Evidence map›Paper›PMID 37072421›Full record

Trial reportNature communications2023

Transcriptomic profiles and 5-year results from the randomized CLL14 study of venetoclax plus obinutuzumab versus chlorambucil plus obinutuzumab in chronic lymphocytic leukemia.

Othman Al-Sawaf, Can Zhang, Hyun Yong Jin, Sandra Robrecht, Yoonha Choi, Sandhya Balasubramanian, Alex Kotak, Yi Meng Chang, Anna Maria Fink, Eugen Tausch and 13 more

Erratum issued Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Nature communications, 2023. 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 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 47 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 2 pooled it
25.0field-weighted citation impact, top 1% 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.

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

47 citing papers in PubMed, 2 syntheses or guidelines pooled it, 88 citations in OpenAlex.

  1. Pooled it
  2. End Point Surrogacy in First-Line Chronic Lymphocytic Leukemia.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025
    Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Article
  8. Review
  9. Article
  10. Review
  11. Review
  12. Is CLL curable?HemaSphere · 2026
    Article
  13. Review
  14. Article
  15. Article
  16. Updates in the management of newly diagnosed chronic lymphocytic leukemia.Hematology. American Society of Hematology. Education Program · 2025
    Review
  17. Article
  18. Article
  19. Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

23 authors at 6 institutions in 4 countries.

Othman Al-SawafUniversity of Cologne, Faculty of Medicine and University Hospital Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, Cologne, Germany. othman.al-sawaf@uk-koeln.de.ORCID http://orcid.org/0000-0001-9895-0570
Can ZhangUniversity of Cologne, Faculty of Medicine and University Hospital Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, Cologne, Germany.
Hyun Yong JinGenentech Inc., South San Francisco, CA, USA.
Sandra RobrechtUniversity of Cologne, Faculty of Medicine and University Hospital Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, Cologne, Germany.
Yoonha ChoiGenentech Inc., South San Francisco, CA, USA.
Sandhya BalasubramanianGenentech Inc., South San Francisco, CA, USA.
Alex KotakRoche Products Ltd, Welwyn Garden City, UK.
Yi Meng ChangHoffmann-la Roche, Mississauga, ON, Canada.
Anna Maria FinkUniversity of Cologne, Faculty of Medicine and University Hospital Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, Cologne, Germany.
Eugen TauschDepartment III of Internal Medicine, Ulm University, Ulm, Germany.
Christof SchneiderDepartment III of Internal Medicine, Ulm University, Ulm, Germany.
Matthias RitgenDepartment II of Internal Medicine, University of Schleswig Holstein, Kiel, Germany.
Karl-Anton KreuzerUniversity of Cologne, Faculty of Medicine and University Hospital Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, Cologne, Germany.
Brenda ChylaAbbVie Inc., North Chicago, IL, USA.
Joseph N PaulsonGenentech Inc., South San Francisco, CA, USA.
Christian P PallaschUniversity of Cologne, Faculty of Medicine and University Hospital Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, Cologne, Germany.ORCID http://orcid.org/0000-0001-5675-6905
Lukas P FrenzelUniversity of Cologne, Faculty of Medicine and University Hospital Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, Cologne, Germany.
Martin PeiferUniversity of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Translational Genomics, Cologne, Germany.ORCID http://orcid.org/0000-0002-5243-5503
Barbara EichhorstUniversity of Cologne, Faculty of Medicine and University Hospital Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, Cologne, Germany.
Stephan StilgenbauerDepartment III of Internal Medicine, Ulm University, Ulm, Germany.ORCID http://orcid.org/0000-0002-6830-9296
Yanwen JiangGenentech Inc., South San Francisco, CA, USA.
Michael HallekUniversity of Cologne, Faculty of Medicine and University Hospital Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, Cologne, Germany. michael.hallek@uni-koeln.de.ORCID http://orcid.org/0000-0002-7425-4455
Kirsten FischerUniversity of Cologne, Faculty of Medicine and University Hospital Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, Cologne, Germany. kirsten.fischer@uk-koeln.de.ORCID http://orcid.org/0009-0006-6169-9152
University of Cologne · DEUniversität Ulm · DEAbbVie (United States) · USChristian-Albrechts-Universität zu Kiel · DERoche (Canada) · CARoche (United Kingdom) · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Data on long-term outcomes and biological drivers associated with depth of remission after BCL2 inhibition by venetoclax in the treatment of chronic lymphocytic leukemia (CLL) are limited. In this open-label parallel-group phase-3 study, 432 patients with previously untreated CLL were randomized (1:1) to receive either 1-year venetoclax-obinutuzumab (Ven-Obi, 216 patients) or chlorambucil-Obi (Clb-Obi, 216 patients) therapy (NCT02242942). The primary endpoint was investigator-assessed progression-free survival (PFS); secondary endpoints included minimal residual disease (MRD) and overall survival. RNA sequencing of CD19-enriched blood was conducted for exploratory post-hoc analyses. After a median follow-up of 65.4 months, PFS is significantly superior for Ven-Obi compared to Clb-Obi (Hazard ratio [HR] 0.35 [95% CI 0.26-0.46], p < 0.0001). At 5 years after randomization, the estimated PFS rate is 62.6% after Ven-Obi and 27.0% after Clb-Obi. In both arms, MRD status at the end of therapy is associated with longer PFS. MRD + ( ≥ 10

Indexed as

Leukemia, Lymphocytic, Chronic, B-CellAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBridged Bicyclo Compounds, HeterocyclicChlorambucilHumansSulfonamidesTranscriptomeAntibodies, Monoclonal, HumanizedBridged Bicyclo Compounds, HeterocyclicChlorambucilobinutuzumabSulfonamidesvenetoclax

Identifiers

PMID37072421
PMCPMC10113251
OpenAlexW4366280595

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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.