz Offner, Adriana Scheliga, Grzegorz S Nowakowski, Antonio Pinto, Francesca Re, Laura Maria Fogliatto, Phillip Scheinberg, Ian W. Flinn, Claudia Moreira, José Cabeçadas, David Liu, Stacey Kalambakas, Pierre Fustier & 2 others Chengqing Wu, John G. Gribben

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

PURPOSE Patients with indolent non-Hodgkin lymphoma typically respond well to first-line immunochemotherapy. At relapse, single-agent rituximab is commonly administered. Data suggest the immunomodulatory agent lenalidomide could increase the activity of rituximab. METHODS A phase III, multicenter, randomized trial of lenalidomide plus rituximab versus placebo plus rituximab was conducted in patients with relapsed and/or refractory follicular or marginal zone lymphoma. Patients received lenalidomide or placebo for 12 cycles plus rituximab once per week for 4 weeks in cycle 1 and day 1 of cycles 2 through 5. The primary end point was progression-free survival per independent radiology review. RESULTS A total of 358 patients were randomly assigned to lenalidomide plus rituximab (n = 178) or placebo plus rituximab (n = 180). Infections (63% v 49%), neutropenia (58% v 23%), and cutaneous reactions (32% v 12%) were more common with lenalidomide plus rituximab. Grade 3 or 4 neutropenia (50% v 13%) and leukopenia (7% v 2%) were higher with lenalidomide plus rituximab; no other grade 3 or 4 adverse event differed by 5% or more between groups. Progression-free survival was significantly improved for lenalidomide plus rituximab versus placebo plus rituximab, with a hazard ratio of 0.46 (95% CI, 0.34 to 0.62; P < .001) and median duration of 39.4 months (95% CI, 22.9 months to not reached) versus 14.1 months (95% CI, 11.4 to 16.7 months), respectively. CONCLUSION Lenalidomide improved efficacy of rituximab in patients with recurrent indolent lymphoma, with an acceptable safety profile.

Original languageEnglish (US)
Pages (from-to)1188-1199
Number of pages12
JournalJournal of Clinical Oncology
Volume37
Issue number14
DOIs
StatePublished - Jan 1 2019

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Lymphoma
Placebos
Neutropenia
Disease-Free Survival
lenalidomide
Rituximab
Leukopenia
Radiology
Non-Hodgkin's Lymphoma
Multicenter Studies
Safety
Recurrence
Skin
Infection

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

AUGMENT : A Phase III study of lenalidomide plus rituximab versus placebo plus rituximab in relapsed or refractory indolent lymphoma. / Leonard, John P.; Trneny, Marek; Izutsu, Koji; Fowler, Nathan H.; Hong, Xiaonan; Zhu, Jun; Zhang, Huilai; Offner, Fritz; Scheliga, Adriana; Nowakowski, Grzegorz S; Pinto, Antonio; Re, Francesca; Fogliatto, Laura Maria; Scheinberg, Phillip; Flinn, Ian W.; Moreira, Claudia; Cabeçadas, José; Liu, David; Kalambakas, Stacey; Fustier, Pierre; Wu, Chengqing; Gribben, John G.

In: Journal of Clinical Oncology, Vol. 37, No. 14, 01.01.2019, p. 1188-1199.

Research output: Contribution to journalArticle

Leonard, JP, Trneny, M, Izutsu, K, Fowler, NH, Hong, X, Zhu, J, Zhang, H, Offner, F, Scheliga, A, Nowakowski, GS, Pinto, A, Re, F, Fogliatto, LM, Scheinberg, P, Flinn, IW, Moreira, C, Cabeçadas, J, Liu, D, Kalambakas, S, Fustier, P, Wu, C & Gribben, JG 2019, 'AUGMENT: A Phase III study of lenalidomide plus rituximab versus placebo plus rituximab in relapsed or refractory indolent lymphoma', Journal of Clinical Oncology, vol. 37, no. 14, pp. 1188-1199. https://doi.org/10.1200/JCO.19.00010
Leonard, John P. ; Trneny, Marek ; Izutsu, Koji ; Fowler, Nathan H. ; Hong, Xiaonan ; Zhu, Jun ; Zhang, Huilai ; Offner, Fritz ; Scheliga, Adriana ; Nowakowski, Grzegorz S ; Pinto, Antonio ; Re, Francesca ; Fogliatto, Laura Maria ; Scheinberg, Phillip ; Flinn, Ian W. ; Moreira, Claudia ; Cabeçadas, José ; Liu, David ; Kalambakas, Stacey ; Fustier, Pierre ; Wu, Chengqing ; Gribben, John G. / AUGMENT : A Phase III study of lenalidomide plus rituximab versus placebo plus rituximab in relapsed or refractory indolent lymphoma. In: Journal of Clinical Oncology. 2019 ; Vol. 37, No. 14. pp. 1188-1199.
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abstract = "PURPOSE Patients with indolent non-Hodgkin lymphoma typically respond well to first-line immunochemotherapy. At relapse, single-agent rituximab is commonly administered. Data suggest the immunomodulatory agent lenalidomide could increase the activity of rituximab. METHODS A phase III, multicenter, randomized trial of lenalidomide plus rituximab versus placebo plus rituximab was conducted in patients with relapsed and/or refractory follicular or marginal zone lymphoma. Patients received lenalidomide or placebo for 12 cycles plus rituximab once per week for 4 weeks in cycle 1 and day 1 of cycles 2 through 5. The primary end point was progression-free survival per independent radiology review. RESULTS A total of 358 patients were randomly assigned to lenalidomide plus rituximab (n = 178) or placebo plus rituximab (n = 180). Infections (63{\%} v 49{\%}), neutropenia (58{\%} v 23{\%}), and cutaneous reactions (32{\%} v 12{\%}) were more common with lenalidomide plus rituximab. Grade 3 or 4 neutropenia (50{\%} v 13{\%}) and leukopenia (7{\%} v 2{\%}) were higher with lenalidomide plus rituximab; no other grade 3 or 4 adverse event differed by 5{\%} or more between groups. Progression-free survival was significantly improved for lenalidomide plus rituximab versus placebo plus rituximab, with a hazard ratio of 0.46 (95{\%} CI, 0.34 to 0.62; P < .001) and median duration of 39.4 months (95{\%} CI, 22.9 months to not reached) versus 14.1 months (95{\%} CI, 11.4 to 16.7 months), respectively. CONCLUSION Lenalidomide improved efficacy of rituximab in patients with recurrent indolent lymphoma, with an acceptable safety profile.",
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T2 - A Phase III study of lenalidomide plus rituximab versus placebo plus rituximab in relapsed or refractory indolent lymphoma

