Evidence map›Paper›PMID 24030098›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2013

Long-term follow-up of lenalidomide in relapsed/refractory mantle cell lymphoma: subset analysis of the NHL-003 study.

P L Zinzani, J M Vose, M S Czuczman, C B Reeder, C Haioun, J Polikoff, H Tilly, L Zhang, K Prandi, J Li and 1 more

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

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 53 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 2 pooled it
11.3field-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.

NCT00413036 phase2completednot on this map

A Phase II, Multicenter, Single-Arm, Open-Label Study To Evaluate The Safety And Efficacy Of Single-Agent Lenalidomide (Revlimid®, CC-5013) in Subjects With Relapsed Or Refractory Aggressive Non-Hodgkin's Lymphoma

TypeinterventionalSponsorCelgeneRan2006 to 2011Enrolled217ConditionsLymphoma, Non-Hodgkin'sArmslenalidomide
NCT02446236 phase1active not recruitingnot on this mapstarted 2015, after this paper: background citation

Phase Ib Dose Finding Study of Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib (PCI-32765) Plus Lenalidomide / Rituximab in Relapsed or Refractory Mantle Cell Lymphoma (MCL)

TypeinterventionalSponsorHackensack Meridian HealthRan2015 to 2026Enrolled27ConditionsMantle Cell LymphomaArmsLenalidomide, Ibrutinib, Rituximab
3 · Its place in the literature

Who cites it

53 citing papers in PubMed, 2 syntheses or guidelines pooled it, 120 citations in OpenAlex.

  1. Pooled it
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  16. Article
  17. Sequencing of Novel Therapies for Mantle Cell Lymphoma.Current treatment options in oncology · 2021
    Review
  18. Non-chemotherapy Options for Newly Diagnosed Mantle Cell Lymphoma.Current treatment options in oncology · 2021
    Review
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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

11 authors at 7 institutions in 3 countries.

P L ZinzaniInstitute of Hematology 'Seràgnoli', University of Bologna, Bologna, Italy.
J M Vose
M S Czuczman
C B Reeder
C Haioun
J Polikoff
H Tilly
L Zhang
K Prandi
J Li
T E Witzig
Centre Virchow-Villermé · FRKaiser Permanente · USMayo Clinic in Arizona · USNebraska Medical Center · USRoswell Park Comprehensive Cancer Center · USUniversity of Bologna · ITWinnMed · US

Funding

Women's Cancer ProgramP30CA015083 · NCI · MAYO CLINIC ROCHESTER · PI Felicity Enders · 1985 to 2026
$151.3M
NCI NIH HHS P30 CA015083
6 · The paper itself

Abstract

backgroundMantle cell lymphoma (MCL) is an uncommon type of non-Hodgkin lymphoma with poor overall prognosis, requiring the development of new therapies. Lenalidomide is an immunomodulatory agent demonstrating antitumor and antiproliferative effects in MCL. We report results from a long-term subset analysis of 57 patients with relapsed/refractory MCL from the NHL-003 phase II multicenter study of single-agent lenalidomide in patients with aggressive lymphoma

designLenalidomide was administered orally 25 mg daily on days 1-21 every 28 days until progressive disease (PD) or intolerability. The primary end point was overall response rate (ORR).

resultsFifty-seven patients with relapsed/refractory, advanced-stage MCL had a median of three prior therapies. The ORR was 35% [complete response (CR)/CR unconfirmed (CRu) 12%], with a median duration of response (DOR) of 16.3 months (not yet reached in patients with CR/CRu) by blinded independent central review. The median time to first response was 1.9 months. Median progression-free survival was 8.8 months, and overall survival had not yet been reached. The most common grade 3/4 adverse events (AEs) were neutropenia (46%), thrombocytopenia (30%), and anemia (13%).

conclusionsThese results show the activity of lenalidomide in heavily pretreated, relapsed/refractory MCL. Responders had a durable response with manageable side-effects. Clinical trial number posted on www.clinicaltrials.gov NCT00413036.

Indexed as

AdultAgedAged, 80 and overDisease-Free SurvivalDrug Administration ScheduleDrug-Related Side Effects and Adverse ReactionsFemaleFollow-Up StudiesHumansKaplan-Meier EstimateLenalidomideLymphoma, Mantle-CellMaleMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingLenalidomideThalidomidelenalidomidemantle cell lymphomanon-Hodgkin lymphoma

Identifiers

PMID24030098
PMCPMC3811905
OpenAlexW2111611512

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.