|Exclusion Criteria:||1) Any previous cancer therapy this lymphoma, with the exception of: 1) Rituximab in combination with an anthracycline- or anthracenedione-based chemotherapy. 2) Monotherapy rituximab, dosed prior to first-line rituximab combined with chemotherapy, or as maintenance therapy; 3) Radiotherapy as part of the first-line treatment plan; 4) Radiotherapy to a limited field at a maximum dose of </=10Gy to control life threatening symptoms.|
2) Received any of the following treatments within 2 weeks prior to start of study therapy (unless otherwise stated): Anti-cancer therapy (e.g. alkylating agents, anti-metabolites, purine analogues); Radiotherapy with the exception of radiotherapy to a limited field at a maximum dose of </=10Gy to control life-threatening symptoms.
3) Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to enrollment, whichever is longer or currently participating in any other interventional clinical study
4) Glucocorticoid therapy in doses >1mg/kg/day prednisolone (or equivalent dose of other glucocorticoid).
5) History of significant cerebrovascular disease or event with significant symptoms or sequelae, unless in the opinion of the investigator it does not contraindicate participation in the study.*
6) Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to enrollment, congestive heart failure (NYHA III-IV), and arrhythmia unless controlled by therapy, with the exception of extra systoles or minor conduction abnormalities, unless in the opinion of the investigator it does not contraindicate participation in the study.*
7) Significant concurrent, uncontrolled medical condition, unless in the opinion of the investigator it does not contraindicate participation in this study.*
8) Known or suspected hypersensitivity to study treatments, unless in the opinion of the investigator it does not contraindicate participate in the study.*
9) Known HIV positivity.
10) Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded.
11) Active hepatitis C infection.
12) 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 and tuberculosis.
13) Other past or current malignancy unless in the opinion of the investigator it does not contraindicate participation in the study. For example, subjects who have been free of malignancy for at least 5 years, or have a history of completely resected nonmelanoma skin cancer, or successfully treated in situ carcinoma are eligible.*
14) Prior treatment with anti-CD20 monoclonal antibodies, with the exception of rituximab.
15) Screening laboratory values: ICE regimen: platelets <50x10^9/L and neutrophils <1.0 x 10^9/L (unless due to lymphoma involvement of the bone marrow); DHAP regimen: platelets <100x10^9/L and neutrophils <1.5 x 10^9/L (unless due to lymphoma involvement of the bone marrow); measured 12 or 24-hour creatinine clearance of <50mL/min total If a measured creatinine clearance is not available then estimated creatinine clearance is acceptable; total bilirubin >1.5 times upper normal limit in the absence of a known history of Gilbert's disease (unless due to lymphoma involvement of liver)
16) Continuation #15) ALT >2.5 times upper normal limit (unless due to lymphoma involvement of the liver); alkaline phosphatase >2.5 times upper normal limit (unless due to lymphoma involvement of the liver)
17) Subjects known or suspected of being unable to comply with the study protocol.
18) Pregnant or lactating women.
19) 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 ofatumumab therapy. Adequate contraception is defined as hormonal birth control, intrauterine device, double barrier method or total abstinence. Women of childbearing potential must have a negative pregnancy test prior at screening.
20) Male subjects unable or unwilling to use adequate contraception methods from the time of first dose of study medication until one year after the last dose of ofatumumab.
21) * The GSK Medical Monitor is available to discuss subject eligibility for all criteria.