Evidence map›Paper›PMID 31915195›Full record

Trial reportCancer discovery2020

Acalabrutinib plus Obinutuzumab in Treatment-Naïve and Relapsed/Refractory Chronic Lymphocytic Leukemia.

Jennifer A Woyach, James S Blachly, Kerry A Rogers, Seema A Bhat, Mojgan Jianfar, Gerard Lozanski, David M Weiss, Barbara L Andersen, Michael Gulrajani, Melanie M Frigault and 6 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Cancer discovery, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02296918 (A Phase 1b Study of ACP-196 in Combination With Obinutuzumab for Patients With Relapsed / Refractory or Untreated CLL/SLL/PLL), which is not on this map. Cited by 48 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 1 pooled it
8.5field-weighted citation impact, top 2% 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.

NCT02296918 phase1completednot on this map

A Phase 1b Study of ACP-196 in Combination With Obinutuzumab for Patients With Relapsed / Refractory or Untreated CLL/SLL/PLL

TypeinterventionalSponsorAcerta Pharma BVRan2014 to 2025Enrolled69ConditionsChronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Prolymphocytic LeukemiaArmsacalabrutinib, Obinutuzumab, Venetoclax, Rituximab
3 · Its place in the literature

Who cites it

48 citing papers in PubMed, 1 synthesis or guideline pooled it, 79 citations in OpenAlex.

  1. Pooled it
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  5. Observational
  6. Review
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  15. Measurable Residual Disease Monitoring in Lymphoma.Current hematologic malignancy reports · 2023
    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

16 authors at 2 institutions in 2 countries.

Jennifer A WoyachThe Ohio State University Comprehensive Cancer Center, Columbus, Ohio. jennifer.woyach@osumc.edu.
James S BlachlyThe Ohio State University Comprehensive Cancer Center, Columbus, Ohio.ORCID https://orcid.org/0000-0002-4275-5562
Kerry A RogersThe Ohio State University Comprehensive Cancer Center, Columbus, Ohio.
Seema A BhatThe Ohio State University Comprehensive Cancer Center, Columbus, Ohio.
Mojgan JianfarThe Ohio State University Comprehensive Cancer Center, Columbus, Ohio.
Gerard LozanskiThe Ohio State University Comprehensive Cancer Center, Columbus, Ohio.
David M WeissThe Ohio State University Comprehensive Cancer Center, Columbus, Ohio.
Barbara L AndersenThe Ohio State University Comprehensive Cancer Center, Columbus, Ohio.ORCID https://orcid.org/0000-0002-7335-1325
Michael GulrajaniAcerta Pharma, a member of the AstraZeneca Group, South San Francisco, California.
Melanie M FrigaultAcerta Pharma, a member of the AstraZeneca Group, South San Francisco, California.
Ahmed HamdyAcerta Pharma, a member of the AstraZeneca Group, South San Francisco, California.
Raquel IzumiAcerta Pharma, a member of the AstraZeneca Group, South San Francisco, California.
Veerendra MunugalavadlaAcerta Pharma, a member of the AstraZeneca Group, South San Francisco, California.
Cheng QuahAcerta Pharma, a member of the AstraZeneca Group, South San Francisco, California.
Min-Hui WangAcerta Pharma, a member of the AstraZeneca Group, South San Francisco, California.
John C ByrdThe Ohio State University Comprehensive Cancer Center, Columbus, Ohio.
The Ohio State University · USAstraZeneca (Poland) · PL

Funding

Translational Therapeutics Research Program (TT)P30CA016058 · NCI · OHIO STATE UNIVERSITY · PI Tasleem J Padamsee · 1985 to 2026
$132.3M
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 P30 CA016058NCI NIH HHS R01 CA197870NCI NIH HHS R35 CA197734
6 · The paper itself

Abstract

Acalabrutinib is a selective irreversible Bruton tyrosine kinase (BTK) inhibitor that does not affect IL2-associated tyrosine kinase or antibody-dependent cellular cytotoxicity, making it an attractive candidate for combination therapy with anti-CD20 antibodies. We investigated acalabrutinib plus obinutuzumab in a phase Ib/II study (NCT02296918) of patients with treatment-naïve or relapsed/refractory chronic lymphocytic leukemia (CLL). Nineteen treatment-naïve and 26 relapsed/refractory patients were treated with acalabrutinib (100 mg twice daily) until progression and obinutuzumab (cycle 1: 100 mg day 1, 900 mg day 2, 1000 mg days 8 and 15; cycles 2-6: 1,000 mg day 1). Grade 3/4 adverse events occurred in 71% of patients. Overall response rates were 95% (treatment-naïve) and 92% (relapsed/refractory). Thirty-two percent of treatment-naïve and 8% of relapsed/refractory patients achieved complete remission. At 36 months, 94% (treatment-naïve) and 88% (relapsed/refractory) were progression free. Acalabrutinib plus obinutuzumab was well tolerated, producing high and durable responses in treatment-naïve and relapsed/refractory CLL. SIGNIFICANCE: Rituximab plus the less selective BTK inhibitor ibrutinib has not shown benefit in CLL; however, the selective BTK inhibitor acalabrutinib plus the antibody-dependent cellular cytotoxicity-enhanced antibody obinutuzumab yielded durable responses that deepened over time in treatment-naïve and relapsed/refractory CLL, supporting the evaluation of this approach in larger, comparative studies in CLL.

Indexed as

AdultAgammaglobulinaemia Tyrosine KinaseAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBenzamidesCell ProliferationDrug Administration ScheduleFemaleHumansInterleukin-2Leukemia, Lymphocytic, Chronic, B-CellMaleMiddle AgedPyrazinesRituximabacalabrutinibAgammaglobulinaemia Tyrosine KinaseAntibodies, Monoclonal, HumanizedBenzamidesBTK protein, humanIL2 protein, humanInterleukin-2obinutuzumabPyrazinesRituximab

Identifiers

PMID31915195
PMCPMC8176161
OpenAlexW2999980976

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.