New drug combo aims to keep rare lymphoma at bay after transplant
NCT ID NCT01908777
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether giving the drug romidepsin after a high-dose chemotherapy and stem cell transplant could help people with T-cell non-Hodgkin lymphoma stay in remission longer. Forty-seven patients participated. The goal was to see if this maintenance therapy improves progression-free survival at two years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Romidepsin (Istodax)
- What this could lead to
- If successful, this approach could help keep T-cell lymphoma in remission longer after a stem cell transplant.
- What could go wrong
- This is a small, phase 2 study with only 47 participants. The drug may cause side effects, and results may not apply to all patients.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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47 people
The number who actually took part.
- Started
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Jul 2013
- Finished
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Oct 2025
- Lead sponsor
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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
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16 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Age: Patients over age 16 who are deemed eligible for transplant by their treating physician Disease status: CR or PR required. Remission status will be assessed at the completion of induction chemotherapy and prior to enrollment on protocol. Diagnosis: The following histologies will need to be confirmed at MSK or locally for participating sites in order to be considered for HDT-ASCT and post-transplant maintenance romidepsin: * PTCL * AITL * ALCL * EaTCL * Hepatosplenic Gamma Delta T cell lymphoma * Adult T-cell leukemia/lymphoma * Primary cutaneous gamma/delta T-cell lymphoma * Extranodal NK/T-cell lymphoma, nasal type * Primary cutaneous anaplastic large cell lymphoma * Subcutaneous panniculitis-like T-cell lymphoma * Mycosis fungoides/sezary syndrome Stem cell collection: A minimum of 2 x 106 CD34+ cells must have been collected Laboratory test results within these ranges: * Total bilirubin \<= 1.5 x ULN * AST (SGOT) and ALT (SGPT) \<= 3 x ULN Exclusion Criteria: * Diagnosis: progressive disease at transplant work-up * Prior therapy: prior autologous or allogeneic transplant * Active and uncontrolled infection at time of transplantation including active infection with Aspergillus or other mold, or HIV infection * Inadequate performance status/organ function defined by DLCO \< 50% (adjusted for hgb), cardiac function as defined below, KPS \< 60%. * Pregnant or breast feeding. For males and females of child-producing potential, inability to use effective contraceptive methods during the study * Prior therapy with romidepsin * Central nervous system or meningeal involvement * Any known cardiac abnormalities such as: * Congenital long QT syndrome * QTc interval ≥ 500 milliseconds * Myocardial infarction within 6 months of transplantation. Subjects with a history of myocardial infarction between 6 and 12 months prior to transplant 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 Appendix 1) 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 Appendix 2) 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 unless currently addressed with an automatic implantable cardioverter defibrillator (AICD) * Hypertrophic cardiomegaly or restrictive cardiomyopathy from prior treatment or other causes * Uncontrolled hypertension, defined as 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 * Any cardiac arrhythmia requiring an anti-arrhythmic medication (excluding stable doses of beta-blockers) * Patients taking drugs leading to significant QT prolongation within the specified wash out period (See Appendix 3: Medications That May Cause QTc Prolongation). * Concomitant use of CYP3A4 inhibitors
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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.
Contacts and locations
Locations
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Fred Hutchinson Cancer Research Center (Data Collection Only)
Seattle, Washington, 98109, United States
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Memorial Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 11065, United States
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Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, 11725, United States
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Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
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Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
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Moffitt Cancer Center
Tampa, Florida, 33612, United States
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University of Washington (Data Collection Only)
Seattle, Washington, 98109, United States
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Weill Cornell Medical Center
New York, New York, United States
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Other studies related to the condition(s) this trial covers.
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