Evidence map›Paper›PMID 23065525›Full record

Trial reportHaematologica2013

Multicenter phase II study of plitidepsin in patients with relapsed/refractory non-Hodgkin's lymphoma.

Vincent Ribrag, Dolores Caballero, Christophe Fermé, Emanuele Zucca, Reyes Arranz, Javier Briones, Christian Gisselbrecht, Gilles Salles, Alessandro M Gianni, Henry Gomez and 7 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Haematologica, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00884286 (A Phase II Multicenter, Open-Label, Clinical And Pharmacokinetic Study of Aplidin® As A 1-Hour Weekly IV Infusion, in Patients With Relapsed Or Refractory Aggressive Non-Hodgkin's Lymphoma), which is not on this map. Cited by 25 papers.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed
4.4field-weighted citation impact, top 6% 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.

NCT00884286 phase2completednot on this map

A Phase II Multicenter, Open-Label, Clinical And Pharmacokinetic Study of Aplidin® As A 1-Hour Weekly IV Infusion, in Patients With Relapsed Or Refractory Aggressive Non-Hodgkin's Lymphoma

TypeinterventionalSponsorPharmaMarRan2004 to 2010Enrolled67ConditionsLeukemia, LymphomaArmsAplidin®
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 59 citations in OpenAlex.

  1. Aplidin in patients with advanced dedifferentiated liposarcomas: a French Sarcoma Group Single-Arm Phase II study.Annals of oncology : official journal of the European Society for Medical Oncology · 2015
    Trial
  2. Trial
  3. Review
  4. EEF1A2 identified as a hub gene associated with the severity of metabolic dysfunction-associated steatotic liver disease.Mammalian genome : official journal of the International Mammalian Genome Society · 2025
    Article
  5. Review
  6. Review
  7. Review
  8. Review
  9. Article
  10. Article
  11. Review
  12. Enriching cancer pharmacology with drugs of marine origin.British journal of pharmacology · 2020
    Review
  13. Article
  14. Review
  15. Review
  16. Pharmacokinetics and excretion ofInvestigational new drugs · 2017
    Article
  17. Review
  18. Plitidepsin: design, development, and potential place in therapy.Drug design, development and therapy · 2017
    Review
  19. Review
  20. 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

17 authors at 10 institutions in 5 countries.

Vincent RibragInstitut de Cancérologie Gustave Roussy, Villejuif, France. ribrag@igr.fr
Dolores Caballero
Christophe Fermé
Emanuele Zucca
Reyes Arranz
Javier Briones
Christian Gisselbrecht
Gilles Salles
Alessandro M Gianni
Henry Gomez
Carmen Kahatt
Claudia Corrado
Sergio Szyldergemajn
Sonia Extremera
Bernardo de Miguel
Martin Cullell-Young
Franco Cavalli
PharmaMar (Spain) · ESInstitut Gustave Roussy · FROspedale San Giovanni Bellinzona · CHComplejo Hospitalario de Salamanca · ESHospices Civils de Lyon · FRHospital Universitario de La Princesa · ESInstituto Nacional de Enfermedades Neoplásicas · PEIstituti di Ricovero e Cura a Carattere Scientifico · ITUniversitat Autònoma de Barcelona · ESUniversité Paris Cité · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This phase II clinical trial evaluated the efficacy, safety and pharmacokinetics of plitidepsin 3.2 mg/m(2) administered as a 1-hour intravenous infusion weekly on days 1, 8 and 15 every 4 weeks in 67 adult patients with relapsed/refractory aggressive non-Hodgkin's lymphoma. Patients were divided into two cohorts: those with non-cutaneous peripheral T-cell lymphoma (n=34) and those with other lymphomas (n=33). Efficacy was evaluated using the International Working Group criteria (1999). Of the 29 evaluable patients with non-cutaneous peripheral T-cell lymphoma, six had a response (overall response rate 20.7%; 95% confidence interval, 8.0%-39.7%), including two complete responses and four partial responses. No responses occurred in the 30 evaluable patients with other lymphomas (including 27 B-cell lymphomas). The most common plitidepsin-related adverse events were nausea, fatigue and myalgia (grade 3 in <10% of cases). Severe laboratory abnormalities (lymphopenia, anemia, thrombocytopenia, and increased levels of transaminase and creatine phosphokinase) were transient and easily managed by plitidepsin dose adjustments. The pharmacokinetic profile did not differ from that previously reported in patients with solid tumors. In conclusion, plitidepsin monotherapy has clinical activity in relapsed/refractory T-cell lymphomas. Combinations of plitidepsin with other chemotherapeutic drugs deserve further evaluation in patients with non-cutaneous peripheral T-cell lymphoma. (clinicaltrials.gov identifier: NCT00884286).

Indexed as

AdolescentAdultAgedAged, 80 and overAntineoplastic AgentsDepsipeptidesFemaleHumansLymphoma, Non-HodgkinMaleMiddle AgedNeoplasm GradingNeoplasm StagingPeptides, CyclicRecurrenceTreatment OutcomeAntineoplastic AgentsDepsipeptidesPeptides, Cyclicplitidepsin

Identifiers

PMID23065525
PMCPMC3659946
OpenAlexW1993685031

What OpenQuestion holds

Textmetadata
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.