Evidence map›Paper›PMID 25891346›Full record

Trial reportBritish journal of haematology2015

Romidepsin in peripheral and cutaneous T-cell lymphoma: mechanistic implications from clinical and correlative data.

Susan E Bates, Robin Eisch, Alexander Ling, Douglas Rosing, Maria Turner, Stefania Pittaluga, H Miles Prince, Mark H Kirschbaum, Steven L Allen, Jasmine Zain and 15 more

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in British journal of haematology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00007345 (Phase II Trial of Depsipeptide in Patients With Cutaneous T-Cell Lymphoma and Relapsed Peripheral T-Cell Lymphoma), which is not on this map. Cited by 32 papers.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed
–field-weighted citation impact
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.

NCT00007345 phase2completednot on this map

Phase II Trial of Depsipeptide in Patients With Cutaneous T-Cell Lymphoma and Relapsed Peripheral T-Cell Lymphoma

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2001 to 2015Enrolled131ConditionsCutaneous T Cell Lymphoma, Peripheral T Cell LymphomaArmsRomidepsin
3 · Its place in the literature

Who cites it

32 citing papers in PubMed.

  1. Trial
  2. Review
  3. Review
  4. Article
  5. Combined HDAC and eIF4A inhibition: A novel epigenetic therapy for pancreatic ductal adenocarcinoma.Drug resistance updates : reviews and commentaries in antimicrobial and anticancer chemotherapy · 2026
    Article
  6. Review
  7. Article
  8. Article
  9. Epigenetics-targeted drugs: current paradigms and future challenges.Signal transduction and targeted therapy · 2024
    Review
  10. Article
  11. Review
  12. Review
  13. Review
  14. Article
  15. Article
  16. Article
  17. Article
  18. Review
  19. Review
  20. Review
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

25 authors.

Susan E BatesDevelopmental Therapeutics Branch, NCI, NIH, Bethesda, MD, USA.
Robin EischDevelopmental Therapeutics Branch, NCI, NIH, Bethesda, MD, USA.
Alexander LingDepartment of Radiology, Warren G Magnuson Clinical Center, NIH, Bethesda, MD, USA.
Douglas RosingConsultative Cardiology, NHLBI, NIH, Bethesda, MD, USA.
Maria TurnerDermatology Branch, NCI, Bethesda, MD, USA.
Stefania PittalugaLaboratory of Pathology, CCR, NCI, Bethesda, MD, USA.
H Miles PrincePeter MacCallum Cancer Centre, East Melbourne, Vic., Australia.
Mark H KirschbaumHematological Malignancies, Penn State Hershey Medical Center, Hershey, PA, USA.
Steven L AllenHofstra North Shore-LIJ School of Medicine and Monter Cancer Center, Lake Success, NY, USA.
Jasmine ZainColumbia University, New York, NY, USA.
Larisa J GeskinDepartment of Dermatology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
David JoskeSir Charles Gairdner Hospital, Nedlands, WA, Australia.
Leslie PopplewellCity of Hope National Cancer Center, Duarte, CA, USA.
Edward W CowenDermatology Branch, NCI, Bethesda, MD, USA.
Elaine S JaffeLaboratory of Pathology, CCR, NCI, Bethesda, MD, USA.
Jean NicholsCelgene Corporation, Cambridge, MA, USA.
Sally KennedyIndependent Pharmaceutical Consultant, Boston, MA, USA.
Seth M SteinbergBiostatistics and Data Management, NCI, Bethesda, MD, USA.
David J LiewehrBiostatistics and Data Management, NCI, Bethesda, MD, USA.
Louise C ShoweThe Wistar Institute, Philadelphia, PA, USA.
Caryn SteakleyCenter for Cancer Research, NCI, Bethesda, MD, USA.
John WrightCancer Therapy Evaluation Program, DCTDC, NCI, Bethesda, MD, USA.
Tito FojoCenter for Cancer Research, NCI, Bethesda, MD, USA.
Thomas LitmanLEO Pharma A/S, Ballerup, Denmark.
Richard L PiekarzCancer Therapy Evaluation Program, DCTDC, NCI, Bethesda, MD, USA.

Funding

Tumor Microenvironment and MetastasisP30CA010815 · NCI · WISTAR INSTITUTE · PI Luis J Montaner · 1985 to 2026
$75.9M
Phase I Molecular and Clinical Pharmacodynamic Trials ETCTNUM1CA186717 · NCI · BECKMAN RESEARCH INSTITUTE/CITY OF HOPE · PI A. Dimitrios Colevas, Alexey V. Danilov · 2014 to 2026
$19.8M
Lymphoma Disease Discovery and DefintionZIASC000550 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI JAFFE, ELAINE · 2009 to 2025
$16.9M
Hematopathology DiagnosisZIABC011070 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI JAFFE, ELAINE · 2009 to 2025
$14.5M
Dermatology Consultation ServiceZIDBC011317 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI COWEN, EDWARD · 2010 to 2021
$6.4M
Translational Studies of the Histone Deacetylase Inhibitor RomidepsinZIABC010621 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI BATES, SUSAN · 2009 to 2015
$6.2M
HDAC Inhibitors and CTCLR01CA132098 · NCI · WISTAR INSTITUTE · PI SHOWE, LOUISE C. · 2009 to 2013
$2.0M
Intramural NIH HHS ZIA BC010621NCI NIH HHS P30 CA010815NCI NIH HHS R01 CA132098NCI NIH HHS UM1 CA186717
6 · The paper itself

Abstract

Romidepsin is an epigenetic agent approved for the treatment of patients with cutaneous or peripheral T-cell lymphoma (CTCL and PTCL). Here we report data in all patients treated on the National Cancer Institute 1312 trial, demonstrating long-term disease control and the ability to retreat patients relapsing off-therapy. In all, 84 patients with CTCL and 47 with PTCL were enrolled. Responses occurred early, were clinically meaningful and of very long duration in some cases. Notably, patients with PTCL receiving romidepsin as third-line therapy or later had a comparable response rate (32%) of similar duration as the total population (38%). Eight patients had treatment breaks of 3.5 months to 10 years; in four of six patients, re-initiation of treatment led to clear benefit. Safety data show slightly greater haematological and constitutional toxicity in PTCL. cDNA microarray studies show unique individual gene expression profiles, minimal overlap between patients, and both induction and repression of gene expression that reversed within 24 h. These data argue against cell death occurring as a result of an epigenetics-mediated gene induction programme. Together this work supports the safety and activity of romidepsin in T-cell lymphoma, but suggests a complex mechanism of action.

Indexed as

AdultAgedAged, 80 and overAntibiotics, AntineoplasticDepsipeptidesEpigenomicsFemaleHistone Deacetylase InhibitorsHumansLymphoma, T-Cell, CutaneousMaleMiddle AgedProspective StudiesSkin NeoplasmsAntibiotics, AntineoplasticDepsipeptidesHistone Deacetylase Inhibitorsromidepsinchromatinepigenetic therapyhistone deacetylase inhibitorromidepsinT-cell lymphoma

Identifiers

PMID25891346
PMCPMC4675455

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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.