A Trial of the Safety of Escalating Doses of PRO131921 in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Exclusion Criteria

• •Prior use of anti-CD20 monoclonal antibody therapy (other than rituximab)
• •Prior use of any non-CD20 targeted monoclonal antibody therapy within 6 months of enrollment
• •Current or recent CLL treatment
• •History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies
• •Evidence of acute/active autoimmune hemolytic anemia or other autoimmune complications of CLL
• •Use of hematopoietic growth factors or RBC and/or platelet transfusions
• •Evidence of significant uncontrolled concomitant diseases, such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders
• •Evidence of myelodysplasia or myelodysplastic changes on bone marrow examination
• •History of cancer other than CLL)
• •Known active bacterial, viral, fungal, mycobacterial, or other infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics or oral antibiotics
• •A major episode of infection requiring hospitalization or treatment with IV antimicrobials within 4 weeks of screening or oral antimicrobials within 2 weeks of screening
• •Positive hepatitis B or C serology
• •Positive human immunodeficiency virus (HIV) serology
• •Active cytomegalovirus (CMV) disease by antigen or polymerase chain reaction testing
• •Pregnancy or lactation
• •CNS leukemia
• •Recent major surgery, other than diagnostic surgery