Ofatumumab and Fresh Frozen Plasma in Treating Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia

Inclusion Criteria

• Patients must have a pathological diagnosis of B-cell CLL
• Patients must have received prior rituximab therapy and must have recovered from all non-hematologic toxicities; (previous radiation is allowed as long as patients have recovered from all treatment related toxicities)
• Hemoglobin (Hgb) >= 9.0 g/dl
• Platelets >= 50,000/mm^3
• Creatinine =< 2.0 times the institutional upper limit of normal
• Serum glutamic oxaloacetic transaminase (SGOT)/serum glutamate pyruvate transaminase (SGPT) =< 2.5 times the institutional upper limit of normal (unless due to disease involvement of liver)
• Total bilirubin =< 1. 5 times the institutional upper limit of normal
• Alkaline phosphatase =< 2.5 times upper limit of normal (unless due to disease involvement of the liver or bone marrow)
• Patients must have a performance status of 0-2 by Eastern Cooperative Oncology Group (ECOG) criteria
• All patients must be informed of the investigational nature of this study and must sign and give written consent in accordance with institutional and federal guidelines

Exclusion Criteria

• Subjects who have current active hepatic or biliary disease (with the exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
• Having received rituximab within the prior 2 months
• Treatment with any known therapeutic or experimental therapy within 4 weeks prior to enrollment, or currently participating in any other interventional clinical study
• Other past or current malignancy; subjects who have been free of malignancy for at least 5 years, have a history of completely resected non-melanoma skin cancer, successfully treated in situ carcinoma, adequately treated basal or squamous cell skin cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer for which the patient has been disease-free for 5 years are eligible
• Prior treatment with anti-cluster of differentiation (CD)20 monoclonal antibody or alemtuzumab within 2 months prior to start of therapy
• Chronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active hepatitis C
• History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae
• Known human immunodeficiency virus (HIV) positive
• Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to randomization, congestive heart failure (New York Heart Association [NYHA] III-IV), and arrhythmia unless controlled by therapy, with the exception of extra systoles or minor conduction abnormalities
• Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which in the opinion of the investigator may represent a risk for the patient
• Positive serology for hepatitis B (HB) defined as a positive test for hepatitis B virus surface antigen (HBsAg); in addition, if negative for HBsAg but hepatitis B core antibody (HBcAb) positive (regardless of hepatitis B surface antibody [HBsAb] status), a HB deoxyribonucleic acid (DNA) test will be performed and if positive the subject will be excluded; HBsAg negative, HBsAb negative, HBsAb positive subjects can be included * Consult with a physician experienced in care & management of subjects with hepatitis B to manage/treat subjects who are anti-HBc positive * Monitoring criteria for HBcAb+ and HBV DNA negative subjects: ** If HBV DNA is negative, subject may be included but must undergo at least every 2 month HBV DNA polymerase chain reaction (PCR) testing from the start of treatment during the treatment course ** Monitoring during the follow-up period will be performed during routine study visits for a minimum follow-up period of six months after the last dose, as long as the subject remains on study; monitoring frequency during follow-up should occur at a minimum of every 2-3 months; whenever possible, the monitoring should occur as part of the routine follow-up visit (Note: for most studies, the follow-up visits are 1 month post-dose, 3 months post-dose and 6 months post-dose ** Prophylactic antiviral therapy may be initiated at the discretion of the investigator
• Positive serology for hepatitis C (HC) defined as a positive test for hepatitis C antibody (HCAb), in which case reflexively perform a HC recombinant immunoblot assay (RIBA) on the same sample to confirm the result
• Pregnant or lactating women; women of childbearing potential must have a negative pregnancy test at screening; women of child bearing potential must undergo pregnancy testing prior to each dose if the previous pregnancy test was greater than 14 days prior and a pregnancy test at 6 months after the last dose
• Women of childbearing potential, including women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from study start to one year after the last dose of protocol therapy; adequate contraception is defined as hormonal birth control, intrauterine device, double barrier method or total abstinence
• Male subjects unable or unwilling to use adequate contraception methods from study start to one year after the last dose of protocol therapy
• Receiving warfarin