Obinutuzumab maintenance versus observation for patients with newly diagnosed high tumor burden follicular lymphoma who achieved complete metabolic response after obinutuzumab plus bendamustine induction therapy: a multicenter, randomized, phase III study (JCOG2008, MAIN study)

Affiliations

¹ Department of Hematology, Japanese Red Cross Kyoto Daiichi Hospital, 15-749 Honmachi, Higashiyama-ku, Kyoto 605-0981, Japan.
² Department of Nursing, Faculty of Health Sciences, Tohoku Fukushi University, 1-8-1 Kunimi Aoba-ku Sendai-shi Miyagi, 981-8522, Japan.
³ Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.
⁴ Division of Hematology, Department of Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan.
⁵ Division of Molecular Oncology, National Cancer Center Research Institute, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.
⁶ Department of Hematology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.
⁷ Department of Hematology, Tohoku University Graduate School, 2-1-1 Katahira, Aoba-ku, Sendai, Miyagi 980-8577, Japan.
⁸ Department of Hematology and Oncology, National Hospital Organization Nagoya Medical Center, 1-1 Sannomaru 4-chome, Naka-ku, Nagoya 460-0001, Japan.

PMID: 39997358
PMCID: PMC12138771
DOI: 10.1093/jjco/hyaf038

Clinical Trial

Obinutuzumab maintenance versus observation for patients with newly diagnosed high tumor burden follicular lymphoma who achieved complete metabolic response after obinutuzumab plus bendamustine induction therapy: a multicenter, randomized, phase III study (JCOG2008, MAIN study)

Tsutomu Kobayashi et al. Jpn J Clin Oncol. 2025.

. 2025 Jun 5;55(6):666-671.

doi: 10.1093/jjco/hyaf038.

Affiliations

¹ Department of Hematology, Japanese Red Cross Kyoto Daiichi Hospital, 15-749 Honmachi, Higashiyama-ku, Kyoto 605-0981, Japan.
² Department of Nursing, Faculty of Health Sciences, Tohoku Fukushi University, 1-8-1 Kunimi Aoba-ku Sendai-shi Miyagi, 981-8522, Japan.
³ Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.
⁴ Division of Hematology, Department of Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan.
⁵ Division of Molecular Oncology, National Cancer Center Research Institute, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.
⁶ Department of Hematology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.
⁷ Department of Hematology, Tohoku University Graduate School, 2-1-1 Katahira, Aoba-ku, Sendai, Miyagi 980-8577, Japan.
⁸ Department of Hematology and Oncology, National Hospital Organization Nagoya Medical Center, 1-1 Sannomaru 4-chome, Naka-ku, Nagoya 460-0001, Japan.

PMID: 39997358
PMCID: PMC12138771
DOI: 10.1093/jjco/hyaf038

Abstract

Maintenance therapy with monoclonal anti-CD20 antibody is the standard approach in patients with follicular lymphoma who initially treated and achieved response to immunochemotherapy. Maintenance therapy reduces the risk of lymphoma progression, but the risk of late or delayed fatal treatment-emergent adverse events is a clinically important issue. The aim of this randomized phase III study is to confirm the non-inferiority of observation compared to obinutuzumab maintenance therapy in patients with untreated high tumor burden follicular lymphoma who achieved complete metabolic response after obinutuzumab plus bendamustine induction therapy (JCOG2008, MAIN study). The first registration is performed before obinutuzumab plus bendamustine administration. Those who achieved complete metabolic response at the end of induction are included in the second registration and randomized to an obinutuzumab maintenance arm or observation only. This study has been registered in the Japan Registry for Clinical Trials as jRCT1031210379.

Keywords: bendamustine; complete metabolic response; follicular lymphoma; maintenance therapy; obinutuzumab.

