Romidepsin in Conditioning and Maintenance in Patients with T-cell Leukemia or Lymphoma Undergoing Donor Stem Cell Transplant

Inclusion Criteria

• Diagnosis of either cutaneous T-cell lymphoma; T-prolymphocytic leukemia; T-large granulocytic leukemia; T-lymphoblastic leukemia/lymphoma; or peripheral T-cell lymphoma, natural killer/T-cell lymphoma for whom allogeneic stem cell transplantation is indicated
• An 10/10 or 8/8 human leukocyte antigen (HLA) matched (high resolution typing at A, B, C, DRB1, DQ1) sibling or unrelated donor
• Ejection fraction (EF) >= 50% on multi gated acquisition (MUGA) scan or echocardiogram
• Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and corrected diffusing capacity of the lungs for carbon monoxide (DLCO) >= 40%
• Estimated serum creatinine clearance >= 50 ml/min (using the Cockcroft-Gault formula) and/or serum creatinine =< 1.6 mg/dL; renal function will be calculated using ideal body weight (IBW), unless a patient weighs > 40% of their IBW, then adjusted body weight will be utilized
• Serum bilirubin =< 1.5 x upper limit of normal
• Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) =< 2 x upper limit of normal
• Able to sign informed consent
• Men and women of reproductive potential must agree to follow accepted birth control methods for the duration of the study; female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study; male subject agrees to use an acceptable method for contraception for the duration of the study

Exclusion Criteria

• Patient with active central nervous system (CNS) disease
• Pregnancy (positive beta human chorionic gonadotropin [HCG] test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization) or currently breast-feeding; pregnancy testing is not required for post-menopausal or surgically sterilized women
• Active hepatitis B, either active carrier (hepatitis B surface antigen positive [HBsAg +]) or viremic (hepatitis B virus [HBV] deoxyribonucleic acid [DNA] >=10,000 copies/mL, or >= 2,000 IU/mL)
• Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic hepatitis C or positive hepatitis C serology
• Human immunodeficiency virus (HIV) infection
• Active uncontrolled bacterial, viral or fungal infections
• Exposure to other investigational drugs within 4 weeks before enrollment
• Grade >= 3 non-hematologic toxicity from previous therapy that has not resolved to =< grade 1
• Radiation therapy to head and neck (excluding eyes), and internal organs of chest, abdomen or pelvis in the month prior to enrollment
• Prior whole brain irradiation
• Prior autologous stem cell transplant (SCT) in the prior 12 months
• Congenital QT syndrome, corrected QT (QTc) > 500 ms
• Myocardial infarction within 1 year of study entry; subjects with a history of myocardial infarction between 6 and 12 months prior to study entry 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 electrocardiogram (EKG) abnormalities including second (2nd) degree atrio-ventricular (AV) block type II, third (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; 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 EKG 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 and/or ejection fraction < 40% by MUGA scan or < 50% by echocardiogram and/or magnetic resonance imaging (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, i.e., blood pressure (BP) of >= 160/95; patients who have a history of hypertension controlled by medication must be on a stable dose and meet all other inclusion criteria; or
• Any cardiac arrhythmia requiring an anti-arrhythmic medication (excluding stable doses of beta-blockers)
• Patients taking drugs leading to significant QT prolongation where the interaction is too great to proceed with romidepsin
• Concomitant use of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors where the interaction is thought too great to proceed with romidepsin