Evidence map›Paper›PMID 41402979›Full record

ArticleJapanese journal of clinical oncology2026

Protocol digest of a randomized phase III study of pola-R-CHP/high-dose methotrexate/IT vs. pola-R-CHP/IT for newly diagnosed diffuse large B-cell lymphoma with high risk of central nervous system relapse: JCOG2201 (PREMIER).

Yusuke Sano, Kana Miyazaki, Motoko Yamaguchi, Senzo Taguchi, Ryunosuke Machida, Kota Kawabata, Haruhiko Fukuda, Kazuyuki Shimada, Hirokazu Nagai, Wataru Munakata and 2 more

Abstract readClinical Trial Protocol
In one paragraph

Article in Japanese journal of clinical oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Review
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

12 authors.

Yusuke SanoJapan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.ORCID 0000-0001-7753-8712
Kana MiyazakiDepartment of Hematology and Oncology, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu, Mie 514-8507, Japan.ORCID 0000-0001-6547-3181
Motoko YamaguchiDepartment of Hematological Malignancies, Mie University Graduate School of Medicine, 2-174 Edobashi, Mie 514-8507, Japan.ORCID 0000-0002-7094-6489
Senzo TaguchiDepartment of Radiation Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo 135-8550, Japan.ORCID 0000-0002-3932-8084
Ryunosuke MachidaJapan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.
Kota KawabataJapan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.
Haruhiko FukudaJapan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.
Kazuyuki ShimadaDepartment of Hematology and Oncology, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8550, Japan.ORCID 0000-0002-1075-9219
Hirokazu NagaiDepartment of Hematology, National Hospital Organization Nagoya Medical Center, 4-1-1 Sannomaru, Naka-ku, Nagoya, Aichi 460-0001, Japan.
Wataru MunakataDepartment of Hematology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.ORCID 0000-0002-4679-0656
Dai MaruyamaDepartment of Hematology Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo 135-8550, Japan.ORCID 0000-0003-0654-6920
Japan Clinical Oncology Group Lymphoma Study Group

Funding

Japan Agency for Medical Research and Development JP24ck0106976National Cancer Center Research and Development Fund 2023-J-03
6 · The paper itself

Abstract

Diffuse large B-cell lymphoma (DLBCL) is the most common subtype of non-Hodgkin lymphoma. Central nervous system (CNS) relapse is an uncommon yet lethal event in patients with DLBCL. Polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisolone (pola-R-CHP) is a standard of care for patients with untreated DLBCL. In patients with DLBCL at high risk of CNS relapse, the intrathecal (IT) administration of methotrexate and cytarabine is widely adopted for CNS prophylaxis; however, the optimal treatment is unclear. The aim of this multicenter randomized phase III trial is to confirm the superiority of high-dose methotrexate administered during early cycles of pola-R-CHP in addition to IT chemotherapy for patients with untreated DLBCL at high risk of CNS relapse. A total of 390 patients from 52 institutions will be enrolled across a 4-year period. The primary endpoint is progression-free survival. This trial was registered in the Japan Registry of Clinical Trials as jRCTs031230505 [https://jrct.mhlw.go.jp/latest-detail/jRCTs031230505].

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCentral Nervous System NeoplasmsLymphoma, Large B-Cell, DiffuseAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedClinical Trials, Phase III as TopicCyclophosphamideCytarabineDoxorubicinFemaleHumansImmunoconjugatesInjections, SpinalMaleAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCyclophosphamideCytarabineDoxorubicinImmunoconjugatesMethotrexatepolatuzumab vedotinPrednisoloneRituximabcentral nervous systemdiffuse large B-cell lymphomaintrathecal injectionsmethotrexate

Identifiers

PMID41402979
PMCPMC13016924

What OpenQuestion holds

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Registered trials

None linked

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.