Evidence map›Paper›PMID 34152395›Full record

Trial reportBlood advances2021

Zanubrutinib for the treatment of relapsed or refractory mantle cell lymphoma.

Constantine S Tam, Stephen Opat, David Simpson, Gavin Cull, Javier Munoz, Tycel J Phillips, Won Seog Kim, Simon Rule, Siminder Kaur Atwal, Rachel Wei and 4 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Blood advances, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 59 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
59citing papers in PubMed, 2 pooled it
11.3field-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.

NCT02343120 phase1 / phase2completednot on this map

A Phase I/II, Open-Label, Multiple-Dose, Dose Escalation and Expansion Study to Investigate the Safety and Pharmacokinetics of the BTK Inhibitor BGB-3111 in Subjects With B-Cell Lymphoid Malignancies

TypeinterventionalSponsorBeiGeneRan2014 to 2021Enrolled385ConditionsB-cell MalignanciesArmsZanubrutinib
NCT03206970 phase2completednot on this map

A Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate Efficacy and Safety of BGB-3111, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (MCL)

TypeinterventionalSponsorBeiGeneRan2017 to 2020Enrolled86ConditionsRefractory Mantle Cell Lymphoma, Relapsed Mantle Cell LymphomaArmsZanubrutinib
3 · Its place in the literature

Who cites it

59 citing papers in PubMed, 2 syntheses or guidelines pooled it, 97 citations in OpenAlex.

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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

14 authors at 9 institutions in 5 countries.

Constantine S TamPeter MacCallum Cancer Centre, Melbourne, VIC, Australia.
Stephen OpatMonash Health, Clayton, VIC, Australia.
David SimpsonNorth Shore Hospital, Auckland, New Zealand.
Gavin CullSir Charles Gairdner Hospital, Perth, WA, Australia.
Javier MunozBanner MD Anderson Cancer Center, Gilbert, AZ.
Tycel J PhillipsDivision of Hematology and Oncology, University of Michigan, Ann Arbor, MI.
Won Seog KimSamsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Simon RulePeninsula Medical School, University of Plymouth, Plymouth, United Kingdom.
Siminder Kaur AtwalBeiGene USA, Inc., San Mateo, CA.
Rachel WeiBeiGene USA, Inc., San Mateo, CA.
William NovotnyBeiGene USA, Inc., San Mateo, CA.
Jane HuangBeiGene USA, Inc., San Mateo, CA.
Michael WangThe University of Texas MD Anderson Cancer Center, Houston, TX; and.ORCID 0000-0001-9748-5486
Judith TrotmanConcord Repatriation Hospital, The University of Sydney, Sydney, NSW, Australia.ORCID 0000-0001-8009-4593
The University of Texas MD Anderson Cancer Center · USMonash Health · AUNorth Shore Hospital · NZSamsung Medical Center · KRThe Royal Melbourne Hospital · AUThe University of Sydney · AUThe University of Western Australia · AUUniversity of Michigan · USUniversity of Plymouth · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Zanubrutinib, a highly selective Bruton tyrosine kinase inhibitor, was evaluated in a phase 1/2 study in patients with various B-cell malignancies. In the subgroup of patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL), zanubrutinib was administered as 160 mg twice daily (n = 14), 320 mg once daily (n = 18), or ≤160 mg total dose (n = 5). Herein, we report results for patients receiving a total daily dose of 320 mg (N = 32). Median study follow-up was 18.8 months. Eighteen patients discontinued treatment, 10 because of progressive disease and 8 because of adverse events (AEs); 1 AE (peripheral edema) was considered to be related to zanubrutinib treatment. The most common AEs were diarrhea (43.8%), contusion (37.5%), constipation (31.3%), and upper respiratory tract infection (31.3%). Infection was the most commonly reported AE of interest (18.8% of patients experienced grade ≥3 infection). At least 1 AE of grade ≥3 was reported in 59.4% of patients; grade ≥3 AEs that were reported in >2 patients were anemia (12.5%), pneumonia (9.4%), and myalgia (9.4%). Overall response rate was 84%, with 25% achieving a complete response. Median duration of response was 18.5 months. Median progression-free survival (PFS) was 21.1 months. Zanubrutinib was well tolerated and demonstrated activity in patients with R/R MCL. The trial is registered at www.clinicaltrials.gov as #NCT02343120.

Indexed as

Lymphoma, Mantle-CellAdultHumansPiperidinesPyrazolesPyrimidinesPiperidinesPyrazolesPyrimidineszanubrutinib

Identifiers

PMID34152395
PMCPMC8270663
OpenAlexW3176433809

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.