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)

• Status: Withdrawn
• Trial end date: 2011-06-01

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.

• Phase: Phase 1/Phase 2

Details

• Lead Sponsor: MedImmune LLC
• Treatments: Blinatumomab