Evidence map›Paper›PMID 41212498›Full record

Trial reportInternational journal of hematology2026

Efficacy and safety of fixed-duration venetoclax plus obinutuzumab in untreated Japanese CLL and SLL: a phase 2 study.

Koji Izutsu, Mitsumasa Watanabe, Tomomi Toubai, Taku Tsukamoto, Dai Maruyama, Takahiro Kumode, Noriko Fukuhara, Natsumi Ogawa, Natsuko Satomi, Yasuko Nishimura and 3 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of hematology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05105841 (A Phase 2 Study of the Safety and Efficacy of Venetoclax in Combination With Obinutuzumab or Ibrutinib in Japanese Subjects With Previously Untreated 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.

NCT05105841 phase2completednot on this map

A Phase 2 Study of the Safety and Efficacy of Venetoclax in Combination With Obinutuzumab or Ibrutinib in Japanese Subjects With Previously Untreated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

TypeinterventionalSponsorAbbVieRan2021 to 2025Enrolled20ConditionsChronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL)ArmsVenetoclax, Ibrutinib, Obinutuzumab
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

13 authors.

Koji IzutsuDepartment of Hematology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. kizutsu@ncc.go.jp.ORCID http://orcid.org/0000-0001-9129-8057
Mitsumasa WatanabeHyogo Prefectural Amagasaki General Medical Center, Hyogo, Japan.
Tomomi ToubaiYamagata University Hospital, Yamagata, Japan.
Taku TsukamotoUniversity Hospital Kyoto Prefectural University of Medicine, Kyoto, Japan.
Dai MaruyamaCancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.
Takahiro KumodeKindai University Hospital, Osaka, Japan.
Noriko FukuharaTohoku University Hospital, Miyagi, Japan.
Natsumi OgawaAbbVie GK, Tokyo, Japan.
Natsuko SatomiAbbVie GK, Tokyo, Japan.
Yasuko NishimuraAbbVie GK, Tokyo, Japan.
Hideyuki HondaAbbVie GK, Tokyo, Japan.
Brenda ChylaAbbVie Inc., North Chicago, IL, USA.
Jun TakizawaNiigata University Faculty of Medicine, Niigata, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This phase 2 study (NCT05105841) evaluated the safety and efficacy of a fixed-duration 12-cycle regimen of venetoclax plus obinutuzumab in Japanese patients with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The primary efficacy endpoint was the complete remission (CR)/complete remission with incomplete marrow recovery (CRi) rate, assessed by an independent review committee (IRC) according to the 2008 International Workshop on CLL criteria. Ten patients (6 male, 4 female; 9 CLL, 1 SLL) with a median age of 69.5 years (range 52-76) received venetoclax for a median duration of 11.3 months (range 9.2-12.4). The IRC-assessed CR/CRi rate based on the best overall response was 90.0% (95% confidence interval 55.5%, 99.7%). All patients experienced at least one treatment-emergent adverse event (TEAE), and three patients (30.0%) experienced at least one serious TEAE. The most common TEAEs included infusion-related reactions (60.0%), decreased neutrophil count (50.0%), and nausea (40.0%). Nine patients (90.0%) experienced TEAEs related to venetoclax, while all ten patients (100.0%) had TEAEs related to obinutuzumab. One patient (10.0%) developed COVID-19 pneumonia, necessitating the discontinuation of venetoclax. These findings demonstrate the high efficacy and manageable safety profile of venetoclax plus obinutuzumab in this patient population.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBridged Bicyclo Compounds, HeterocyclicLeukemia, Lymphocytic, Chronic, B-CellSulfonamidesAgedEast Asian PeopleFemaleHumansJapanMaleMiddle AgedRemission InductionTreatment OutcomeAntibodies, Monoclonal, HumanizedBridged Bicyclo Compounds, HeterocyclicobinutuzumabSulfonamidesvenetoclaxChronic lymphocytic leukemiaFixed-duration therapyObinutuzumabSmall lymphocytic lymphomaVenetoclax

Identifiers

PMID41212498
PMCPMC12913321

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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.