A Phase 1/1b Study of TRU-016 in Patients With Previously Treated Chronic Lymphocytic Leukemia or Select Subtypes of 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
- SGOT, SGPT
- 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
- Platelets
- Previous or concurrent additional malignancy

- Significant concurrent medical diseases or conditions

- Hepatitis B surface antigen or hepatitis B core antibody positive

- Pregnant or breastfeeding