NCT00614042

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Aptevo Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Chronic Lymphocytic Leukemia (CLL)
• Non-Hodgkin's Lymphoma (NHL)

Interventions

Type	Name	Description
DRUG	TRU-016 (anti-CD37 protein therapeutic)	TRU-016 administered via IV infusion weekly for 8 weeks and then monthly

Timeline

• Start date: 2008-01-01
• Primary completion: 2011-12-01
• Completion: 2012-03-01
• First posted: 2008-02-13
• Last updated: 2017-06-28

Locations

7 sites across 1 country: United States