Evidence map›Paper›PMID 39082668›Full record

Trial reportBlood2024

Venetoclax-obinutuzumab for previously untreated chronic lymphocytic leukemia: 6-year results of the randomized phase 3 CLL14 study.

Othman Al-Sawaf, Sandra Robrecht, Can Zhang, Stefano Olivieri, Yi Meng Chang, Anna Maria Fink, Eugen Tausch, Christof Schneider, Matthias Ritgen, Karl-Anton Kreuzer and 18 more

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Blood, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02242942 (A Prospective, Open-Label, Multicenter Randomized Phase III Trial to Compare The Efficacy and Safety of A Combined Regimen of Obinutuzumab and Venetoclax Versus Obinutuzumab and Chlorambucil in Previously Untreated Patients With CLL and Coexisting Medical Conditions), which is not on this map. Cited by 92 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
92citing papers in PubMed, 2 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.

NCT02242942 phase3completednot on this map

A Prospective, Open-Label, Multicenter Randomized Phase III Trial to Compare The Efficacy and Safety of A Combined Regimen of Obinutuzumab and Venetoclax Versus Obinutuzumab and Chlorambucil in Previously Untreated Patients With CLL and Coexisting Medical Conditions

TypeinterventionalSponsorHoffmann-La RocheRan2014 to 2025Enrolled445ConditionsLymphocytic Leukemia, ChronicArmsChlorambucil, Venetoclax, Obinutuzumab
3 · Its place in the literature

Who cites it

92 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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  11. Refined Continuous Risk Index for Accurately Predicting Outcomes of Patients With Chronic Lymphocytic Leukemia After Limited-Duration Therapy.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2026
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32 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

28 authors.

Othman Al-SawafDepartment I of Internal Medicine, Faculty of Medicine and University Hospital of Cologne, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, German Chronic Lymphocytic Leukemia Study Group, University of Cologne, Cologne, Germany.ORCID 0000-0001-9895-0570
Sandra RobrechtDepartment I of Internal Medicine, Faculty of Medicine and University Hospital of Cologne, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, German Chronic Lymphocytic Leukemia Study Group, University of Cologne, Cologne, Germany.
Can ZhangDepartment I of Internal Medicine, Faculty of Medicine and University Hospital of Cologne, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, German Chronic Lymphocytic Leukemia Study Group, University of Cologne, Cologne, Germany.
Stefano OlivieriF. Hoffmann-La Roche Ltd, Basel, Switzerland.
Yi Meng ChangF. Hoffmann-La Roche Ltd, Mississauga, ON, Canada.
Anna Maria FinkDepartment I of Internal Medicine, Faculty of Medicine and University Hospital of Cologne, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, German Chronic Lymphocytic Leukemia Study Group, University of Cologne, Cologne, Germany.
Eugen TauschDivision of CLL, Department III of Internal Medicine, University Hospital Ulm, Ulm, Germany.
Christof SchneiderDivision of CLL, Department III of Internal Medicine, University Hospital Ulm, Ulm, Germany.
Matthias RitgenUniversitätsklinikum Schleswig Holstein, Kiel, Germany.
Karl-Anton KreuzerDepartment I of Internal Medicine, Faculty of Medicine and University Hospital of Cologne, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, German Chronic Lymphocytic Leukemia Study Group, University of Cologne, Cologne, Germany.
Liliya SivchevMultiprofile Hospital for Active Treatment Pazardjik, Pazardzhik, Bulgaria.
Carsten Utoft NiemannRigshospitalet, Copenhagen, Denmark.ORCID 0000-0001-9880-5242
Anthony SchwarerBox Hill Hospital, Box Hill, VIC, Australia.
Javier LoscertalesHospital De La Princesa, Madrid, Spain.ORCID 0000-0003-3561-3758
Robert WeinkoveTe Rerenga Ora Wellington Blood and Cancer Centre, Te Whatu Ora Health New Zealand Capital, Wellington, New Zealand.
Dirk StrumbergEvangelisches Krankenhaus Herne, Herne, Germany.
Allanah KilfoylePalmerston North Hospital, Palmerston North, New Zealand.
Beenish S ManzoorAbbVie Inc, Chicago, IL.
Dureshahwar JawaidAbbVie Inc, Chicago, IL.
Nnadozie EmechebeAbbVie Inc, Chicago, IL.
Jacob DevineGenentech Inc, South San Francisco, CA.
Michelle BoyerF. Hoffmann-La Roche Ltd, Welwyn, United Kingdom.
Eva D RunkelAbbVie Inc, Chicago, IL.
Barbara EichhorstDepartment I of Internal Medicine, Faculty of Medicine and University Hospital of Cologne, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, German Chronic Lymphocytic Leukemia Study Group, University of Cologne, Cologne, Germany.
Stephan StilgenbauerDivision of CLL, Department III of Internal Medicine, University Hospital Ulm, Ulm, Germany.
Yanwen JiangGenentech Inc, South San Francisco, CA.
Michael HallekDepartment I of Internal Medicine, Faculty of Medicine and University Hospital of Cologne, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, German Chronic Lymphocytic Leukemia Study Group, University of Cologne, Cologne, Germany.
Kirsten FischerDepartment I of Internal Medicine, Faculty of Medicine and University Hospital of Cologne, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, German Chronic Lymphocytic Leukemia Study Group, University of Cologne, Cologne, Germany.ORCID 0009-0006-6169-9152

