Evidence map›Paper›PMID 29305552›Full record

Trial reportBlood2018

Venetoclax for patients with chronic lymphocytic leukemia who progressed during or after idelalisib therapy.

Steven Coutre, Michael Choi, Richard R Furman, Herbert Eradat, Leonard Heffner, Jeffrey A Jones, Brenda Chyla, Lang Zhou, Suresh Agarwal, Tina Waskiewicz and 5 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Blood, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02141282 (A Phase 2 Open-Label Study of the Efficacy and Safety of ABT-199), which is not on this map. Cited by 66 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
66citing papers in PubMed, 3 pooled it
14.0field-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.

NCT02141282 phase2completednot on this map

A Phase 2 Open-Label Study of the Efficacy and Safety of ABT-199 (GDC-0199) in Chronic Lymphocytic Leukemia Subjects With Relapse or Refractory to B-Cell Receptor Signaling Pathway Inhibitor Therapy

TypeinterventionalSponsorAbbVieRan2014 to 2021Enrolled127ConditionsChronic Lymphocytic LeukemiaArmsVenetoclax
3 · Its place in the literature

Who cites it

66 citing papers in PubMed, 3 syntheses or guidelines pooled it, 131 citations in OpenAlex.

  1. Pooled it
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  7. Biotransformation and disposition of CCancer chemotherapy and pharmacology · 2025
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  14. Landscape ofInternational journal of molecular sciences · 2023
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6 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 9 institutions in 1 country.

Steven CoutreStanford Cancer Center, Stanford University School of Medicine, Stanford, CA.
Michael ChoiMoores Cancer Center, University of California San Diego, San Diego, CA.
Richard R FurmanWeill Cornell Medicine, New York, NY.
Herbert EradatDivision of Hematology-Oncology, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA.
Leonard HeffnerEmory University School of Medicine, Atlanta, GA.
Jeffrey A JonesDivision of Hematology, The Ohio State University, Columbus, OH.
Brenda ChylaAbbVie Inc., North Chicago, IL.
Lang ZhouAbbVie Inc., North Chicago, IL.
Suresh AgarwalAbbVie Inc., North Chicago, IL.
Tina WaskiewiczAbbVie Inc., North Chicago, IL.
Maria VerdugoAbbVie Inc., North Chicago, IL.
Rod A HumerickhouseAbbVie Inc., North Chicago, IL.
Jalaja PotluriAbbVie Inc., North Chicago, IL.
William G WierdaUniversity of Texas MD Anderson Cancer Center, Houston, TX; and.
Matthew S DavidsDana-Farber Cancer Institute, Boston, MA.
AbbVie (United States) · USCornell University · USDana-Farber Cancer Institute · USEmory University · USStanford University · USThe Ohio State University · USThe University of Texas MD Anderson Cancer Center · USUniversity of California, Los Angeles · USUniversity of California, San Diego · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

B-cell receptor pathway inhibitors (BCRis) have transformed treatment of chronic lymphocytic leukemia (CLL); however, the efficacy of therapies for patients whose disease is refractory to/relapses after (R/R) BCRis is unknown. Venetoclax is a selective, orally bioavailable BCL-2 inhibitor with activity in patients with CLL, including those who are heavily pretreated or have 17p deletion. This phase 2 study prospectively evaluated venetoclax in patients with R/R CLL after ibrutinib or idelalisib; here we report on patients who received idelalisib as the last BCRi before enrollment. Venetoclax was initiated at 20 mg daily, followed by intrapatient ramp-up to 400 mg daily. Primary objectives included efficacy (objective response rate [ORR]) and safety of venetoclax. The study enrolled 36 patients who previously received idelalisib (ORR, 67% [24/36]); 2 patients achieved complete remission, and 1 had complete remission with incomplete bone marrow recovery. Median progression-free survival (PFS) has not yet been reached; estimated 12-month PFS was 79%. The most common adverse events (AEs; all grades) were neutropenia (56%), diarrhea (42%), upper respiratory tract infection (39%), thrombocytopenia (36%), nausea (31%), fatigue (28%), cough (22%), rash (22%), and anemia (22%). Grade 3 or 4 AEs were primarily hematologic (neutropenia [50%], thrombocytopenia [25%], and anemia [17%]). No patients experienced tumor lysis syndrome. Venetoclax demonstrated promising clinical activity and favorable tolerability in patients with CLL whose disease progressed during or after idelalisib therapy. This trial was registered at www.clinicaltrials.gov as #NCT02141282.

Indexed as

Administration, OralAgedAged, 80 and overBridged Bicyclo Compounds, HeterocyclicDisease-Free SurvivalFemaleHumansLeukemia, Lymphocytic, Chronic, B-CellMaleMiddle AgedProto-Oncogene Proteins c-bcl-2PurinesQuinazolinonesRecurrenceSulfonamidesSurvival RateBCL2 protein, humanBridged Bicyclo Compounds, HeterocyclicidelalisibProto-Oncogene Proteins c-bcl-2PurinesQuinazolinonesSulfonamidesvenetoclax

Identifiers

PMID29305552
PMCPMC5922273
OpenAlexW2781558580

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.