Phase 1/1b Study of TRU-016 in Patients With Previously Treated CLL or Select Subtypes of Non-Hodgkin's Lymphoma

A Phase 1/1b Study of TRU-016 in Patients With Previously Treated Chronic Lymphocytic Leukemia or Select Subtypes of Non-Hodgkin's Lymphoma

The purpose of this study is to evaluate the safety and tolerability of TRU-016 in patients with previously treated chronic lymphocytic leukemia, and to obtain an estimate of clinical activity in patients with CLL and non-Hodgkin's lymphoma.

This Phase 1/1b open-label study consists of two parts. The initial portion is a Phase 1 dose-escalation study evaluating the safety and tolerability of TRU-016 administered over a 4-week period to patients with relapsed chronic lymphocytic leukemia (CLL). It will identify the MTD and evaluate the pharmacokinetics and immunogenicity of TRU-016. Upon demonstrating satisfactory safety and tolerability in the Phase 1 portion, a Phase 1b expansion cohort will be enrolled to further characterize the safety of the selected dose from the first stage of the study and safety and to estimate the clinical activity of TRU-016 in patients with treatment-naive CLL, relapsed CLL and non-Hodgkin's lymphoma.

Inclusion Criteria:

• Diagnosis of chronic lymphocytic lymphoma or small lymphocytic lymphoma (Phase 1) or relapsed/refractory NHL (Phase 1b)

• Previous treatment with at least one fludarabine-containing regimen

• Demonstrate at least one of the following criteria for active disease requiring treatment:

  • a)progressive splenomegaly and/or lymphadenopathy;
  • b)anemia or thrombocytopenia due to bone marrow involvement;
  • c)unintentional weight loss >10% over preceding 6-month period;
  • d) NCI Grade 2 or 3 fatigue;
  • e) fevers >100.5 F or night sweats for > 2 weeks without infection;
  • f) progressive lymphocytosis with increase of >50% over a 2-month period or anticipated doubling time of < 6 months.

• ECOG performance status </= 2

• SGOT, SGPT </= 2.0 x upper limit of normal

• ANC >/= 500/uL

• Platelets >/= 30,000/uL

• Discontinued previous anticancer or investigational therapy for at least 30 days

Exclusion Criteria:

• Treatment with rituximab within 30 days or alemtuzumab(Campath)or radioimmune therapy within 12 weeks
• ANC </= 500/uL
• Platelets </= 30,000/mm3
• Previous or concurrent additional malignancy
• Significant concurrent medical diseases or conditions
• Hepatitis B surface antigen or hepatitis B core antibody positive
• Pregnant or breastfeeding