Ofatumumab with or without Bendamustine Hydrochloride in Treating Patients with Mantel Cell Lymphoma That Are Ineligible for Stem Cell Transplant

Inclusion Criteria

• Untreated, non-transplant eligible, newly diagnosed mantle cell lymphoma with measurable disease as determined by computed tomography (CT), and bone marrow biopsy
• Subjects must not be candidates for intensive high-dose chemotherapy, with or without an autologous stem cell transplant (ASCT), due to one or more of the following factors: * Age >= 65 years: Patients < 65 years of age must be ineligible for high-dose chemotherapy (HDT)/ASCT on the basis of comorbidity, organ dysfunction or patients refusal for HDT/ASCT * Comorbid disease, such as coronary artery disease (CAD), congestive heart failure (CHF), pulmonary dysfunction, liver or kidney dysfunction, precluding high dose therapy secondary to expected increased morbidity and mortality: poor performance status (Karnofsky performance scale [KPS] 70% or less); ejection fraction < 45%; impaired pulmonary function test with diffusing capacity of lung for carbon monoxide (DLCO) < 50% expected * Patient refusal * Medical conditions which in the opinion of the treating physician and DMT preclude HDT/ASCT
• Patients must have a serum creatinine clearance >= 40 mL/min (as per the Jelliffe method) or by 12-hour or 24-hour urine creatinine clearance
• Patients must have absolute neutrophil count (ANC) > 1000/mcl
• Platelets > 100,000/mcl (unless secondary to MCL)
• Patients must have a bilirubin level of < 2.0 mg/dl in the absence of a history of Gilbert's disease (or pattern consistent with Gilbert's)
• Negative serologies for hepatitis B (HB) defined as a negative test for HB surface antigen (sAg); in addition, if negative for HBsAg but HB core antibody (cAb) positive (regardless of HBsAb status), a HB deoxyribonucleic acid (DNA) test will be performed and if negative, patient may be included but must undergo hepatitis B virus (HBV) DNA polymerase chain reaction (PCR) testing at the beginning of treatment and throughout treatment duration, at least every 2 months; in addition patients will require treatment with Entecavir 0.5 mg orally (PO) a day (qday) per Memorial Sloan Kettering Cancer Center (MSKCC) institutional guidelines
• No active co-morbid cardiac condition such as active CHF or CAD
• KPS performance >= 70%
• Histologically confirmed mantle cell lymphoma classified according to World Health Organization (WHO) criteria confirmed at MSKCC
• No prior treatment for mantle cell lymphoma with the exception of corticosteroids for 7 days or less, or 1 course of involved-field radiation
• No prior malignancies within 5 years, unless treated early stage breast cancer, treated carcinoma in situ of the cervix, resected skin malignancies, or treated prostate cancer
• Women who are pre-menopausal must have a negative serum pregnancy test; subjects must agree to use appropriate contraception until 4 weeks after the completion of chemotherapy
• Patients must be human immunodeficiency virus (HIV) negative, and have negative serologies for hepatitis C

Exclusion Criteria

• Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, hepatic involvement by MCL, or stable chronic liver disease per investigator assessment)
• Known pregnancy or breast feeding
• Medical illness unrelated to MCL within the prior one month that will preclude administration of chemotherapy safely; this includes patients with uncontrolled infection, chronic renal insufficiency, myocardial infarction within the past 6 months, unstable angina, active congestive heart failure, cardiac arrhythmias other than chronic atrial fibrillation and chronic active or persistent hepatitis