Evidence map›Paper›PMID 25797560›Full record

Trial reportLeukemia & lymphoma2015

A phase 2 study of the BH3 mimetic BCL2 inhibitor navitoclax (ABT-263) with or without rituximab, in previously untreated B-cell chronic lymphocytic leukemia.

Thomas J Kipps, Herbert Eradat, Sebastian Grosicki, John Catalano, Walter Cosolo, Iryna S Dyagil, Sreeni Yalamanchili, Akiko Chai, Srikumar Sahasranaman, Elizabeth Punnoose and 2 more

Abstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Leukemia & lymphoma, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 115 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
115citing papers in PubMed, 1 pooled it
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

115 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  5. Article
  6. Targeting BCL-xL in Myeloid Malignancies: From Inhibitors to PROTAC.Journal of cellular and molecular medicine · 2026
    Review
  7. BCL-2 and BCL-xL in Cancer: Regulation, Function, and Therapeutic Targeting.International journal of molecular sciences · 2026
    Review
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  10. Review
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  19. BCL-XScience advances · 2024
    Article
  20. Review

55 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

12 authors.

Thomas J Kippsa Department of Hematology-Oncology , UCSD School of Medicine , San Diego , CA , USA.
Herbert Eradatb Division of Hematology-Oncology, David Geffen School of Medicine at UCLA , Los Angeles , CA , USA.
Sebastian Grosickic Department of Hematology , Community Hospitals , Chorzow , Poland.
John Catalanod Frankston Hospital and Monash University , Frankston , Australia.
Walter Cosoloe John Fawkner Cancer Trial Centre , Coburg , Australia.
Iryna S Dyagilf Department of Hematology , National Research Center for Radiation Medicine of National Medical Academy of Sciences of Ukraine , Kyiv , Ukraine.
Sreeni Yalamanchilig Genentech, Inc. , South San Francisco , CA , USA.
Akiko Chaig Genentech, Inc. , South San Francisco , CA , USA.
Srikumar Sahasranamang Genentech, Inc. , South San Francisco , CA , USA.
Elizabeth Punnooseg Genentech, Inc. , South San Francisco , CA , USA.
Deborah Hurstg Genentech, Inc. , South San Francisco , CA , USA.
Halyna Pylypenkoh Department of Hematology , Cherkassy Regional Oncological Center , Cherkassy , Ukraine.

Funding

Tissue CoreP01CA081534 · NCI · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI KIPPS, THOMAS J · 2000 to 2016
$59.5M
NCI NIH HHS P01 CA081534
6 · The paper itself

Abstract

We evaluated the safety and biologic activity of the BH3 mimetic protein, navitoclax, combined with rituximab, in comparison to rituximab alone. One hundred and eighteen patients with chronic lymphocytic leukemia (CLL) were randomized to receive eight weekly doses of rituximab (arm A), eight weekly doses of rituximab plus daily navitoclax for 12 weeks (arm B) or eight weekly doses of rituximab plus daily navitoclax until disease progression or unacceptable toxicity (arm C). Investigator-assessed overall response rates (complete [CR] and partial [PR]) were 35% (arm A), 55% (arm B, p = 0.19 vs. A) and 70% (arm C, p = 0.0034 vs. A). Patients with del(17p) or high levels of BCL2 had significantly better clinical responses when treated with navitoclax. Navitoclax in combination with rituximab was well tolerated as initial therapy for patients with CLL, yielded higher response rates than rituximab alone and resulted in prolonged progression-free survival with treatment beyond 12 weeks.

Indexed as

AdultAgedAged, 80 and overAniline CompoundsAntineoplastic Combined Chemotherapy ProtocolsBiomarkersFemaleHumansKaplan-Meier EstimateLeukemia, Lymphocytic, Chronic, B-CellMaleMiddle AgedProto-Oncogene Proteins c-bcl-2RituximabSulfonamidesTreatment OutcomeAniline CompoundsBiomarkersnavitoclaxProto-Oncogene Proteins c-bcl-2RituximabSulfonamidesABT-263B-cellBCL2BH3chronic lymphocytic leukemiaclinical trialnavitoclaxrituximab

Identifiers

PMID25797560
PMCPMC4643417

What OpenQuestion holds

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Registered trials

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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.