Evidence map›Paper›PMID 30901302›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2019

Randomized Phase III Trial of Ibrutinib and Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Non-Germinal Center B-Cell Diffuse Large B-Cell Lymphoma.

Anas Younes, Laurie H Sehn, Peter Johnson, Pier Luigi Zinzani, Xiaonan Hong, Jun Zhu, Caterina Patti, David Belada, Olga Samoilova, Cheolwon Suh and 21 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06251180 (A Phase Ib Study to Assess Safety and Preliminary Efficacy of Rocbrutinib in Combination With R-CHOP in Patients With Newly Diagnosed B-NHL), which is not on this map. Cited by 335 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
335citing papers in PubMed, 7 pooled it
48.6field-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.

NCT06251180 phase1recruitingnot on this mapstarted 2024, after this paper: background citation

A Phase Ib Study to Assess Safety and Preliminary Efficacy of Rocbrutinib in Combination With R-CHOP in Patients With Newly Diagnosed B-NHL

TypeinterventionalSponsorGuangzhou Lupeng Pharmaceutical Company LTD.Ran2024 to 2029Enrolled112ConditionsB-cell Non-Hodgkin LymphomaArmsRocbrutinib, Rituximab, Cyclophosphamide, doxorubicin, Vincristin
3 · Its place in the literature

Who cites it

335 citing papers in PubMed, 7 syntheses or guidelines pooled it, 600 citations in OpenAlex.

  1. Pooled it
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  3. SEOM-GOTEL clinical guidelines on diffuse large B-cell lymphoma (update 2025).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025
    Guideline
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275 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

31 authors at 20 institutions in 18 countries.

Anas Younes1 Memorial Sloan Kettering Cancer Center, New York, NY.
Laurie H Sehn2 BC Cancer Agency, Vancouver, British Columbia, Canada.
Peter Johnson3 University of Southampton, Southampton, United Kingdom.
Pier Luigi Zinzani4 "Seràgnoli" University of Bologna, Bologna, Italy.
Xiaonan Hong5 Fudan University, Shanghai, People's Republic of China.
Jun Zhu6 Peking University Cancer Hospital, Beijing, People's Republic of China.
Caterina Patti7 Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello, Palermo, Italy.
David Belada8 Charles University, Hradec Králové, Czech Republic.
Olga Samoilova10 Regional Clinical Hospital, Nizhny Novgorod, Russian Federation.
Cheolwon Suh11 University of Ulsan, Seoul, Republic of Korea.
Sirpa Leppä12 Helsinki University Hospital, Helsinki, Finland.
Shinya Rai14 Kindai University, Osakasayama, Japan.
Mehmet Turgut15 Ondokuz Mayis University, Samsun, Turkey.
Wojciech Jurczak16 Jagiellonian University, Krakow, Poland.
Matthew C Cheung17 Sunnybrook Odette Cancer Centre, Toronto, Ontario, Canada.
Ronit Gurion18 Rabin Medical Center, Petah Tikva, Israel.
Su-Peng Yeh20 China Medical University Hospital, Taichung, Republic of China.
Andres Lopez-Hernandez21 University Hospital Vall d'Hebron, Barcelona, Spain.
Ulrich Dührsen22 University Hospital Essen, Essen, Germany.
Catherine Thieblemont23 Hôpital Saint-Louis, Paris, France.
Carlos Sergio Chiattone25 Santa Casa Medical School, São Paulo, Brazil.
Sriram Balasubramanian26 Janssen Research and Development, San Diego, CA.
Jodi Carey27 Janssen Research and Development, Spring House, PA.
Grace Liu28 Janssen Research and Development, Raritan, NJ.
S Martin Shreeve26 Janssen Research and Development, San Diego, CA.
Steven Sun28 Janssen Research and Development, Raritan, NJ.
Sen Hong Zhuang28 Janssen Research and Development, Raritan, NJ.
Jessica Vermeulen29 Janssen Research and Development, Leiden, the Netherlands.
Louis M Staudt30 National Cancer Institute, National Institutes of Health, Bethesda, MD.
Wyndham Wilson30 National Cancer Institute, National Institutes of Health, Bethesda, MD.
PHOENIX investigators
Janssen (United States) · USBC Cancer Agency · CACharles University · CZChina Medical University · TWDélégation Paris 7 · FREssen University Hospital · DEFudan University · CNHelsinki University Hospital · FIJagiellonian University · PLJanssen (Netherlands) · NLKindai University · JPMemorial Sloan Kettering Cancer Center · USNational Cancer Institute · USNational Institutes of Health · USNizhny Novgorod Regional Clinical Hospital named after Semashko · RUOndokuz Mayıs University · TROspedale Vincenzo Cervello · ITPeking University · CNRabin Medical Center · ILSunnybrook Health Science Centre · CA

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
Targeted treatment of B-cell LymphomaZIABC011354 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI WILSON, WYNDHAM H · 2010 to 2025
$4.6M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

purposeIbrutinib has shown activity in non-germinal center B-cell diffuse large B-cell lymphoma (DLBCL). This double-blind phase III study evaluated ibrutinib and rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in untreated non-germinal center B-cell DLBCL. PATIENTS AND

methodsPatients were randomly assigned at a one-to-one ratio to ibrutinib (560 mg per day orally) plus R-CHOP or placebo plus R-CHOP. The primary end point was event-free survival (EFS) in the intent-to-treat (ITT) population and the activated B-cell (ABC) DLBCL subgroup. Secondary end points included progression-free survival (PFS), overall survival (OS), and safety.

resultsA total of 838 patients were randomly assigned to ibrutinib plus R-CHOP (n = 419) or placebo plus R-CHOP (n = 419). Median age was 62.0 years; 75.9% of evaluable patients had ABC subtype disease, and baseline characteristics were balanced. Ibrutinib plus R-CHOP did not improve EFS in the ITT (hazard ratio [HR], 0.934) or ABC (HR, 0.949) population. A preplanned analysis showed a significant interaction between treatment and age. In patients age younger than 60 years, ibrutinib plus R-CHOP improved EFS (HR, 0.579), PFS (HR, 0.556), and OS (HR, 0.330) and slightly increased serious adverse events (35.7%

conclusionThe study did not meet its primary end point in the ITT or ABC population. However, in patients age younger than 60 years, ibrutinib plus R-CHOP improved EFS, PFS, and OS with manageable safety. In patients age 60 years or older, ibrutinib plus R-CHOP was associated with increased toxicity, leading to compromised R-CHOP administration and worse outcomes. Further investigation is warranted.

Indexed as

AdenineAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCyclophosphamideDouble-Blind MethodDoxorubicinFemaleHumansKaplan-Meier EstimateLymphoma, Large B-Cell, DiffuseMaleMiddle AgedPiperidinesPlacebosAdenineCyclophosphamideDoxorubicinibrutinibPiperidinesPlacebosPrednisonePyrazolesPyrimidinesR-CHOP protocolRituximabVincristine

Identifiers

PMID30901302
PMCPMC6553835
OpenAlexW2923453543

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.