Evidence map›Paper›PMID 41175112›Full record

Observational studyFuture oncology (London, England)2025

Fixed-duration ibrutinib-venetoclax for first-line treatment of patients with chronic lymphocytic leukemia: the REALITY-WW prospective real-world study cohort.

Talha Munir, Danielle Leão, Boo Messahel, Sowmya Srikanthan, Ping Xu, Mohamed Fouad, Claire Kavanagh, Christoph Tapprich, Oliver Miles, Adriana Scheliga and 1 more

Abstract readObservational Study
In one paragraph

Observational study in Future oncology (London, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the 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.

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

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

11 authors.

Talha MunirDepartment of Hematology, St James's University Hospital, Leeds, UK.
Danielle LeãoA Beneficência Portuguesa de São Paulo, São Paulo, Brazil.
Boo MessahelJohnson & Johnson R&D, Bridgewater, NJ, USA.
Sowmya SrikanthanJohnson & Johnson R&D, Bridgewater, NJ, USA.
Ping XuJohnson & Johnson R&D, Titusville, NJ, USA.
Mohamed FouadJohnson & Johnson Middle East FZ-LLC, Dubai, UAE.
Claire KavanaghJohnson & Johnson, Dublin, Ireland.
Christoph TapprichJohnson & Johnson, Neuss, Germany.
Oliver MilesMusgrove Park Hospital, Taunton, UK.
Adriana ScheligaInstituto Oncoclinicas, Rio de Janeiro, Brazil.
Paolo GhiaUniversità Vita-Salute San Raffaele, Milan, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The fixed-duration combination of ibrutinib and venetoclax has shown significant benefits in the first-line treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) through clinical studies with follow-up extending up to 5.5 years. However, there remains an important gap in real-world data regarding efficacy and tolerability outcomes of this regimen outside of clinical trial settings. The REALITY-Worldwide study has been initiated as a prospective observational study aimed at understanding the usage, factors for therapy decision, and clinical response of first-line fixed-duration ibrutinib-venetoclax in routine clinical practice. The primary endpoint is physician-assessed overall response rate according to 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria. Secondary endpoints and outcomes of interest include duration of response, progression-free survival, overall survival, time to next treatment, tumor lysis syndrome risk, adverse events, patient-reported outcomes, factors associated with physician decision to initiate fixed-duration ibrutinib-venetoclax in clinical practice, medical resource utilization, and patient-reported outcomes. The study aims to enroll approximately 200 patients across Europe, the Middle East, and Latin America. A pooled analysis will include subsets of data collected from REALITY-WW and the ongoing multicenter REALITY-2 study in Germany.

Indexed as

AdenineAntineoplastic Combined Chemotherapy ProtocolsBridged Bicyclo Compounds, HeterocyclicLeukemia, Lymphocytic, Chronic, B-CellSulfonamidesAgedFemaleHumansMaleMiddle AgedObservational Studies as TopicPiperidinesProspective StudiesTreatment OutcomeAdenineBridged Bicyclo Compounds, HeterocyclicibrutinibPiperidinesSulfonamidesvenetoclaxCLL/SLLibrutinib-venetoclaxmechanism of actionprospectiveREALITY-WWreal-world

Identifiers

PMID41175112
PMCPMC12688257

What OpenQuestion holds

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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.