Evidence map›Paper›PMID 39167348›Full record

Trial reportInternational journal of hematology2024

Venetoclax treatment for chronic lymphocytic leukemia/small lymphocytic leukemia in Japan: post-marketing surveillance.

Tomoki Ito, Tomohiko Kamimura, Toru Kiguchi, Koji Kato, Risa Takenaka, Mariko Kobayashi, Ayumi Ito, Mizu Sakai, Koji Izutsu

Erratum issued Registry-linked trialAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of hematology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04198415 (Post-Marketing All-Patient Drug Use Results Study for Venetoclax in Japanese Patients With Relapsed and Refractory Chronic Lymphocytic Leukemia), which is not on this 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.

NCT04198415 completednot on this map

Post-Marketing All-Patient Drug Use Results Study for Venetoclax in Japanese Patients With Relapsed and Refractory Chronic Lymphocytic Leukemia (Including Small Lymphocytic Leukemia)

TypeobservationalSponsorAbbVieRan2020 to 2022Enrolled4ConditionsCancer, Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Leukemia (SLL)
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

5 · Who and what money

Authors and funding

9 authors.

Tomoki ItoDepartment of Hematology, Kansai Medical University Hospital, 2-3-1 Shinmachi, Hirakata City, Osaka, Japan. itot@hirakata.kmu.ac.jp.ORCID http://orcid.org/0000-0001-5419-9156
Tomohiko KamimuraDepartment of Hematology, Harasanshin Hospital, Fukuoka, Japan.
Toru KiguchiDepartment of Diabetes, Endocrinology and Hematology, Dokkyo Medical University Saitama Medical Center, Saitama, Japan.
Koji KatoDepartment of Hematology, Oncology and Cardiovascular Medicine, Kyushu University Hospital, Fukuoka, Japan.
Risa TakenakaAbbVie GK, Tokyo, Japan.
Mariko KobayashiAbbVie GK, Tokyo, Japan.
Ayumi ItoAbbVie GK, Tokyo, Japan.
Mizu SakaiAbbVie GK, Tokyo, Japan.
Koji IzutsuDepartment of Hematology, National Cancer Center Hospital, Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Venetoclax was approved for relapsed/refractory chronic lymphocytic leukemia (R/R CLL) and small lymphocytic leukemia (SLL) in Japan in September 2019; however, clinical data in Japanese patients are limited. This all-case post-marketing surveillance assessed efficacy and safety in Japanese patients with R/R CLL/SLL who started venetoclax treatment between November 2019 and August 2020. Overall, the safety and efficacy analysis sets included 129 and 114 patients, respectively. The overall response rate (ORR) was 57.0%; ORRs were higher in patients with versus without concomitant rituximab (65.4% vs. 54.7%), and in patients with 1 versus ≥ 2 prior lines of therapies (72.5% vs. 44.4%). Adverse events (AEs) were reported in 66.7% of patients (86/129); the most common AEs were neutrophil count decreased (22.5%), white blood cell count decreased (7.8%), and tumor lysis syndrome (TLS; 6.2%). AEs of special interest (TLS, myelosuppression, and infection) were manageable in clinical practice in Japan. Venetoclax is efficacious and safe for R/R CLL/SLL patients in the real-world setting in Japan. ClinicalTrials.gov ID: NCT04198415.

Indexed as

Bridged Bicyclo Compounds, HeterocyclicLeukemia, Lymphocytic, Chronic, B-CellProduct Surveillance, PostmarketingSulfonamidesAdultAgedAged, 80 and overAntineoplastic AgentsFemaleHumansJapanMaleMiddle AgedTreatment OutcomeTumor Lysis SyndromeAntineoplastic AgentsBridged Bicyclo Compounds, HeterocyclicSulfonamidesvenetoclaxChronic lymphocytic leukemiaJapanPost-marketing surveillanceVenetoclax

Identifiers

PMID39167348
PMCPMC11513738

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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.