Drug-drug Interaction Study of Ofatumumab With Bendamustine in Subjects With Indolent B-cell Non-Hodgkin's Lymphoma

Inclusion Criteria

• •Subjects with previously untreated or relapsed indolent B-cell NHL requiring treatment. Indolent NHL is defined as small lymphocytic lymphoma (SLL), lymphoplasmacytic lymphoma (LPL), marginal zone lymphoma (MZL), and follicular lymphoma (FL); grades 1, 2, and 3A, defined according to WHO guidelines. Tumor verified to be CD20+ positive from a previous or current lymph node biopsy.
• •At least 4 weeks after previous anti-cancer chemotherapy, or radiotherapy treatment.
• •At least 12 weeks after previous anti-CD20 radioimmunotherapy, anti-CD20 antibody treatment, and non-anti-CD20 monoclonal antibody treatment.
• •Subjects who give consent to this study participation and sign the informed consent form.
• •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
• •Age greater than or equal to 18 years at informed consent.
• •A female subject is eligible to participate if she is of Non-childbearing potential or required to use a contraception method.
• •Male subjects with female partners of child-bearing potential must agree to use a contraception method.
• •Subjects must agree to use contraception until 12 months after the last dose of study drug.
• •History of significant cerebrovascular disease or event with significant symptoms or sequelae (as judged by the investigator).
• •Significant concurrent, uncontrolled medical condition that in the opinion of the investigator contraindicates participation this study.
• •Positive serology for Hepatitis B (HB) defined as a positive test for Hepatitis B 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 DNA test will be performed and if positive the subject will be excluded. If HBV DNA is negative, the subject may be included but must undergo Hepatitis B virus (HBV) DNA monitoring (see Section 7.7.5). Prophylactic antiviral therapy may be initiated at the discretion of the investigator.
• •Current active liver or biliary disease (subjects with Gilbert's syndrome or asymptomatic gallstones, liver metastases related to indolent NHL or otherwise stable chronic liver disease per investigator assessment, are eligible).
• •Known human immunodeficiency virus (HIV) positive.
• •Screening laboratory values:
• •* platelets \< 100 x 109/L (unless due to lymphoma involvement of the bone marrow)
• •* neutrophils \< 1.5 x 109/L (unless due to lymphoma involvement of the bone marrow)
• •* total bilirubin \> 1.5 times ULN (unless due to liver involvement by lymphoma or Gilbert's syndrome)
• •* transaminases \> 2 times ULN
• •Known or suspected hypersensitivity to ofatumumab, bendamustine, or mannitol.
• •Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half-lives or 4 weeks prior to Visit 1, whichever is longer or currently participating in any other interventional clinical study
• •Lactating women, women with a positive pregnancy test at Visit 1, or women (of childbearing potential) as well as men with partners of childbearing potential, who are not willing to use adequate contraception until 12 months after the last dose of study drug. Adequate contraception is defined in Section 8.1.