Evidence map›Paper›PMID 34599413›Full record

Trial reportInternational journal of clinical oncology2022

Phase 2 study of axicabtagene ciloleucel in Japanese patients with relapsed or refractory large B-cell lymphoma.

Koji Kato, Shinichi Makita, Hideki Goto, Junya Kanda, Nobuharu Fujii, Kazuyuki Shimada, Koichi Akashi, Koji Izutsu, Takanori Teshima, Natsuko Fukuda and 8 more

Abstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of clinical oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 4 pooled it
–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

17 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Second Primary Malignancies after CAR T-Cell Therapy: A Systematic Review and Meta-analysis of 5,517 Lymphoma and Myeloma Patients.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024
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  16. Prolonged haematologic toxicity in CAR-T-cell therapy: A review.Journal of cellular and molecular medicine · 2023
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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

18 authors.

Koji KatoDepartment of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Sciences, 3-1-1, Maidashi, Fukuoka Higashi-ku, Fukuoka, 812-8582, Japan. kato.koji.429@m.kyushu-u.ac.jp.ORCID http://orcid.org/0000-0002-5815-4585
Shinichi MakitaDepartment of Hematology, National Cancer Center Hospital, 5-1-1, Tsukiji , Chuo, Tokyo, 104-0045, Japan.
Hideki GotoDepartment of Hematology, Hokkaido University Faculty of Medicine, Kita 15, Nishi 7, Kita-ku, Sapporo, 060-8638, Japan.
Junya KandaDepartment of Hematology and Oncology, Graduate School of Medicine, Kyoto University, Yoshida-Konoe-cho, Sakyo-ku, Kyoto, 606-8501, Japan.
Nobuharu FujiiDepartment of Hematology and Oncology, Okayama University Hospital, 2-5-1 Shikata-cho, Kitaku, Okayama, 700-8558, Japan.
Kazuyuki ShimadaDepartment of Hematology and Oncology, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan.
Koichi AkashiDepartment of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Sciences, 3-1-1, Maidashi, Fukuoka Higashi-ku, Fukuoka, 812-8582, Japan.
Koji IzutsuDepartment of Hematology, National Cancer Center Hospital, 5-1-1, Tsukiji , Chuo, Tokyo, 104-0045, Japan.
Takanori TeshimaDepartment of Hematology, Hokkaido University Faculty of Medicine, Kita 15, Nishi 7, Kita-ku, Sapporo, 060-8638, Japan.
Natsuko FukudaDaiichi Sankyo Co., Ltd, 1-2-58, Hiromachi, Shinagawa, Tokyo, 140-8710, Japan.
Tokuhito SumitaniDaiichi Sankyo Co., Ltd, 1-2-58, Hiromachi, Shinagawa, Tokyo, 140-8710, Japan.
Hiroyuki SumiDaiichi Sankyo Co., Ltd, 1-2-58, Hiromachi, Shinagawa, Tokyo, 140-8710, Japan.
Shinji ShimizuDaiichi Sankyo Co., Ltd, 1-2-58, Hiromachi, Shinagawa, Tokyo, 140-8710, Japan.
Yasuyuki KakuraiDaiichi Sankyo Co., Ltd, 1-2-58, Hiromachi, Shinagawa, Tokyo, 140-8710, Japan.
Kenji YoshikawaDaiichi Sankyo Co., Ltd, 1-2-58, Hiromachi, Shinagawa, Tokyo, 140-8710, Japan.
Kensei TobinaiGeriatric Health Services Facility Rehabilitation Care Funabashi, 4-8-30 Honcho, Funabashi, Chiba, 273-005, Japan.
Noriko UsuiDepartment of Clinical Oncology and Hematology, The Jikei University Daisan Hospital, 4-11-1 Izumihoncho, Komae, Tokyo, 201-8601, Japan.
Kiyohiko HatakeDepartment of Lymphoma/Hematology Center, Mita Hospital, International University of Health and Welfare, 1-4-3 Mita, Minato, Tokyo, 108-8329, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAxicabtagene ciloleucel (axi-cel) is an autologous chimeric antigen receptor T-cell based anti-CD19 therapy. The ZUMA-1 study, multicenter, single-arm, registrational Phase 1/2 study of axi-cel demonstrated high objective response rate in patients with relapsed/refractory large B-cell lymphoma. Here, we present the results of the bridging study to evaluate the efficacy and safety of axi-cel in Japanese patients (JapicCTI-183914).

methodsThis study was the phase 2, multicenter, open-label, single-arm trial. Following leukapheresis, axi-cel manufacturing and lymphodepleting chemotherapy, patients received a single infusion of axi-cel (2.0 × 10

resultsAmong 17 enrolled patients, 16 received axi-cel infusion. In the 15 efficacy evaluable patients, objective response rate was 86.7% (95% confidence interval: 59.5-98.3%); complete response/partial response were observed in 4 (26.7%)/9 (60.0%) patients, respectively. No dose-limiting toxicities were observed. Grade ≥ 3 treatment-emergent adverse events occurred in 16 (100%) patients-most commonly neutropenia (81.3%), lymphopenia (81.3%) and thrombocytopenia (62.5%). Cytokine release syndrome occurred in 13 (81.3%) patients (12 cases of grade 1 or 2 and 1 case of grade 4). No neurologic events occurred. Two patients died due to disease progression, but no treatment-related death was observed by the data-cutoff date (October 23, 2019).

conclusionThe efficacy and safety of axi-cel was confirmed in Japanese patients with relapsed/refractory large B-cell lymphoma who have otherwise limited treatment options.

trial registrationJapicCTI-183914.

Indexed as

Biological ProductsLymphoma, Large B-Cell, DiffuseAntigens, CD19HumansJapanAntigens, CD19axicabtagene ciloleucelBiological ProductsAxicabtagene ciloleucelCD19-specific chimeric antigen receptorJapanKTE-C19Non-Hodgkin lymphoma

Identifiers

PMID34599413
PMCPMC8732921

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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.