Evidence map›Paper›PMID 19874311›Full record

Trial reportBritish journal of haematology2010

Laboratory correlates for a phase II trial of romidepsin in cutaneous and peripheral T-cell lymphoma.

Susan E Bates, Zhirong Zhan, Kenneth Steadman, Tomasz Obrzut, Victoria Luchenko, Robin Frye, Robert W Robey, Maria Turner, Erin R Gardner, William D Figg and 5 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase II
In one paragraph

Trial report in British journal of haematology, 2010. 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 38 papers.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed
3.8field-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.

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

38 citing papers in PubMed, 77 citations in OpenAlex.

  1. Trial
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  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
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  18. Therapeutic Options for Aggressive T-Cell Lymphomas.Current hematologic malignancy reports · 2017
    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

15 authors at 3 institutions in 1 country.

Susan E BatesMedical Oncology Branch, National Institutes of Health, Bethesda, MD 20892, USA. sebates@helix.nih.gov
Zhirong Zhan
Kenneth Steadman
Tomasz Obrzut
Victoria Luchenko
Robin Frye
Robert W Robey
Maria Turner
Erin R Gardner
William D Figg
Seth M Steinberg
Alex Ling
Tito Fojo
Kin Wah To
Richard L Piekarz
National Institutes of Health · USNational Institutes of Health Clinical Center · USScience Applications International Corporation (United States) · 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
Office of Collaborative BiostatisticsZIDSC007202 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI CHOO-WOSOBA, HYOYOUNG · 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
Intramural NIH HHS Z99 CA999999NCI NIH HHS N01 CO012400NCI NIH HHS N01-CO-12400
6 · The paper itself

Abstract

Romidepsin has shown promise in the treatment of T-cell lymphomas, and so we evaluated molecular endpoints gathered from 61 patients enrolled on a phase II trial of romidepsin in cutaneous and peripheral T-cell lymphoma at the National Institutes of Health. The endpoints included histone H3 acetylation and ABCB1 gene expression in peripheral blood mononuclear cells (PBMCs); ABCB1 gene expression in tumour biopsy samples; and blood fetal haemoglobin levels (HbF), all of which were increased following romidepsin treatment. The fold increase in histone acetylation in PBMCs at 24 h was weakly to moderately well correlated with the pharmacokinetic parameters C(max) and area under the curve (AUC)(last) (rho = 0.37, P = 0.03 and rho = 0.36, P = 0.03 respectively) and inversely associated with clearance (rho = -0.44; P = 0.03). Histone acetylation in PBMCs at 24 h was associated with response (P = 0.026) as was the increase in fetal haemoglobin (P = 0.014); this latter association may be due to the longer on-study duration for patients with disease response. Together, these results suggest that pharmacokinetics may be an important determinant of response to histone deacetylase inhibitors (HDIs) - the association with histone acetylation in PBMCs at 24 h is consistent with a hypothesis that potent HDIs are needed for a critical threshold of drug exposure and durable activity.

Indexed as

AcetylationAntibiotics, AntineoplasticATP Binding Cassette Transporter, Subfamily BATP Binding Cassette Transporter, Subfamily B, Member 1BiopsyDepsipeptidesFetal HemoglobinHistone Deacetylase InhibitorsHistonesHumansImmunoblottingLeukocytes, MononuclearLymphoma, T-CellLymphoma, T-Cell, PeripheralReverse Transcriptase Polymerase Chain ReactionSkin NeoplasmsABCB1 protein, humanAntibiotics, AntineoplasticATP Binding Cassette Transporter, Subfamily BATP Binding Cassette Transporter, Subfamily B, Member 1DepsipeptidesFetal HemoglobinHistone Deacetylase InhibitorsHistonesromidepsin

Identifiers

PMID19874311
PMCPMC2838427
OpenAlexW2161755443

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.