Safety Study of CAT-8015 Immunooxin in Patients With HCL With Advance Disease

Exclusion Criteria

• •Documented and ongoing central nervous system involvement with their malignant disease (history of CNS involvement is not an exclusion criterion)
• •History of bone marrow transplant
• •Pregnant or breast-feeding females
• •Patients whose plasma contains either a significant level of antibody to CAT-8015 as measured by ELISA, or antibody that neutralizes the binding of CAT-8015 to CD22 as measured by a competition ELISA.
• •HIV positive serology (due to increased risk of severe infection and unknown interaction of CAT-8015 with antiretroviral drugs)
• •Hepatitis B surface antigen positive
• •Uncontrolled, symptomatic, intercurrent illness including but not limited to: infections requiring systemic antibiotics, congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness, or social situations that would limit compliance with study requirements
• •Hepatic function: serum transaminases (either ALT or AST) or bilirubin:
• •≥ Grade 2, unless bilirubin is due to Gilbert's disease
• •Renal function: serum creatinine clearance ≤60mL/min as estimated by Cockroft-Gault formula
• •Hematologic function:
• •The ANC \<1000/cmm, or platelet count \<50,000/cmm, if these cytopenias are not judged by the investigator to be due to underlying disease (i.e. potentially reversible with anti-neoplastic therapy)
• •Baseline coagulopathy \> grade 3 unless due to anticoagulant therapy
• •A patient will not be excluded because of pancytopenia ≥ Grade 3, or erythropoietin dependence, if it is due to disease, based on the results of bone marrow studies
• •Pulmonary function:
• •Patients with \< 50% of predicted forced expiratory volume (FEV1) or \<50% of predicted diffusing capacity for carbon monoxide (DLCO), corrected for hemoglobin concentration and alveolar volume. Note: Patients with no prior history of pulmonary illness are not required to have PFTs. FEV1 will be assessed following bronchodilator therapy.
• •Recent prior therapy:
• •Cytotoxic chemotherapy (except stable doses of prednisone), whole body electron beam radiation therapy, interferon, retinoids or other systemic therapy, or investigational therapy of the malignancy for 3 weeks prior to entry into the trial
• •Less than or equal to \< 3 months prior monoclonal antibody therapy (i.e. rituximab)
• •Patients who have received or are receiving radiation therapy less than 3 weeks prior to study entry will be not be excluded providing the volume of bone marrow treated is less than 10% and also the patient has measurable disease outside the radiation port
• •Any history of pseudomonas-exotoxin (PE) immunotoxin administration