| Eligibility |
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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