Evidence map›Paper›PMID 26967821›Full record

Trial reportBlood cancer journal2016

Lenalidomide treatment and prognostic markers in relapsed or refractory chronic lymphocytic leukemia: data from the prospective, multicenter phase-II CLL-009 trial.

A Bühler, C-M Wendtner, T J Kipps, L Rassenti, G A M Fraser, A-S Michallet, P Hillmen, J Dürig, S A Gregory, M Kalaycio and 10 more

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

Trial report in Blood cancer journal, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00963105 (A Phase 2, Multi-Center, Randomized, Double-Blinded, Parallel Group Study of the Safety and Efficacy of Different Lenalidomide), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
2.0field-weighted citation impact, top 14% 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.

NCT00963105 phase2completednot on this map

A Phase 2, Multi-Center, Randomized, Double-Blinded, Parallel Group Study of the Safety and Efficacy of Different Lenalidomide (REVLIMID®) Dose Regimens in Subjects With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia

TypeinterventionalSponsorCelgeneRan2009 to 2017Enrolled104ConditionsRelapsed or Refractory Chronic Lymphocytic LeukemiaArmslenalidomide
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 17 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Review
  5. Review
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  7. Article
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

20 authors at 15 institutions in 7 countries.

A BühlerDepartment of Internal Medicine III, Ulm University, Ulm, Germany.
C-M WendtnerKlinikum Schwabing, Academic Teaching Hospital of University of Munich, Munich, Germany.
T J KippsUniversity of California San Diego Moores Cancer Center, La Jolla, CA, USA.
L RassentiUniversity of California San Diego Moores Cancer Center, La Jolla, CA, USA.
G A M FraserMcMaster University, Juravinski Cancer Centre, Hamilton, ON, Canada.
A-S MichalletHospices civils de Lyon, Centre Hospitalier Lyon Sud, Lyon, France.
P HillmenSt James's Institute of Oncology, Leeds, UK.
J DürigUniversity Hospital Essen, Essen, Germany.
S A GregoryRush University Medical Center, Chicago, IL, USA.
M KalaycioCleveland Clinic, Cleveland, OH, USA.
T Aurran-SchleinitzInstitut Paoli Calmettes, Marseille, France.
L TrentinPadua University School of Medicine, Padua, Italy.
J G GribbenBarts Cancer Institute, Queen Mary, University of London, London, UK.
A Chanan-KhanMayo Clinic, Jacksonville, FL, USA.
B PurseCelgene Corporation, Summit NJ, USA.
J ZhangCelgene Corporation, Summit NJ, USA.
S De BedoutCelgene Corporation, Boudry, Switzerland.
J MeiCelgene Corporation, Summit NJ, USA.
M HallekDepartment I of Internal Medicine, University of Cologne, Cologne, Germany.
S StilgenbauerDepartment of Internal Medicine III, Ulm University, Ulm, Germany.
Universität Ulm · DEUniversity of California, San Diego · USBristol-Myers Squibb (Switzerland) · CHCleveland Clinic · USCologne Excellence Cluster on Cellular Stress Responses in Aging Associated Diseases · DEEssen University Hospital · DEHôpital Lyon Sud · FRInstitut Paoli-Calmettes · FRJuravinski Cancer Centre · CAQueen Mary University of London · GBRush University Medical Center · USSt James's University Hospital · GBUniversity of Cologne · DEUniversity of Padua · ITWinnMed · US

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

Efficacy of lenalidomide was investigated in 103 patients with relapsed/refractory chronic lymphocytic leukemia (CLL) treated on the prospective, multicenter randomized phase-II CLL-009 trial. Interphase cytogenetic and mutational analyses identified TP53 mutations, unmutated IGHV, or del(17p) in 36/96 (37.5%), 68/88 (77.3%) or 22/92 (23.9%) patients. The overall response rate (ORR) was 40.4% (42/104). ORRs were similar irrespective of TP53 mutation (36.1% (13/36) vs 43.3% (26/60) for patients with vs without mutation) or IGHV mutation status (45.0% (9/20) vs 39.1% (27/68)); however, patients with del(17p) had lower ORRs than those without del(17p) (21.7% (5/22) vs 47.1% (33/70); P=0.049). No significant differences in progression-free survival and overall survival (OS) were observed when comparing subgroups defined by the presence or absence of high-risk genetic characteristics. In multivariate analyses, only multiple prior therapies (⩾3 lines) significantly impacted outcomes (median OS: 21.2 months vs not reached; P=0.019). This analysis indicates that lenalidomide is active in patients with relapsed/refractory CLL with unfavorable genetic profiles, including TP53 inactivation or unmutated IGHV. (ClinicalTrials.gov identifier: NCT00963105).

Indexed as

Drug Resistance, NeoplasmAgedAged, 80 and overAntineoplastic AgentsFemaleFollow-Up StudiesHumansImmunoglobulin Heavy ChainsImmunologic FactorsLenalidomideLeukemia, Lymphocytic, Chronic, B-CellMaleMiddle AgedMutationPrognosisRecurrenceAntineoplastic AgentsImmunoglobulin Heavy ChainsImmunologic FactorsLenalidomideThalidomideTumor Suppressor Protein p53

Identifiers

PMID26967821
PMCPMC4817104
OpenAlexW2294823670

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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.