Status:
COMPLETED
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
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
University of Washington
Weill Medical College of Cornell University
Conditions:
T Cell Non-Hodgkin Lymphoma
Eligibility:
All Genders
16+ years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
The primary aim is to determine a preliminary estimate of the progression-free survival of patients with T NHL who receive maintenance romidepsin at 2 years post-transplant for patients transplanted i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 16 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 3 2025
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT01908777
Start Date
July 16 2013
End Date
October 3 2025
Last Update
October 9 2025
Active Locations (10)
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1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
2
Memorial Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
3
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
4
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, United States, 11725