Evidence map›Paper›PMID 32209572›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2020

Ibrutinib Treatment for First-Line and Relapsed/Refractory Chronic Lymphocytic Leukemia: Final Analysis of the Pivotal Phase Ib/II PCYC-1102 Study.

John C Byrd, Richard R Furman, Steven E Coutre, Ian W Flinn, Jan A Burger, Kristie Blum, Jeff P Sharman, William Wierda, Weiqiang Zhao, Nyla A Heerema and 4 more

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

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2020. 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 119 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
119citing papers in PubMed, 3 pooled it
15.8field-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.

NCT01105247 phase1 / phase2completednot on this map

A Phase 1b/2 Fixed-dose Study of Bruton's Tyrosine Kinase (Btk) Inhibitor, PCI-32765, in Chronic Lymphocytic Leukemia

TypeinterventionalSponsorPharmacyclics LLC.Ran2010 to 2013Enrolled133ConditionsB-cell Chronic Lymphocytic Leukemia, Small Lymphocytic LymphomaArmsPCI-32765
NCT01109069 phase2completednot on this map

A Long-term Safety Study of Bruton's Tyrosine Kinase (Btk) Inhibitor PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia

TypeinterventionalSponsorPharmacyclics LLC.Ran2010 to 2019Enrolled199ConditionsB-cell Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Diffuse Well-differentiated Lymphocytic Lymphoma, B Cell LymphomaArmsPCI-32765
3 · Its place in the literature

Who cites it

119 citing papers in PubMed, 3 syntheses or guidelines pooled it, 179 citations in OpenAlex.

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59 more citing papers are in PubMed but not listed here.

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 7 institutions in 1 country.

John C ByrdDepartment of Internal Medicine, The Ohio State University Medical Center, Columbus, Ohio. john.byrd@osumc.edu.
Richard R FurmanDepartment of Medicine, Weill Cornell Medical College/New York Presbyterian Hospital, New York, New York.
Steven E CoutreDepartment of Medicine Hematology, Stanford Cancer Center, Stanford University School of Medicine, Stanford, California.
Ian W FlinnHematology/Oncology, Sarah Cannon Research Institute/Tennessee Oncology, Nashville, Tennessee.
Jan A BurgerDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Kristie BlumDepartment of Internal Medicine, The Ohio State University Medical Center, Columbus, Ohio.
Jeff P SharmanMedical Oncology Division, Willamette Valley Cancer Institute and Research Center/US Oncology Research, Eugene, Oregon.
William WierdaDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Weiqiang ZhaoDepartment of Pathology, The Ohio State University, Columbus, Ohio.
Nyla A HeeremaDepartment of Pathology, The Ohio State University, Columbus, Ohio.
Ying LuanDepartment of Biostatistics, Pharmacyclics LLC, an AbbVie Company, Sunnyvale, California.
Emily A LiuDepartment of Clinical Sciences, Pharmacyclics LLC, an AbbVie Company, Sunnyvale, California.
James P DeanDepartment of Clinical Sciences, Pharmacyclics LLC, an AbbVie Company, Sunnyvale, California.
Susan O'BrienDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
The Ohio State University · USPharmacyclics (United States) · USThe University of Texas MD Anderson Cancer Center · USCornell University · USStanford Medicine · USTennessee Oncology · USWillamette Valley Cancer Institute and Research Center · US

Funding

Targeted Therapy for LeukemiaR35CA197734 · NCI · UNIVERSITY OF CINCINNATI · PI BYRD, JOHN C. · 2015 to 2021
$6.6M
Improving BTK Directed Therapy for CLLR01CA197870 · NCI · OHIO STATE UNIVERSITY · PI WOYACH, JENNIFER A. · 2015 to 2019
$1.8M
NCI NIH HHS R01 CA197870NCI NIH HHS R35 CA197734
6 · The paper itself

Abstract

purposeThe safety and efficacy of ibrutinib, a once-daily Bruton's tyrosine kinase (BTK) inhibitor, in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) was demonstrated in this phase Ib/II study. Extended follow-up up to 8 years is described, representing the longest follow-up for single-agent ibrutinib, or any BTK inhibitor, to date. PATIENTS AND

methodsPhase Ib/II PCYC-1102 (NCT01105247) and extension study PCYC-1103 (NCT01109069) included patients receiving single-agent ibrutinib in first-line or relapsed/refractory CLL/SLL.

resultsOverall response rate was 89%, with similar rates in first-line (87%; complete response, 35%) and relapsed/refractory settings (89%; 10%). Estimated 7-year progression-free survival (PFS) rates were 83% in first-line and 34% in relapsed/refractory settings. Forty-one patients had CLL progression (

conclusionsWith up to 8 years of follow-up, sustained responses and long-term tolerability of single-agent ibrutinib were observed with treatment of first-line or relapsed/refractory CLL/SLL, including high-risk CLL/SLL.

Indexed as

AdenineAdultAgammaglobulinaemia Tyrosine KinaseAgedAged, 80 and overDisease-Free SurvivalDose-Response Relationship, DrugDrug Administration ScheduleDrug Resistance, NeoplasmFemaleFollow-Up StudiesHumansHypertensionLeukemia, Lymphocytic, Chronic, B-CellMaleMiddle AgedAdenineAgammaglobulinaemia Tyrosine KinaseBTK protein, humanibrutinibPiperidines

Identifiers

PMID32209572
PMCPMC8175012
OpenAlexW3013074397

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.