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Phase IIB Study of Azacytidine Plus Romidepsin for PTCL

This study is for people with relapsed or refractory Peripheral T-cell Lymphoma (PTCL), a type of non-Hodgkin lymphoma, who have already received one treatment. It aims to see if combining two drugs, oral azacytidine and romidepsin, is safe and effective. This combination will be compared to standard treatments chosen by the doctor, which could be romidepsin, belinostat, pralatrexate, or gemcitabine alone. The study will enroll about 50 participants aged 18 and older. The main goal is to measure how long participants live without their cancer getting worse (progression-free survival). The study status is currently unclear.

Study design
This is a randomized Phase IIB study comparing a drug combination to standard treatments. It plans to enroll about 50 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from the day of randomization until their disease progresses, they pass away, or for up to 72 weeks for those without an event.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04747236

Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Virginia
~50 participants
Updated 2026-01-21 on ClinicalTrials.gov
What's tested:AzacytidineRomidepsinBelinostatPralatrexateGemcitabine

At a glance

Recruiting sites
5 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression free survival
Measured over Day of randomization to day of progression or death, whichever comes first; or date of last disease assessment or date of transition to other treatment for those without an event, up to 72 weeks.

Conditions

PTCL

Explore related trials

Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma

NCT04747236

Where you'd take part

This study runs at 6 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Duke University

    Durham, North Carolinastudy coordinator listed

    Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New Yorkstudy coordinator listed

    Recruiting

  • The Ohio State University

    Columbus, Ohiostudy coordinator listed

    Not yet recruiting

  • University of Virginia

    Charlottesville, Virginiastudy coordinator listed

    Recruiting

  • VA Long Beach Health Care System

    Long Beach, Californiastudy coordinator listed

    Recruiting

  • Yale Cancer Center

    New Haven, Connecticutstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Craig Portell, MD · PRINCIPAL_INVESTIGATOR · University of Virginia

Who to contact

Craig Portell, MD
[email protected]
434-924-9637
Email the study team

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Eligibility criteria

Inclusion

Any cardiac arrhythmia requiring an anti-arrhythmic medication (excluding stable doses of beta-blockers)

Exclusion

Congenital long QT syndrome
QTc interval ≥ 500 millisecond (using the Fridericia formula)
Patients taking drugs leading to significant QT prolongation (See Section 13.2)
Myocardial infarction within 6 months of C1D1. \[Subjects with a history of myocardial infarction between 6 and 12 months prior to C1D1 who are asymptomatic and have had a negative cardiac risk assessment (treadmill stress test, nuclear medicine stress test, or stress echocardiogram) since the event, may participate\];
Other significant ECG abnormalities including 2nd degree atrio-ventricular (AV) block type II, 3rd degree AV block, or bradycardia (ventricular rate less than 50 beats/min);
Symptomatic coronary artery disease (CAD), e.g., angina Canadian Class II-IV (see Section 13.4) In any patient in whom there is doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present;
An ECG recorded at screening showing evidence of cardiac ischemia (ST depression of ≥2 mm, measured from isoelectric line to the ST segment). If in any doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present;
Congestive heart failure (CHF) that meets New York Heart Association (NYHA) Class II to IV definitions (see Section 13.5) and/or ejection fraction \<40% by MUGA scan or \<50% by echocardiogram and/or MRI;
A known history of sustained ventricular tachycardia (VT), ventricular fibrillation (VF), Torsade de Pointes, or cardiac arrest;
Hypertrophic cardiomegaly or restrictive cardiomyopathy from prior treatment or other causes;

What this trial measures

  • Progression free survivalDay of randomization to day of progression or death, whichever comes first; or date of last disease assessment or date of transition to other treatment for those without an event, up to 72 weeks.

    Difference in progression free survival in subjects treated with AZA/ROMI versus pre-specified investigator choice.