Evidence map›Paper›PMID 29241979›Full record

Trial reportLancet (London, England)2018

Acalabrutinib in relapsed or refractory mantle cell lymphoma (ACE-LY-004): a single-arm, multicentre, phase 2 trial.

Michael Wang, Simon Rule, Pier Luigi Zinzani, Andre Goy, Olivier Casasnovas, Stephen D Smith, Gandhi Damaj, Jeanette Doorduijn, Thierry Lamy, Franck Morschhauser and 19 more

2 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Lancet (London, England), 2018. 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 224 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
224citing papers in PubMed, 3 pooled it
30.0field-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.

NCT02213926 phase2active not recruitingnot on this map

An Open-label, Phase 2 Study of ACP-196 in Subjects With Mantle Cell Lymphoma

TypeinterventionalSponsorAcerta Pharma BVRan2015 to 2026Enrolled124ConditionsMantle Cell Lymphoma (MCL)ArmsACP-196 (acalabrutinib)
NCT03816683 completednot on this mapstarted 2019, after this paper: background citation

Treatment Patterns, Outcomes, and Patient-Reported Health-Related Quality of Life: A Prospective Disease Registry of Patients With Mantle Cell Lymphoma Treated With Novel Agents

TypeobservationalSponsorAstraZenecaRan2019 to 2024Enrolled227ConditionsMantle Cell Lymphoma
3 · Its place in the literature

Who cites it

224 citing papers in PubMed, 3 syntheses or guidelines pooled it, 433 citations in OpenAlex.

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  2. [The guideline of the diagnosis and treatment of mantle cell lymphoma in China (2022)].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2022
    Guideline
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164 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

29 authors at 19 institutions in 7 countries.

Michael WangDepartment of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX, USA; Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: miwang@mdanderson.org.
Simon RulePlymouth University Medical School, Plymouth, UK.
Pier Luigi ZinzaniInstitute of Hematology Seràgnoli, University of Bologna, Bologna, Italy.
Andre GoyJohn Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ, USA.
Olivier CasasnovasDepartment of Hematology, Centre Hospitalier Universitaire (CHU) de Dijon, INSERM UMR 1231, Dijon, France.
Stephen D SmithFred Hutchinson Cancer Research Center, University of Washington Seattle, WA, USA.
Gandhi DamajInstitut d'Hématologie de Basse-Normandie, Caen, France.
Jeanette DoorduijnErasmus Medical Centre, Rotterdam, The Netherlands; HOVON Lunenburg Lymphoma Phase I/II Consortium, Netherlands.
Thierry LamyCHU de Rennes, Rennes, France.
Franck MorschhauserUniveristé Lille, CHU Lille, EA 7365, Groupe de Recherche sur les formes Injectables et les Technologies Associées, Lille, France.
Carlos PanizoClínica Universidad de Navarra, Pamplona, Spain.
Bijal ShahH Lee Moffitt Cancer Center, Tampa, FL, USA.
Andrew DaviesCancer Research UK Centre, Cancer Sciences Unit, University of Southampton, Southampton, UK; Faculty of Medicine, Southampton General Hospital, Southampton, UK.
Richard EekBorder Medical Oncology, Wodonga, VIC, Australia.
Jehan DupuisUnité Hémopathies Lymphoïdes, Assistance Publique Hôpitaux de Paris, Hôpital Henri Mondor, Créteil, France.
Eric JacobsenDana Farber Cancer Institute, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.
Arnon P KaterHOVON Lunenburg Lymphoma Phase I/II Consortium, Netherlands; Academic Medical Center, Amsterdam, Netherlands.
Steven Le GouillCHU de Nantes, Hotel Dieu, Nantes, France; INSERM UMR 892 Team 10, Nantes, France.
Lucie ObericInstitut Universitaire du Cancer, Oncopole Toulouse (IUCT-O), Toulouse, France.
Taduesz RobakMedical University of Lodz, Copernicus Memorial Hospital, Lodz, Poland.
Todd CoveyAcerta Pharma, Redwood City, CA, USA.
Richa DuaAcerta Pharma, Redwood City, CA, USA.
Ahmed HamdyAcerta Pharma, Redwood City, CA, USA.
Xin HuangAcerta Pharma, Redwood City, CA, USA.
Raquel IzumiAcerta Pharma, Redwood City, CA, USA.
Priti PatelAcerta Pharma, Redwood City, CA, USA.
Wayne RothbaumAcerta Pharma, Redwood City, CA, USA.
J Greg SlatterAcerta Pharma, Redwood City, CA, USA.
Wojciech JurczakDepartment of Hematology, Jagiellonian University, Krakow, Poland.
Academic Medical Center · NLAssistance Publique – Hôpitaux de Paris · FRCentre d'Investigation Clinique de Nantes · FRCentre Hospitalier Universitaire de Rennes · FRCentre Hospitalier Universitaire Dijon Bourgogne · FRClinica Universidad de Navarra · ESDana-Farber Cancer Institute · USErasmus University Rotterdam · NLGroupe de Recherche sur les formes Injectables et les Technologies AssociéesHackensack University Medical Center · USInstitut universitaire du cancer de Toulouse Oncopole · FRJagiellonian University · PLMedical University of Lodz · PLMoffitt Cancer Center · USSouthampton General Hospital · GBThe University of Texas MD Anderson Cancer Center · USUniversity of Bologna · ITUniversity of Plymouth · GBUniversity of Washington · US

