Evidence map›Paper›PMID 34380643›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2021

Single-Agent Ibrutinib for Rituximab-Refractory Waldenström Macroglobulinemia: Final Analysis of the Substudy of the Phase III Innovate

Judith Trotman, Christian Buske, Alessandra Tedeschi, Jeffrey V Matous, David MacDonald, Constantine S Tam, Olivier Tournilhac, Shuo Ma, Steven P Treon, Albert Oriol and 4 more

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02165397 (iNNOVATE Study), which is not on this map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
–field-weighted citation impact
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.

NCT02165397 phase3completednot on this map

iNNOVATE Study: A Randomized, Double-Blind, Placebo- Controlled, Phase 3 Study of Ibrutinib or Placebo in Combination With Rituximab in Subjects With Waldenström's Macroglobulinemia

TypeinterventionalSponsorPharmacyclics LLC.Ran2014 to 2019Enrolled181ConditionsWaldenström's MacroglobulinemiaArmsIbrutinib, Placebo, Rituximab
3 · Its place in the literature

Who cites it

22 citing papers in PubMed.

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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.

Judith TrotmanConcord Hospital, University of Sydney, Concord, New South Wales, Australia. judith.trotman@health.nsw.gov.au.ORCID 0000-0001-8009-4593
Christian BuskeComprehensive Cancer Center Ulm and Institute of Experimental Cancer Research, University Hospital of Ulm, Ulm, Germany.
Alessandra TedeschiASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.
Jeffrey V MatousColorado Blood Cancer Institute, Denver, Colorado.
David MacDonaldThe Ottawa Hospital, University of Ottawa, Ottawa, Ontario, Canada.
Constantine S TamSt. Vincent's Hospital, Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, Victoria, Australia.
Olivier TournilhacHématologie Clinique Adulte et Thérapie Cellulaire, CHU Hotel Dieu Hématologie, Clermont-Ferrand, France.
Shuo MaRobert H. Lurie Comprehensive Cancer Center, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
Steven P TreonDana-Farber Cancer Institute, Boston, Massachusetts.
Albert OriolInstitut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Barcelona, Spain.
Jerry PingPharmacyclics LLC, an AbbVie Company, Sunnyvale, California.
Eva M BrisoPharmacyclics Switzerland GmbH, an AbbVie Company, Schaffhausen, Switzerland.
Israel Arango-HisijaraPharmacyclics LLC, an AbbVie Company, Sunnyvale, California.
Meletios A DimopoulosNational and Kapodistrian University of Athens School of Medicine, Athens, Greece.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe first report from the open-label substudy of the phase III iNNOVATE study (PCYC-1127; NCT02165397) demonstrated that single-agent ibrutinib was efficacious and well tolerated in patients with heavily pretreated, rituximab-refractory Waldenström macroglobulinemia. Results from the final analysis are now reported. PATIENTS AND

methodsIbrutinib 420 mg was administered once daily to patients (

resultsAfter a median follow-up of 58 months (range: 9-61), median PFS was 39 months [95% confidence interval (CI): 25-not evaluable]; 60-month PFS rate was 40%. In MYD88

conclusionsIn the final analysis from iNNOVATE, single-agent ibrutinib continued to show sustained efficacy in patients with heavily pretreated, rituximab-refractory Waldenström macroglobulinemia.

Indexed as

AdenineAgedAged, 80 and overAntineoplastic Agents, ImmunologicalHumansMiddle AgedPiperidinesRituximabTreatment FailureWaldenstrom MacroglobulinemiaAdenineAntineoplastic Agents, ImmunologicalibrutinibPiperidinesRituximab

Identifiers

PMID34380643
PMCPMC9401517

What OpenQuestion holds

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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.