Evidence map›Paper›PMID 27389174›Full record

Trial reportLeukemia & lymphoma2017

Associations of ofatumumab exposure and treatment outcomes in patients with untreated CLL receiving chemoimmunotherapy.

Roxanne C Jewell, Thomas J Kipps, Jan Dürig, Laimonas Griskevicius, Stephan Stilgenbauer, Lukáš Smolej, Jiří Mayer, Georg Hess, Francisco J Hernandez-Ilizaliturri, Swaminathan Padmanabhan-Iyer and 7 more

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Leukemia & lymphoma, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00410163 (An Open-labeled, Randomized, Two-dose, Parallel Group Trial of Ofatumumab, a Fully Human Monoclonal Anti-CD20 Antibody, in Combination With Fludarabine and Cyclophosphamide, in Patients With Previously Untreated B-cell CLL), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

NCT00410163 phase2completednot on this map

An Open-labeled, Randomized, Two-dose, Parallel Group Trial of Ofatumumab, a Fully Human Monoclonal Anti-CD20 Antibody, in Combination With Fludarabine and Cyclophosphamide, in Patients With Previously Untreated B-cell CLL

TypeinterventionalSponsorGlaxoSmithKlineRan2007 to 2013Enrolled61ConditionsLeukaemia, Lymphocytic, ChronicArmsOfatumumab 500mg, Ofatumumab 1000mg, Fludarabine, Cyclophosphamide
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

17 authors.

Roxanne C Jewella Novartis Pharmaceuticals , Morrisville , NC , USA.
Thomas J Kippsb UCSD Moores Cancer Center , La Jolla , CA , USA.
Jan Dürigc Klinik für Hämatologie , Universitätsklinikum Essen , Essen , Germany.
Laimonas Griskeviciusd Vilnius University Hospital Santariskiu Klinikos, Vilnius University , Vilnius , Lithuania.
Stephan Stilgenbauere Department of Internal Medicine III , Universitätsklinikum Ulm , Ulm , Germany.
Lukáš Smolejf 4th Department of Internal Medicine - Hematology , University Hospital and Faculty of Medicine , Hradec Králové , Czech Republic.
Jiří Mayerg Department of Internal Medicine/Hemato-Oncology , University Hospital Brno , Brno , Czech Republic.
Georg Hessh Johannes Gutenberg University , Mainz , Germany.
Francisco J Hernandez-Ilizaliturrii Roswell Park Cancer Institute , Buffalo , NY , USA.
Swaminathan Padmanabhan-Iyerj Cancer Therapy and Research Center , San Antonio , TX , USA.
Lei Fangk Pharstat Inc. , Raleigh , NC , USA.
Nancy Goldsteina Novartis Pharmaceuticals , Morrisville , NC , USA.
Michele Gorczycal GlaxoSmithKline , Collegeville , PA , USA.
Ira Guptam Novartis Pharmaceuticals , King of Prussia , PA , USA.
Steen Lisbyn Genmab , Copenhagen , Denmark.
William G Wierdao MD Anderson Cancer Center, The University of Texas , Houston , TX , USA.
Hx-CD20-407 Study Investigators

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

Relationships between patient characteristics, ofatumumab pharmacokinetics, and treatment outcomes were investigated in this phase 2 trial of ofatumumab plus fludarabine and cyclophosphamide (FC) in untreated chronic lymphocytic leukemia. Patients were randomized 1:1 to receive 500 or 1000 mg ofatumumab (Cycle 1; 300 mg) plus FC every 4 weeks for six cycles. Median C

trial registrationwww.clinicaltrials.gov (NCT00410163).

Indexed as

AdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalAntineoplastic Combined Chemotherapy ProtocolsChromosome AberrationsDrug Administration ScheduleFemaleHumansLeukemia, Lymphocytic, Chronic, B-CellMaleMiddle AgedNeoplasm MetastasisNeoplasm StagingRemission InductionAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalofatumumabChemoimmunotherapychronic lymphocytic leukemiaofatumumabpharmacokinetics

Identifiers

PMID27389174
PMCPMC7053426

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.