Funding

TRANSLATIONAL RESEARCHP30CA076292 · NCI · UNIVERSITY OF SOUTH FLORIDA · PI Christine O'Connell · 1998 to 2026
$93.5M
NCI NIH HHS P30 CA076292
6 · The paper itself

Abstract

backgroundBruton tyrosine kinase is a clinically validated target in mantle cell lymphoma. Acalabrutinib (ACP-196) is a highly selective, potent Bruton tyrosine kinase inhibitor developed to minimise off-target activity.

methodsIn this open-label, phase 2 study, oral acalabrutinib (100 mg twice per day) was given to patients with relapsed or refractory mantle cell lymphoma, until disease progression or unacceptable toxicity. The primary endpoint was overall response assessed according to the Lugano classification, and safety analyses were done in all participants. This trial is registered with ClinicalTrials.gov, number NCT02213926.

findingsFrom March 12, 2015, to Jan 5, 2016, 124 patients with relapsed or refractory mantle cell lymphoma were enrolled and all patients received treatment; median age 68 years. Patients received a median of two (IQR 1-2) previous therapies. At a median follow-up of 15·2 months, 100 (81%) patients achieved an overall response and 49 (40%) patients achieved a complete response. The Kaplan-Meier estimated medians for duration of response, progression-free survival, and overall survival were not reached; the 12-month rates were 72% (95% CI 62-80), 67% (58-75), and 87% (79-92%), respectively. The most common adverse events were primarily grade 1 or 2 and were headache (47 [38%]), diarrhoea (38 [31%]), fatigue (34 [27%]), and myalgia (26 [21%]). The most common grade 3 or worse adverse events were neutropenia (13 [10%]), anaemia (11 [9%]), and pneumonia (six [5%]). There were no cases of atrial fibrillation and one case of grade 3 or worse haemorrhage. The median duration of treatment was 13·8 months. Treatment was discontinued in 54 (44%) patients, primarily due to progressive disease (39 [31%]) and adverse events (seven [6%]).

interpretationAcalabrutinib treatment provided a high rate of durable responses and a favourable safety profile in patients with relapsed or refractory mantle cell lymphoma. These findings suggest an important role for acalabrutinib in the treatment of this disease population.

fundingAcerta Pharma, a member of the AstraZeneca Group.

Indexed as

AgedBenzamidesDose-Response Relationship, DrugFemaleHumansLymphoma, Mantle-CellMaleMiddle AgedProtein Kinase InhibitorsPyrazinesRecurrenceSurvival AnalysisTreatment OutcomeacalabrutinibBenzamidesProtein Kinase InhibitorsPyrazines

Identifiers

PMID29241979
PMCPMC7864374
OpenAlexW2774522106

What OpenQuestion holds

Textmetadata
LicenceTDM
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.