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New drug cocktail aims to outsmart tough blood cancer

NCT ID NCT04747236

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests if a combination of two drugs (romidepsin and oral azacytidine) works better than standard single drugs for people with peripheral T-cell lymphoma (PTCL) that has returned or not responded to prior therapy. About 50 adults will be randomly assigned to either the combo or a standard drug chosen by their doctor. The main goal is to see if the combo delays cancer growth longer.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2021

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: Patients must have histologically confirmed relapsed or refractory peripheral T-cell lymphoma as defined by 2016 WHO criteria (Section 13.7), who have progressed following one line of prior systemic therapy. 1. Patients are required to have no more than 3 lines of prior therapy (with cytoreductive therapy \[ex ICE, DHAP, etc.\] followed by autologous stem cell transplant counting as one line of therapy). Patients are eligible if they have relapsed after prior autologous or allogeneic stem cell transplant. 2. Patients with anaplastic large cell lymphoma are required to have received brentuximab vedotin (Bv) prior to study enrollment. 3. Measurable Disease as defined in Section 8.1.3.1. 4. Age ≥18 years. 5. ECOG performance status ≤2 6. Patients must have adequate organ and marrow function as defined below: Absolute neutrophil count (ANC): ≥1000/mm3 (≥1000/dL); Platelets: \> 75,000/mm3; Serum Creatinine:\< 2 x ULN OR creatinine clearance \>50 mL/min/for patients with creatinine levels above ULN; Bilirubin: ≤ 1.5 x ULN (except in patients with Gilbert's disease, where bilirubin to 4x ULN is allowed); AST and ALT: ≤ 2 x ULN OR ≤ 3 X ULN in presence of demonstrable liver involvement; Serum potassium: ≥ 3.8 mmol/L; Serum magnesium≥1.8 mg/dL. 7. Negative urine or serum pregnancy test for females of childbearing potential 8. All females of childbearing potential and male subjects must agree to use an effective method of contraception (see section 5.4 for more details) 9. Be willing and able to provide written consent or assent for the trial. Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Diagnosis of patch/plaque stage mycosis fungoides 2. Prior Therapy: Prior exposure to any hypomethylating agent or any histone deacetylase inhibitor (ex: romidepsin, chidamide, belinostat, or vorinostat); exposure to chemotherapy or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier. 3. Systemic steroids that have not been stabilized to the equivalent of ≤10 mg/day prednisone prior to the start of the study drugs. 4. No other concurrent investigational agents are allowed within 2 weeks of enrollment. 5. Known central nervous system metastases, including lymphomatous meningitis 6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 7. Nursing women 8. Other active concurrent malignancy (except non-melanoma skin cancer, carcinoma in situ of the cervix, or carcinoma in situ of the breast (DCIS or LCIS). If there is a history of prior malignancy, the patient must be disease-free for ≥ 3-years. Patients whose lymphoma has transformed from a less aggressive histology remain eligible. 9. Patients known to be Human Immunodeficiency Virus (HIV)-positive. 10. Patients with active Hepatitis A, hepatitis B, or hepatitis C infection. 11. Concomitant use of CYP3A4 inhibitors (see Section 13.3) 12. History of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis), celiac disease (ie, sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption, distribution, metabolism or excretion of the study drug and/or predispose the subject to an increased risk of gastrointestinal toxicity 13. Abnormal coagulation parameters (PT \>15 seconds, PTT\>40 seconds, and/or INR \>1.5) unless related to ongoing anticoagulation treatment required by the patient. 14. Known or suspected hypersensitivity to azacitidine (or any excipients in the formulation) or mannitol. 15. Any known cardiac abnormalities such as: * 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; * Uncontrolled hypertension, i.e., blood pressure (BP) of ≥160/95; patients who have a history of hypertension controlled by medication must be on a stable dose (for at least one month) and meet all other inclusion criteria; or * Any cardiac arrhythmia requiring an anti-arrhythmic medication (excluding stable doses of beta-blockers)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Duke University

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • The Ohio State University

    NOT_YET_RECRUITING

    Columbus, Ohio, 43210, United States

  • University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22911, United States

  • VA Long Beach Health Care System

    RECRUITING

    Long Beach, California, 90822, United States

  • Yale Cancer Center

    RECRUITING

    New Haven, Connecticut, 06520, United States

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