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

abstractIn the CLL14 study, patients with previously untreated chronic lymphocytic leukemia (CLL) and coexisting conditions were randomized to 12 cycles of venetoclax-obinutuzumab (Ven-Obi, n = 216) or chlorambucil-obinutuzumab (Clb-Obi, n = 216). Progression-free survival (PFS) was the primary end point. Key secondary end points included time-to-next-treatment (TTNT), rates of undetectable minimal residual disease (uMRD), overall survival (OS), and rates of adverse events. Patient reported outcomes of time until definitive deterioration (TUDD) in quality of life (QoL) were analyzed. At a median observation time of 76.4 months, PFS remained superior for Ven-Obi compared with Clb-Obi (median, 76.2 vs 36.4 months; hazard ratio [HR], 0.40; 95% confidence interval [CI], 0.31-0.52; P < .0001). Likewise, TTNT was longer after Ven-Obi (6-year TTNT, 65.2% vs 37.1%; HR, 0.44; 95% CI, 0.33-0.58; P < .0001). In the Ven-Obi arm, presence of del(17p), unmutated immunoglobulin heavy-chain variable region, and lymph node size of ≥5 cm were independent prognostic factors for shorter PFS. The 6-year OS rate was 78.7% in the Ven-Obi and 69.2% in the Clb-Obi arm (HR, 0.69; 95% CI, 0.48-1.01; P = .052). A significantly longer TUDD in global health status/QoL was observed in the Ven-Obi than in the Clb-Obi arm (median, 82.1 vs 65.1 months; HR, 0.70; 95% CI, 0.51-0.97). Follow-up-adjusted second primary malignancies incidence rates were 2.3 and 1.4 per 1000 patient-months in the Ven-Obi and Clb-Obi arm, respectively. The sustained long-term survival and QoL benefits support the use of 1-year fixed-duration Ven-Obi in CLL. This trial was registered at www.ClinicalTrials.gov as #NCT02242942.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBridged Bicyclo Compounds, HeterocyclicLeukemia, Lymphocytic, Chronic, B-CellSulfonamidesAdultAgedAged, 80 and overFemaleHumansMaleMiddle AgedQuality of LifeAntibodies, Monoclonal, HumanizedBridged Bicyclo Compounds, HeterocyclicobinutuzumabSulfonamidesvenetoclax

Identifiers

PMID39082668
PMCPMC11551846

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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.