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

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aptevo Therapeutics
• Treatments: Immunoglobulin G

Criteria

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