Evidence map›Paper›PMID 39997358›Full record

Trial reportJapanese journal of clinical oncology2025

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, Kenichi Ishizawa, Ryunosuke Machida, Ryo Sadachi, Keita Sasaki, Haryoon Kim, Keisuke Kataoka, Wataru Munakata, Noriko Fukuhara, Hirokazu Nagai and 1 more

Abstract readMulticenter StudyRandomized Controlled TrialClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Japanese journal of clinical oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Tsutomu KobayashiDepartment of Hematology, Japanese Red Cross Kyoto Daiichi Hospital, 15-749 Honmachi, Higashiyama-ku, Kyoto 605-0981, Japan.ORCID 0000-0002-5600-5762
Kenichi IshizawaDepartment of Nursing, Faculty of Health Sciences, Tohoku Fukushi University, 1-8-1 Kunimi Aoba-ku Sendai-shi Miyagi, 981-8522, Japan.
Ryunosuke MachidaJapan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.
Ryo SadachiJapan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.
Keita SasakiJapan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.ORCID 0009-0005-5100-3863
Haryoon KimDivision of Hematology, Department of Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan.
Keisuke KataokaDivision of Hematology, Department of Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan.
Wataru MunakataDepartment of Hematology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.ORCID 0000-0002-4679-0656
Noriko FukuharaDepartment of Hematology, Tohoku University Graduate School, 2-1-1 Katahira, Aoba-ku, Sendai, Miyagi 980-8577, Japan.
Hirokazu NagaiDepartment of Hematology and Oncology, National Hospital Organization Nagoya Medical Center, 1-1 Sannomaru 4-chome, Naka-ku, Nagoya 460-0001, Japan.
Lymphoma Study Group of the Japan Clinical Oncology Group

Funding

Japan Agency for Medical Research and Development JP22ck0106750National Cancer Center Research and Development Fund 2020-J-3National Cancer Center Research and Development Fund 2023-J-03
6 · The paper itself

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.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBendamustine HydrochlorideLymphoma, FollicularAgedFemaleHumansInduction ChemotherapyMaintenance ChemotherapyMaleMiddle AgedTumor BurdenAntibodies, Monoclonal, HumanizedBendamustine Hydrochlorideobinutuzumabbendamustinecomplete metabolic responsefollicular lymphomamaintenance therapyobinutuzumab

Identifiers

PMID39997358
PMCPMC12138771

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.