Phase 1/1b Study of TRU-016 in Patients With Previously Treated CLL 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 \</= 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