Evidence map›Paper›PMID 29096668›Full record

Observational studyJournal of hematology & oncology2017

Observational study of lenalidomide in patients with mantle cell lymphoma who relapsed/progressed after or were refractory/intolerant to ibrutinib (MCL-004).

Michael Wang, Stephen J Schuster, Tycel Phillips, Izidore S Lossos, Andre Goy, Simon Rule, Mehdi Hamadani, Nilanjan Ghosh, Craig B Reeder, Evelyn Barnett and 2 more

2 registry-linked trialsOpen access · goldAbstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Journal of hematology & oncology, 2017. 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 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed
3.2field-weighted citation impact, top 7% 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.

NCT02341781 completednot on this map

A Multicenter, Observational Study to Evaluate the Effectiveness of Lenalidomide (Revlimid®) in Subjects With Mantle Cell Lymphoma Who Have Relapsed or Progressed After Treatment With Ibrutinib or Are Refractory or Intolerant to Ibrutinib.

TypeobservationalSponsorCelgeneRan2015 to 2016Enrolled30ConditionsLymphoma, Mantle-Cell
NCT02601313 phase2completednot on this map

A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-X19 in Subjects With Relapsed/Refractory Mantle Cell Lymphoma

TypeinterventionalSponsorKite, A Gilead CompanyRan2015 to 2023Enrolled105ConditionsRelapsed/Refractory Mantle Cell LymphomaArmsbrexucabtagene autoleucel, Cyclophosphamide, Fludarabine, Axicabtagene Ciloleucel
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 60 citations in OpenAlex.

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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

12 authors at 11 institutions in 3 countries.

Michael WangDepartment of Lymphoma/Myeloma, University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, TX, USA. miwang@mdanderson.org.
Stephen J SchusterAbramson Cancer Center of the University of Pennsylvania, Philadelphia, PA, USA.
Tycel PhillipsUniversity of Michigan, Ann Arbor, MI, USA.
Izidore S LossosSylvester Comprehensive Cancer Center, Division of Hematology Oncology, University of Miami, Miami, FL, USA.
Andre GoyJohn Theurer Cancer Center at HUMC, Hackensack, NJ, USA.
Simon RuleDepartment of Haematology, Derriford Hospital and Plymouth University Medical School, Plymouth, UK.
Mehdi HamadaniMedical College of Wisconsin & CIBMTR, Milwaukee, WI, USA.
Nilanjan GhoshCarolinas HealthCare System, Levine Cancer Institute, Charlotte, NC, USA.
Craig B ReederMayo Clinic Scottsdale/Phoenix, Scottsdale, AZ, USA.
Evelyn BarnettCelgene Corporation, Summit, NJ, USA.
Marie-Laure Casadebaig BravoCelgene International Sàrl, Boudry, Switzerland.
Peter MartinWeill Cornell Medical College, New York, NY, USA.
Bristol-Myers Squibb (Switzerland) · CHCornell University · USDerriford Hospital · GBHackensack University Medical Center · USLevine Cancer Institute · USMayo Clinic in Arizona · USMedical College of Wisconsin · USThe University of Texas MD Anderson Cancer Center · USUniversity of Miami · USUniversity of Michigan–Ann Arbor · USUniversity of Pennsylvania · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe observational MCL-004 study evaluated outcomes in patients with relapsed/refractory mantle cell lymphoma who received lenalidomide-based therapy after ibrutinib failure or intolerance.

methodsThe primary endpoint was investigator-assessed overall response rate based on the 2007 International Working Group criteria.

resultsOf 58 enrolled patients (median age, 71 years; range, 50-89), 13 received lenalidomide monotherapy, 11 lenalidomide plus rituximab, and 34 lenalidomide plus other treatment. Most patients (88%) had received ≥ 3 prior therapies (median 4; range, 1-13). Median time from last dose of ibrutinib to the start of lenalidomide was 1.3 weeks (range, 0.1-21.7); 45% of patients had partial responses or better to prior ibrutinib. Primary reasons for ibrutinib discontinuation were lack of efficacy (88%) and ibrutinib toxicity (9%). After a median of two cycles (range, 0-11) of lenalidomide-based treatment, 17 patients responded (8 complete responses, 9 partial responses), for a 29% overall response rate (95% confidence interval, 18-43%) and a median duration of response of 20 weeks (95% confidence interval, 2.9 to not available). Overall response rate to lenalidomide-based therapy was similar for patients with relapsed/progressive disease after previous response to ibrutinib (i.e., ≥PR) versus ibrutinib-refractory (i.e., ≤SD) patients (30 versus 32%, respectively). The most common all-grade treatment-emergent adverse events after lenalidomide-containing therapy (n = 58) were fatigue (38%) and cough, dizziness, dyspnea, nausea, and peripheral edema (19% each). At data cutoff, 28 patients have died, primarily due to mantle cell lymphoma.

conclusionLenalidomide-based treatment showed clinical activity, with no unexpected toxicities, in patients with relapsed/refractory mantle cell lymphoma who previously failed ibrutinib therapy.

trial registrationClinicaltrials.gov identifier NCT02341781 . Date of registration: January 14, 2015.

Indexed as

AdenineAgedAged, 80 and overDisease ProgressionFemaleHumansLenalidomideLymphoma, Mantle-CellMaleMiddle AgedPiperidinesPyrazolesPyrimidinesRecurrenceThalidomideAdenineibrutinibLenalidomidePiperidinesPyrazolesPyrimidinesThalidomideIbrutinib failureLenalidomideMantle cell lymphoma

Identifiers

PMID29096668
PMCPMC5668956
OpenAlexW2766065657

What OpenQuestion holds

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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.