Evidence map›Paper›PMID 31621094›Full record

Trial reportAmerican journal of hematology2020

Safety and activity of ibrutinib in combination with durvalumab in patients with relapsed or refractory follicular lymphoma or diffuse large B-cell lymphoma.

Alex F Herrera, Andre Goy, Amitkumar Mehta, Radhakrishnan Ramchandren, John M Pagel, Jakub Svoboda, Shanhong Guan, John S Hill, Kevin Kwei, Emily A Liu and 1 more

Open access · hybridAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in American journal of hematology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 45 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 4 pooled it
5.1field-weighted citation impact, top 4% 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.

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

45 citing papers in PubMed, 4 syntheses or guidelines pooled it, 61 citations in OpenAlex.

  1. Pooled it
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  14. Diffuse large B-cell lymphoma.Hematological oncology · 2024
    Review
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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 at 8 institutions in 1 country.

Alex F HerreraDepartment of Hematology/Hematopoietic Cell Transplantation, City of Hope National Medical Center, Duarte, California.ORCID 0000-0002-9665-7415
Andre GoyJohn Theurer Cancer Center Division of Lymphoma, Hackensack University Medical Center, Hackensack, New Jersey.
Amitkumar MehtaDivision of Hematology and Oncology, University of Alabama, Birmingham, Alabama.
Radhakrishnan RamchandrenDepartment of Hematology/Oncology, Karmanos Cancer Institute, Detroit, Michigan.
John M PagelCenter for Blood Disorders and Stem Cell Transplantation, Division of Oncology, Swedish Cancer Institute, Seattle, Washington.
Jakub SvobodaDepartment of Medicine, Division of Hematology and Oncology, University of Pennsylvania, Philadelphia, Pennsylvania.
Shanhong GuanDepartment of Biostatistics, Pharmacyclics LLC, an AbbVie Company, Sunnyvale, California.
John S HillDepartment of Translational Medicine, Pharmacyclics LLC, an AbbVie Company, Sunnyvale, California.
Kevin KweiDepartment of Translational Medicine, Pharmacyclics LLC, an AbbVie Company, Sunnyvale, California.
Emily A LiuDepartment of Clinical Science, Pharmacyclics LLC, an AbbVie Company, Sunnyvale, California.
Tycel PhillipsRogel Cancer Center, Division of Hematology and Oncology, University of Michigan, Ann Arbor, Michigan.
AbbVie (United States) · USCity Of Hope National Medical Center · USHackensack University Medical Center · USSwedish Medical Center · USThe Barbara Ann Karmanos Cancer Institute · USUniversity of Alabama at Birmingham · USUniversity of Michigan · USUniversity of Pennsylvania · US

Funding

Tumor Biology and Microenvironment (Program 1)P30CA022453 · NCI · WAYNE STATE UNIVERSITY · PI Julie Lynn Boerner · 1985 to 2026
$68.4M
Transplant for Lymphoma:Therapy-Related LeukemiaP50CA107399 · NCI · CITY OF HOPE/BECKMAN RESEARCH INSTITUTE · PI KWAK, LARRY W · 2004 to 2022
$35.5M
Oncology Research Career Development ProgramK12CA001727 · NCI · CITY OF HOPE NATIONAL MEDICAL CENTER · PI MORTIMER, JOANNE E. · 1992 to 2024
$14.6M
NCI NIH HHS K12 CA001727NCI NIH HHS P30 CA022453NCI NIH HHS P50 CA107399Pharmacyclics LLC, an AbbVie Company
6 · The paper itself

Abstract

This phase 1b/2, multicenter, open-label study evaluated ibrutinib plus durvalumab in relapsed/refractory follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL). Patients were treated with once-daily ibrutinib 560 mg plus durvalumab 10 mg/kg every 2 weeks in 28-day cycles in phase 1b without dose-limiting toxicities, confirming the phase 2 dosing. Sixty-one patients with FL (n = 27), germinal center B-cell (GCB) DLBCL (n = 16), non-GCB DLBCL (n = 16), and unspecified DLBCL (n = 2) were treated. Overall response rate (ORR) was 25% in all patients, 26% in patients with FL, 13% in patients with GCB DLBCL, and 38% in patients with non-GCB DLBCL. Overall, median progression-free survival was 4.6 months and median overall survival was 18.1 months; both were longer in patients with FL than in patients with DLBCL. The most frequent treatment-emergent adverse events (AEs) in patients with FL and DLBCL, respectively, were diarrhea (16 [59%]; 16 [47%]), fatigue (12 [44%]; 16 [47%]), nausea (9 [33%]; 12 [35%]), peripheral edema (7 [26%]; 13 [38%]), decreased appetite (8 [30%]; 11 [32%]), neutropenia (6 [22%]; 11 [32%]), and vomiting (5 [19%]; 12 [35%]). Investigator-defined immune-related AEs were reported in 12/61 (20%) patients. Correlative analyses were conducted but did not identify any conclusive biomarkers of response. In FL, GCB DLBCL, and non-GCB DLBCL, ibrutinib plus durvalumab demonstrated similar activity to single-agent ibrutinib with the added toxicity of the PD-L1 blockade; the combination resulted in a safety profile generally consistent with those known for each individual agent.

Indexed as

AdenineAdultAgedAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsFemaleHumansLymphoma, FollicularLymphoma, Large B-Cell, DiffuseMaleMiddle AgedPiperidinesPyrazolesPyrimidinesSalvage TherapySurvival AnalysisAdenineAntibodies, MonoclonaldurvalumabibrutinibPiperidinesPyrazolesPyrimidines

Identifiers

PMID31621094
PMCPMC6904508
OpenAlexW2981143297

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

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.