Evidence map›Paper›PMID 35796785›Full record

Trial reportCancer chemotherapy and pharmacology2022

A phase I/II study of 10-min dosing of bendamustine hydrochloride (rapid infusion formulation) in patients with previously untreated indolent B-cell non-Hodgkin lymphoma, mantle cell lymphoma, or relapsed/refractory diffuse large B-cell lymphoma in Japan.

Kenichi Ishizawa, Masahiro Yokoyama, Harumi Kato, Kazuhito Yamamoto, Masanori Makita, Kiyoshi Ando, Yasunori Ueda, Yoshimichi Tachikawa, Youko Suehiro, Mitsutoshi Kurosawa and 9 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer chemotherapy and pharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03900377 (A Multicenter, Open-label, Phase I/II Study to Investigate the Safety and Tolerability of SyB L-0501RI), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.1field-weighted citation impact, top 53% of its field
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.

NCT03900377 phase1 / phase2completednot on this map

A Multicenter, Open-label, Phase I/II Study to Investigate the Safety and Tolerability of SyB L-0501RI (Bendamustine Hydrochloride for Injection) Administered As an Intravenous (IV) Rapid Infusion Over 10 Minutes

TypeinterventionalSponsorSymBio PharmaceuticalsRan2019 to 2021Enrolled37ConditionsLymphoma, B-cell, DiffuseArmsSyB L-0501RI
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. Article
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

19 authors at 14 institutions in 1 country.

Kenichi IshizawaDepartment of Hematology, Yamagata University Hospital, Yamagata, Japan. kishizaw@med.id.yamagata-u.ac.jp.ORCID 0000-0003-4911-8889
Masahiro YokoyamaDepartment of Hematology Oncology, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.
Harumi KatoDepartment of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan.
Kazuhito YamamotoDepartment of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan.
Masanori MakitaDepartment of Hematology, National Hospital Organization Okayama Medical Center, Okayama, Japan.
Kiyoshi AndoDepartment of Hematology and Oncology, Tokai University Hospital, Isehara, Japan.
Yasunori UedaDepartment of Hematology/Oncology, Ohara HealthCare Foundation Kurashiki Central Hospital, Kurashiki, Japan.
Yoshimichi TachikawaDepartment of Hematology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
Youko SuehiroDepartment of Hematology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
Mitsutoshi KurosawaDepartment of Hematology, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan.
Yoshihiro KameokaDepartment of Hematology, Akita University Hospital, Akita, Japan.
Hirokazu NagaiDepartment of Hematology, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
Nobuhiko UoshimaDepartment of Hematology, Japanese Red Cross Kyoto Daini Hospital, Kyoto, Japan.
Takayuki IshikawaDepartment of Hematology, Kobe City Medical Center General Hospital, Kobe, Japan.
Michihiro HidakaDepartment of Hematology, National Hospital Organization Kumamoto Medical Center, Kumamoto, Japan.
Yoshikiyo ItoDepartment of Hematology, Imamura General Hospital, Kagoshima, Japan.
Atae UtsunomiyaDepartment of Hematology, Imamura General Hospital, Kagoshima, Japan.
Koji FukushimaSymBio Pharmaceuticals Limited, Tokyo, Japan.
Michinori OguraDepartment of Hematology and Oncology, Kasugai Municipal Hospital, Kasugai, Japan.
Aichi Cancer Center · JPImamura Hospital · JPNational Hospital Organization · JPNational Hospital Organization Kyushu Cancer Center · JPAkita University Hospital · JPJapanese Red Cross Society Kyoto Daini Hospital · JPKasugai Municipal Hospital · JPKobe City Medical Center General Hospital · JPKumamoto Medical Center · JPKurashiki Central Hospital · JPNational Hospital Organization Hokkaido Medical Center · JPThe Cancer Institute Hospital · JPTokai University Hospital · JPYamagata University Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis phase I/II clinical study was conducted to examine the safety, tolerability, pharmacokinetics, and efficacy of 10-min dosing of bendamustine in patients with previously untreated indolent B-cell non-Hodgkin lymphoma (iNHL) or mantle cell lymphoma (MCL) (Group 1) and patients with relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL) (Group 2).

methodsRituximab 375 mg/m

resultsAmong 37 enrolled patients, safety was assessed in 36. In Group 1 (n = 30), 27 patients (90%) had follicular lymphoma. Adverse events (AEs) were observed in all 30 patients in Group 1. Dose-limiting toxicities were observed in two of six patients in Group 2. Common AEs included lymphocyte count decreased (86.7%, 100%). In Group 1, overall response and complete response rates were 93.1% (95% confidence interval [CI] 77.2-99.2%) and 75.9% (95% CI 56.5-89.7%), respectively. The C

conclusionsThis study showed that bendamustine is safe, well-tolerated and effective for patients with previously untreated iNHL, MCL or rrDLBCL. Pharmacokinetic data were equivalent to those obtained outside of Japan. REGISTRATION NUMBERS: Registration NCT03900377; registered April 3, 2019.

Indexed as

Bendamustine HydrochlorideLymphoma, Large B-Cell, DiffuseLymphoma, Mantle-CellLymphoma, Non-HodgkinNeoplasm Recurrence, LocalAdultHumansJapanBendamustine HydrochlorideBendamustineNon-Hodgkin lymphomaPhase I/IIRapid infusionSafetyTolerability

Identifiers

PMID35796785
PMCPMC9300521
OpenAlexW4284880971

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.