Evidence map›Paper›PMID 21355097›Full record

Trial reportBlood2011

Phase 2 trial of romidepsin in patients with peripheral T-cell lymphoma.

Richard L Piekarz, Robin Frye, H Miles Prince, Mark H Kirschbaum, Jasmine Zain, Steven L Allen, Elaine S Jaffe, Alexander Ling, Maria Turner, Cody J Peer and 10 more

2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Blood, 2011. 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 209 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
209citing papers in PubMed, 3 pooled it
22.4field-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.

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
NCT03964480 recruitingnot on this mapstarted 2018, after this paper: background citation

Prospective Observational International Registry of Patients With Newly Diagnosed Peripheral T Cell Lymphoma.

Typeobservational_patient_registrySponsorAssociazione Angela Serra per la ricerca sul cancroRan2018 to 2025Enrolled1,000ConditionsPeripheral T-Cell Lymphoma
3 · Its place in the literature

Who cites it

209 citing papers in PubMed, 3 syntheses or guidelines pooled it, 484 citations in OpenAlex.

  1. Pooled it
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  8. Phase II Intergroup Trial of Alisertib in Relapsed and Refractory Peripheral T-Cell Lymphoma and Transformed Mycosis Fungoides: SWOG 1108.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2015
    Trial
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149 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors at 11 institutions in 2 countries.

Richard L PiekarzCancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health/DHHS, 6130 Executive Blvd., Rockville, MD 20852, USA. rpiekarz@nih.gov
Robin Frye
H Miles Prince
Mark H Kirschbaum
Jasmine Zain
Steven L Allen
Elaine S Jaffe
Alexander Ling
Maria Turner
Cody J Peer
William D Figg
Seth M Steinberg
Sonali Smith
David Joske
Ian Lewis
Laura Hutchins
Michael Craig
A Tito Fojo
John J Wright
Susan E Bates
Center for Cancer Research · USNational Cancer Institute · USCity Of Hope National Medical Center · USNational Cancer Center · USNational Institutes of Health Clinical Center · USPeter MacCallum Cancer Centre · AURoyal Adelaide Hospital · AUSir Charles Gairdner Hospital · AUUniversity of Arkansas for Medical Sciences · USUniversity of Chicago · USWest Virginia University · US

Funding

Sample Processing and Analytical Methods Development for New Anticancer AgentsZICSC006536 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI FIGG, WILLIAM DOUGLAS · 2009 to 2025
$18.1M
Lymphoma Disease Discovery and DefintionZIASC000550 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI JAFFE, ELAINE · 2009 to 2025
$16.9M
Office of Collaborative BiostatisticsZIDSC007202 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI CHOO-WOSOBA, HYOYOUNG · 2009 to 2025
$14.5M
Hematopathology DiagnosisZIABC011070 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI JAFFE, ELAINE · 2009 to 2025
$14.5M
Using Clinical Pharmacology Principles to Develop New Anticancer TherapiesZICSC006537 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI FIGG, WILLIAM DOUGLAS · 2009 to 2025
$14.4M
Translational Studies of the Histone Deacetylase Inhibitor RomidepsinZIABC010621 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI BATES, SUSAN · 2009 to 2015
$6.2M
Pharmacokinetic and Pharmacodynamic Modeling of Anticancer AgentsZICBC010548 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI FIGG, WILLIAM DOUGLAS · 2009 to 2018
$5.9M
Multidrug Resistance Mediated by P-glycoproteinZIASC006732 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI FOJO, ANTONIO · 2009 to 2015
$3.3M
Intramural NIH HHS
6 · The paper itself

Abstract

Romidepsin (depsipeptide or FK228) is a histone deacetylase inhibitor, one of a new class of agents active in T-cell lymphoma. A phase 2 trial was conducted in cutaneous (CTCL) and peripheral (PTCL) T-cell lymphoma. Major and durable responses in CTCL supported the approval of romidepsin for CTCL. Forty-seven patients with PTCL of various subtypes including PTCL NOS, angioimmunoblastic, ALK-negative anaplastic large cell lymphoma, and enteropathy-associated T-cell lymphoma were enrolled. All patients had received prior therapy with a median of 3 previous treatments (range 1-11); 18 (38%) had undergone stem-cell transplant. All patients were evaluated for toxicity; 2 patients discovered to be ineligible were excluded from response assessment. Common toxicities were nausea, fatigue, and transient thrombocytopenia and granulocytopenia. Complete responses were observed in 8 and partial responses in 9 of 45 patients, for an overall response rate of 38% (95% confidence interval 24%-53%). The median duration of overall response was 8.9 months (range 2-74). Responses were observed in various subtypes, with 6 responses among the 18 patients with prior stem-cell transplant. The histone deacetylase inhibitor romidepsin has single agent clinical activity associated with durable responses in patients with relapsed PTCL.

Indexed as

AdultAgedAged, 80 and overAntibiotics, AntineoplasticDepsipeptidesDisease ProgressionFemaleHumansLymphoma, Large-Cell, AnaplasticLymphoma, T-Cell, CutaneousLymphoma, T-Cell, PeripheralMaleMiddle AgedRemission InductionSkin NeoplasmsSurvival RateAntibiotics, AntineoplasticDepsipeptidesromidepsin

Identifiers

PMID21355097
PMCPMC3112033
OpenAlexW2080029028

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.