Phase I/II Study of Different Doses and Dose Schedules of Milatuzumab (hLL1) in CLL

Exclusion Criteria

• •Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test Pregnancy testing is not required for post-menopausal or surgically sterilized women
• •Women of childbearing potential and fertile men who are not practicing or who are unwilling to practice birth control while enrolled in the study until at least 12 weeks after the last milatuzumab infusion
• •Prior therapy with other human or humanized monoclonal antibodies, unless HAHA tested and negative;
• •Bulky disease by CT, defined as any single mass \>10 cm in its greatest diameter
• •Known HIV positive or active hepatitis B or C, or presence of hepatitis B surface antigens or presence of hepatitis C antibody
• •Known autoimmune disease or presence of autoimmune phenomena
• •At least 7 days beyond any infection requiring antibiotic use.
• •Systemic corticosteroids within 2 weeks, except low dose regimens (prednisone, \<20 mg/day, or equivalent) which may continue if unchanged.
• •Substance abuse or other concurrent medical or psychiatric conditions that, in the Investigator's opinion, could confound study interpretation or affect the patient's ability to tolerate or complete the study.