A Phase 2 Multicenter Study of High Dose Chemotherapy With Autologous Stem Cell Transplant Followed by Maintenance Therapy With Romidepsin for the Treatment of T Cell Non-Hodgkin Lymphoma

Completed · Phase 2

Conditions studied: T Cell Non-Hodgkin Lymphoma

In brief

The purpose of this study is to test the benefit of a chemotherapy drug called romidepsin in patients with T Cell Non-Hodgkin Lymphoma (T NHL) who have undergone autologous transplantation.

Key facts

Study ID

NCT01908777

Run by

Memorial Sloan Kettering Cancer Center

People needed

47

Starts

2013-07-16

Expected to finish

2025-10-03

Last updated by the study team

2025-10-09

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Moffitt Cancer Center — Tampa, Florida, United States
• Memorial Sloan Kettering Cancer Center — Basking Ridge, New Jersey, United States
• Memorial Sloan Kettering Monmouth — Middletown, New Jersey, United States
• Memorial Sloan Kettering Cancer Center @ Suffolk — Commack, New York, United States
• Memorial Sloan Kettering Westchester — Harrison, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Weill Cornell Medical Center — New York, New York, United States
• Memorial Sloan Kettering Nassau — Uniondale, New York, United States
• Fred Hutchinson Cancer Research Center (Data Collection Only) — Seattle, Washington, United States
• University of Washington (Data Collection Only) — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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