AU - Leonard, John P.

AU - Trneny, Marek

AU - Izutsu, Koji

AU - Fowler, Nathan H.

AU - Hong, Xiaonan

AU - Zhu, Jun

AU - Zhang, Huilai

AU - Offner, Fritz

AU - Scheliga, Adriana

AU - Nowakowski, Grzegorz S

AU - Pinto, Antonio

AU - Re, Francesca

AU - Fogliatto, Laura Maria

AU - Scheinberg, Phillip

AU - Flinn, Ian W.

AU - Moreira, Claudia

AU - Cabeçadas, José

AU - Liu, David

AU - Kalambakas, Stacey

AU - Fustier, Pierre

AU - Wu, Chengqing

AU - Gribben, John G.

PY - 2019/1/1

Y1 - 2019/1/1

N2 - PURPOSE Patients with indolent non-Hodgkin lymphoma typically respond well to first-line immunochemotherapy. At relapse, single-agent rituximab is commonly administered. Data suggest the immunomodulatory agent lenalidomide could increase the activity of rituximab. METHODS A phase III, multicenter, randomized trial of lenalidomide plus rituximab versus placebo plus rituximab was conducted in patients with relapsed and/or refractory follicular or marginal zone lymphoma. Patients received lenalidomide or placebo for 12 cycles plus rituximab once per week for 4 weeks in cycle 1 and day 1 of cycles 2 through 5. The primary end point was progression-free survival per independent radiology review. RESULTS A total of 358 patients were randomly assigned to lenalidomide plus rituximab (n = 178) or placebo plus rituximab (n = 180). Infections (63% v 49%), neutropenia (58% v 23%), and cutaneous reactions (32% v 12%) were more common with lenalidomide plus rituximab. Grade 3 or 4 neutropenia (50% v 13%) and leukopenia (7% v 2%) were higher with lenalidomide plus rituximab; no other grade 3 or 4 adverse event differed by 5% or more between groups. Progression-free survival was significantly improved for lenalidomide plus rituximab versus placebo plus rituximab, with a hazard ratio of 0.46 (95% CI, 0.34 to 0.62; P < .001) and median duration of 39.4 months (95% CI, 22.9 months to not reached) versus 14.1 months (95% CI, 11.4 to 16.7 months), respectively. CONCLUSION Lenalidomide improved efficacy of rituximab in patients with recurrent indolent lymphoma, with an acceptable safety profile.

AB - PURPOSE Patients with indolent non-Hodgkin lymphoma typically respond well to first-line immunochemotherapy. At relapse, single-agent rituximab is commonly administered. Data suggest the immunomodulatory agent lenalidomide could increase the activity of rituximab. METHODS A phase III, multicenter, randomized trial of lenalidomide plus rituximab versus placebo plus rituximab was conducted in patients with relapsed and/or refractory follicular or marginal zone lymphoma. Patients received lenalidomide or placebo for 12 cycles plus rituximab once per week for 4 weeks in cycle 1 and day 1 of cycles 2 through 5. The primary end point was progression-free survival per independent radiology review. RESULTS A total of 358 patients were randomly assigned to lenalidomide plus rituximab (n = 178) or placebo plus rituximab (n = 180). Infections (63% v 49%), neutropenia (58% v 23%), and cutaneous reactions (32% v 12%) were more common with lenalidomide plus rituximab. Grade 3 or 4 neutropenia (50% v 13%) and leukopenia (7% v 2%) were higher with lenalidomide plus rituximab; no other grade 3 or 4 adverse event differed by 5% or more between groups. Progression-free survival was significantly improved for lenalidomide plus rituximab versus placebo plus rituximab, with a hazard ratio of 0.46 (95% CI, 0.34 to 0.62; P < .001) and median duration of 39.4 months (95% CI, 22.9 months to not reached) versus 14.1 months (95% CI, 11.4 to 16.7 months), respectively. CONCLUSION Lenalidomide improved efficacy of rituximab in patients with recurrent indolent lymphoma, with an acceptable safety profile.

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