A Phase I/II, a Single Arm, Open-label Study of Ofatumumab (GSK1841157) in Patients With Previously Treated Chronic Lymphocytic Leukemia

Exclusion Criteria

• •A subject will not be eligible for inclusion in this study if any of the following criteria is met:
• •Active malignancy which needs therapy with anti-cancer drug, except for CLL.
• •Known Richter's transformation.
• •Previous autologous stem cell transplantation, within 24 weeks prior to screening.
• •Previous allogenic stem cell transplantation.
• •Known CNS involvement.
• •History of significant cerebrovascular disease.
• •Current cardiac disease requiring medical treatment (e.g. atrial flutter treated with acetylsalicylic acid and beta blocking agents).
• •Chronic or active infectious disease requiring systemic (intravenous or oral) treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis and tuberculosis.
• •Suspected/known immediate or delayed hypersensitivity to components of ofatumumab.
• •Patients previously treated with ofatumumab.
• •Positive serology test for any of HBsAg, anti-HBcAb or anti-HCVAb. If only anti-HBcAb results is positive, HBV-DNA test will be performed. If HBV-DNA results in negative, the patient is eligible.
• •HIV positivity.
• •Pregnant or lactating women.
• •Women of childbearing potential not willing to use adequate contraception during the study and one year after the last dose of ofatumumab, and male patients not willing to use adequate contraception during the study. Adequate contraception is defined as follows but not limited to; Abstinence. Oral Contraceptive (exclude oral progesterone alone). Intrauterine device (IUD) or intrauterine system (IUS). Male partner sterilization. Double barrier method: condom or occlusive cap (diaphragm or cervical / vault caps) plus spermicidal agent (gel / film) etc.
• •Use of an investigational drug within 4 weeks prior to screening.
• •Current participation in any other clinical study.
• •Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease.
• •Patients who an investigator (or sub investigator) judges ineligible to this study.
• •Note; Child-bearing potential: a woman with functioning ovaries and uterine, or no documented sterility (i.e., a woman with functioning ovaries who have a current documented tubal ligation, women who have had a hysterectomy, women who are post-menopausal, or women who have had both ovaries surgically removed).