Evidence map›Paper›PMID 26763349›Full record

Trial reportLeukemia & lymphoma2016

Safety and efficacy of different lenalidomide starting doses in patients with relapsed or refractory chronic lymphocytic leukemia: results of an international multicenter double-blinded randomized phase II trial.

Clemens M Wendtner, Michael Hallek, Graeme A M Fraser, Anne-Sophie Michallet, Peter Hillmen, Jan Dürig, Matt Kalaycio, John G Gribben, Stephan Stilgenbauer, Andreas Buhler and 6 more

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

Trial report in Leukemia & lymphoma, 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
3.0field-weighted citation impact, top 9% 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, 19 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Immunomodulatory Drugs for the Treatment of B Cell Malignancies.International journal of molecular sciences · 2021
    Review
  4. Review
  5. Review
  6. New Pharmacotherapies in Chronic Lymphocytic Leukemia.P & T : a peer-reviewed journal for formulary management · 2017
    Article
  7. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 12 institutions in 6 countries.

Clemens M Wendtnera Klinikum Schwabing, Academic Teaching Hospital of University of Munich , Munich , Germany ;
Michael Hallekb Department I of Internal Medicine , University of Cologne , Cologne , Germany ;
Graeme A M Fraserd Juravinski Cancer Centre, McMaster University , Hamilton , Ontario , Canada ;
Anne-Sophie Michallete Hospices Civils De Lyon, Centre Hospitalier Lyon Sud , Pierre Bénite , Lyon , France ;
Peter Hillmenf St James's Institute of Oncology , Leeds , UK ;
Jan Dürigg University Hospital Essen , Essen , Germany ;
Matt Kalaycioh Cleveland Clinic , Cleveland , OH , USA ;
John G Gribbeni Barts Cancer Institute, Queen Mary, University of London , London , UK ;
Stephan Stilgenbauerj Department of Internal Medicine III , Ulm University , Ulm , Germany ;
Andreas Buhlerj Department of Internal Medicine III , Ulm University , Ulm , Germany ;
Thomas J Kippsk University of California San Diego Moores Cancer Center , La Jolla , CA , USA ;
Brendan Pursel Celgene Corporation , Summit , NJ , USA ;
Jennie Zhangl Celgene Corporation , Summit , NJ , USA ;
Sabine De Bedoutm Celgene Corporation , Boudry , Switzerland ;
Jay Meil Celgene Corporation , Summit , NJ , USA ;
Asher Chanan-Khann Mayo Clinic , Jacksonville , FL , USA.
Bristol-Myers Squibb (Switzerland) · CHTechnische Hochschule Ulm · DECleveland Clinic · USEssen University Hospital · DEHôpital Lyon Sud · FRJuravinski Cancer Centre · CALudwig-Maximilians-Universität München · DEQueen Mary University of London · GBSt James's University Hospital · GBUniversity of California, San Diego · USUniversity of Cologne · DEWinnMed · 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

The objective of this study was to evaluate the safety and efficacy of different lenalidomide starting doses in patients with relapsed/refractory chronic lymphocytic leukemia (CLL). CLL patients were randomized to receive lenalidomide at initial doses of 5, 10, or 15 mg/d (N = 103). Doses were escalated by 5 mg every 28-d up to a maximum of 25 mg/d; dose reductions in up to 5 mg decrements were permitted. The most common grade ≥3 adverse events (AEs) were neutropenia and thrombocytopenia. Ten patients died during therapy (four deaths considered as related to lenalidomide); 12 patients experienced second primary malignancies. The most common cause for treatment discontinuation was AEs. Overall response rates were similar across arms. Progression-free survival and overall survival rates were longer in patients who escalated treatment (to 15 or 20 mg/d) versus those who did not. Lower starting doses allowed subsequent dose escalation of lenalidomide while maintaining an acceptable tolerability profile in patients with relapsed/refractory CLL.

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsDrug Resistance, NeoplasmFemaleHumansImmunologic FactorsKaplan-Meier EstimateLenalidomideLeukemia, Lymphocytic, Chronic, B-CellMaleMiddle AgedNeoplasm StagingRecurrenceRetreatmentAntineoplastic AgentsImmunologic FactorsLenalidomideThalidomideClinical trialCLLlenalidomidephase II

Identifiers

PMID26763349
PMCPMC7063681
OpenAlexW2296118977

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.