Phase I Dose Escalation Study of IMMU-114 in Relapsed or Refractory NHL and CLL

Inclusion Criteria

• •Patients must have met the diagnostic criteria for CLL/SLL according to the IWCLL 2008 \[13\] or WHO Guidelines at some point during their disease course:
• •Patients with SLL: tumor biopsy immunohistochemistry diagnostic of SLL or blood/bone marrow immunophenotype similar to CLL without lymphocytosis and enlarged lymph nodes.
• •Patient must have relapsed or refractory CLL/SLL following at least one purine analog-containing regimen (or after one non-purine analog containing regimen if there is a relative contraindication to purine-analog containing therapy) and not have traditional options available or decline these. Patients with prolymphocytic leukemia (PLL)-CLL or PLL transformation of CLL are eligible.
• •Patients must meet IWCLL 2008 Guideline \[13\] criteria for active disease requiring treatment.
• •Patients with histologically confirmed B-cell NHL including marginal zone lymphoma, follicular lymphoma, or mantle cell lymphoma by WHO criteria.
• •Patients must have relapsed or refractory disease after at least one prior therapy and not have traditional options available or decline these.
• •Age ≥ 18 years
• •Able to understand and sign a written informed consent document.
• •Able to receive outpatient treatment and follow-up at the treating institution.
• •ECOG performance status 0-1.
• •Relapsed/refractory to at least one prior standard systemic treatment regimen, but no more than 4.
• •Completed all prior therapies (immunosuppressive medications, antineoplastic therapy, vaccination, immunotherapy, chemotherapy, radiotherapy, major surgery, etc) \>4 weeks prior to the first study dose of medication (alemtuzumab ≥ 6 months).
• •If receiving corticosteroids, ≤ 20 mg/day prednisone or equivalent and unchanged
• •Patients capable of reproduction and male patients who have partners capable of reproduction must agree to use an effective contraceptive method during the course of the study and for 2 months following the completion of their last treatment.
• •Females of childbearing potential must have a negative serum β-Hcg pregnancy test result within 7 days of first study dose. Female patients who are surgically sterilized or who are \> 45 years old and have not experienced menses for \> 2 years may have β- Hcg pregnancy test waived.
• •Required baseline laboratory data
• •Platelet count ≥ 75,000/mm3
• •Absolute neutrophil count (ANC) ≥ 1500/mm3
• •AST/ALT ≤ 2.5 times upper limit of normal (ULN)
• •Creatinine and total bilirubin ≤ 1.5 times ULN