Bortezomib and Romidepsin in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •\* Diagnosis of 1 of the following:
• •CLL or SLL, relapsed or refractory
• •Indolent B-cell lymphoma, relapsed or refractory:
• •* Follicle center lymphoma, follicular or diffuse
• •* Marginal zone B-cell lymphoma (splenic, nodal, extranodal \[this includes mucosa associated lymphoid tissue (MALT)\])
• •* Lymphoplasmacytic lymphoma
• •PTCL, relapsed or refractory:
• •* Anaplastic large cell lymphoma, anaplastic lymphoma kinase (ALK)-positive
• •* Anaplastic large cell lymphoma, ALK-negative
• •* Angioimmunoblastic T-cell lymphoma
• •* Enteropathy-associated T-cell lymphoma
• •* Extranodal natural killer (NK)/T-cell lymphoma, nasal type
• •* Hepatosplenic T-cell lymphoma
• •* PTCL, not otherwise specified (NOS)
• •* Subcutaneous panniculitis-like T-cell lymphoma
• •CTCL:
• •\* CTCL with subtypes of mycosis fungoides Stage IB or higher, Sézary syndrome, or primary cutaneous anaplastic large cell lymphoma who have failed a previous systemic treatment, as per the following:
• •* Stage IA plaque, IB, or IIA: At least 4 prior conventional and/or experimental regimens (topical or systemic, including psoralen-ultraviolet light \[PUVA\] and systemic corticosteroids)
• •* Stage IIB, III, or IV: At least 1 prior systemic regimen (systemic corticosteroids alone or PUVA alone do not count as systemic regimens for this purpose) NOTE: Repeated use of the same regimen is considered 1 regimen
• •Prior allogeneic stem cell transplant is allowed provided that all of the following conditions are met:
• •* \>= 6 months have elapsed since allogeneic transplant
• •* No Graft vs. Host Disease (GVHD) is present
• •* Not currently on immunosuppressive therapy
• •No prior or concurrent CNS malignancy
• •PATIENT CHARACTERISTICS:
• •ECOG performance status 0-1
• •ANC \> 1,500/mm\^3
• •Platelet count \> 75,000/mm\^3
• •Hemoglobin \> 7.5 g/dL (transfusion allowed)
• •Serum creatinine ≤ 1.2 mg/dL or actual or calculated creatinine clearance \> 60 mL/min
• •AST and ALT ≤ 2.5 times upper limit of normal (ULN)
• •Bilirubin ≤ ULN
• •Serum potassium ≥ 3.5 mEq/L (supplementation allowed)
• •Serum magnesium ≥ 1.7 mEq/L (supplementation allowed)
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective non-hormonal contraception
• •Willing and able to comply with protocol requirements
• •No prior severe allergic reactions to bortezomib, boron, mannitol, or romidepsin
• •No progressing toxicity secondary to bortezomib
• •No grade 1 peripheral neuropathy with pain or ≥ grade 2 peripheral neuropathy by NCI-CTCAE criteria (v4.0) within the past 14 days
• •No condition related to ischemic heart disease, heart failure, or the risk of torsades de pointes or sudden cardiac death, including any of the following:
• •* History of sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes, or resuscitated cardiac arrest unless currently addressed with an implantable cardiac defibrillator
• •* Baseline heart rate \> 140 beats per minute
• •* Known congenital long QT syndrome
• •* QTc interval \> 480 milliseconds
• •* Type II second-degree atrio-ventricular (AV) block, third-degree AV block, or ventricular rate \< 50 beats per minute
• •* Myocardial infarction within the past 6 months
• •* Patients who have had a myocardial infarction 6-12 months ago are eligible provided they are asymptomatic and have a negative cardiac risk assessment (i.e., treadmill stress test, nuclear medicine stress test, or stress echocardiogram)
• •* Angina upon ordinary physical activity
• •* Angina only with strenuous, rapid, or prolonged exertion allowed
• •* ECG with evidence of cardiac ischemia, as defined by the following:
• •* ST depression of ≥ 2 mm, measured from isoelectric line to ST segment
• •* T-wave inversion ≥ 4 mm, measured from isoelectric line to peak of T-wave
• •* NYHA class II-IV congestive heart failure
• •* Known left ventricular ejection fraction \< 40% by MUGA scan or \< 50% by echocardiogram or MRI
• •* Known hypertrophic cardiomegaly or restrictive cardiomyopathy
• •No uncontrolled hypertension, defined as persistent blood pressure ≥ 160/95 mm Hg despite medical management
• •No clinically significant active infection, including known HIV infection or hepatitis B or C
• •No other malignancy within the past 3 years except completely resected basal cell carcinoma or squamous cell carcinoma of the skin, in situ malignancy, or curatively treated low-risk prostate cancer
• •No concurrent medical condition that, in the investigator's opinion, would compromise study treatment or assessment of toxicity
• •PRIOR CONCURRENT THERAPY:
• •See Disease Characteristics
• •At least 3 weeks since prior chemotherapy, radiation therapy or investigational agents. If steroids for cancer control have been used, patients must be off theses agents for at least 1 week before starting treatment. (Maintenance therapy for non-malignant disease with prednisone or steroid equivalent dose less than 10 mg/day is permitted)
• •Prior allogeneic stem cell transplantation allowed provided all of the following conditions are met:
• •Greater than or equal to 6 months have elapsed since allogeneic transplant
• •No Graft vs. Host Disease (GVHD) is present
• •More than 4 weeks since prior bortezomib
• •No concurrent oral hormonal contraceptives
• •No concurrent potent or moderate CYP3A4 inhibitors
• •No concurrent anti-arrhythmic agents
• •No concurrent treatment with any drugs that are generally accepted to having a risk of causing torsades de pointes (class 1 drugs)
• •* Class 2 or 3 drugs allowed at the discretion of the investigator
• •No other concurrent systemic therapy for the malignancy
• •Concurrent warfarin (coumadin) allowed