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Conflict of interest statement

T.K. reports honoraria from Bristol-Myers Squibb, Chugai Pharmaceutical, Nippon Shinyaku, Sanofi, Symbio, Nippon Kayaku, AstraZeneca, AbbVie, MSD, and Janssen Pharmaceutical. K.I. reports honoraria from Chugai Pharmaceutical, Ono Pharmaceutical, Janssen Pharmaceutical, AbbVie, Symbio; participation on advisory board of Ono Pharmaceutical, Kyowa Kirin, Symbio. K.K. reports grants, consulting fees, and honoraria from Meiji Seika Pharma; grants and honoraria from Asahi Kasei Pharma, Eisai, Kyowa Kirin, Daiichi Sankyo, Takeda Pharmaceutical, Sumitomo Dainippon Pharma, Chugai Pharmaceutical, Nippon Shinyaku, Nippon Kayaku, and Bristol-Myers Squibb; grants and consulting fees from Otsuka Pharmaceutical; grants from Shionogi, Teijin Pharma, Japan Blood Products Organization, Mochida Pharamaceutical, JCR Pharmaceutical, Chordia Therapeutics, Genmab and Regeneron; honoraria from Ono Pharmaceutical, Astellas Pharma, Novartis, AstraZeneca, Janssen Pharmaceutical, MSD, Symbio, Pfizer, Alexion Pharmaceuticals, AbbVie, Sanofi, Sysmex, Mundipharma, Incyte Corporation, Kyorin Pharmaceutical, PharmaEssentia Japan, Gilead Sciences, Kowa, Amgen, and Asahi Kasei Pharma; as well as reports a patent for Genetic alterations as a biomarker in T-cell lymphomas licensed to Kyoto University and PD-L1 abnormalities as a predictive biomarker for immune checkpoint blockade therapy licensed to Kyoto University. W.M. reports grants and honoraria from Chugai Pharmaceutical, Janssen Pharmaceutical, Ono Pharmaceutical, Genmab, and Nippon Shinyaku; grants from Kyowa Kirin; honoraria from Takeda Pharmaceutical, Eisai, Novartis, Bristol-Myers Squibb, AstraZeneca, Symbio, Mundipharma, Gilead Sciences, Nippon Kayaku, MSD, AbbVie, and Amgen. N.F. reports grants and honoraria from Abbvie, Chugai pharmaceutical, Chordia Therapeutics, Genmab, Incyte Corporation, Kyowa Kirin, Loxo Oncology and Takeda Pharmaceutical; honoraria from AstraZeneca, Bristol-Myers Squibb, CSL Behring, Eisai, Eli Lilly, Janssen, Pharmaceutical, Nippon Shinyaku, Novartis, Ono Pharmaceutical, Sanofi, and Symbio. H.N. reports grants and honoraria from AbbVie, AstraZeneca, Beigene, Genmab, Janssen Pharmaceutical, Eli Lilly, Takeda Pharmaceutical, Kyowa Kirin, MSD, Chugai Pharmaceutical, and Ono Pharmaceutical; grants from Incyte Corporation, Mitsubishi Tanabe, Daiichi Sankyo, Celgene, Zenyaku Kogyo, Solasia, Regeneron, and Haihe; honoraria from Eisai, Novartis, Sumitomo Dainippon Pharma, Meiji Seika Pharma, Mundipharma, GSK, Bristol-Myers Squibb, Nippon Kayaku, and Nippon Shinyaku. Others have no conflicts of interest to declare.

Figures

**Figure 1**
**Study schema of JCOG2008.** ECOG PS, European Clinical Oncology Group Performance Status; FLIPI2, follicular lymphoma international prognostic index 2.

See this image and copyright information in PMC

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Obinutuzumab maintenance versus observation for patients with newly diagnosed high tumor burden follicular lymphoma who achieved complete metabolic response after obinutuzumab plus bendamustine induction therapy: a multicenter, randomized, phase III study (JCOG2008, MAIN study)

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Obinutuzumab maintenance versus observation for patients with newly diagnosed high tumor burden follicular lymphoma who achieved complete metabolic response after obinutuzumab plus bendamustine induction therapy: a multicenter, randomized, phase III study (JCOG2008, MAIN study)

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