A Study to Evaluate the Safety, Tolerability, and Antitumor Activity of Continuous Intravenous Infusion of MEDI-538 in Adults With B-Cell Chronic Lymphocytic Leukemia (CLL)

Summary

Phase 1: * Evaluate the safety and tolerability of MEDI-538 given by escalated doses with continuous IV infusion for 4 weeks in adult patients with CLL. * Determine the maximum tolerated dose (MTD) of MEDI-538 administered by continuous IV infusion for 4 weeks in this patient population * Describe the pharmacokinetics (PK) of MEDI-538 * Describe the immunogenicity (IM) of MEDI-538 * Determine the overall response, which is defined as follows: (1) conversion from PD/SD to PR/nPR/CR or conversion from PR to nPR/CR using standard NCI-WG criteria; or (2) conversion from MRD positivity to MRD negativity using 4-color flow cytometry; and * Describe any antitumor activity (ie, time to response and duration of response) of MEDI-538 in this patient population. Phase 2: * To determine the overall response in adult patients with CLL who have residual disease following previous therapy for CLL. * Describe the safety,PK,and IM of MEDI-538 * Determine the time to MRD relapse * Determine the antitumor activity (ie, time to response, duration of response,and time to progression \[TTP\])of MEDI-538 in this patient population.

Timeline

Start

2008-06

Primary completion

2010-03

Completion

2011-06

Drugs

Indications