Overview

Combination Veltuzumab and Fractionated 90Y- Epratuzumab Radioimmunotherapy in Follicular Lymphoma

Status:
Terminated
Trial end date:
2015-07-31
Target enrollment:
Participant gender:
Summary
A Phase I/II clinical trial using a fractionated dosing regimen of 90Y-epratuzumab (anti-CD22) has showed encouraging responses in follicular and aggressive NHL with an ability to administer safely 2 injections of 20 mCi/m2 spaced 1 week apart. The investigators propose to combine this active 90Y-epratuzumab treatment with a regimen of veltuzumab that was also found active in Phase I/II trials. The goal of this study is to determine the safety and efficacy of 90Y-epratuzumab when used in combination with veltuzumab. The primary objective is to determine the response rate of this combination treatment. Secondary objectives are to assess safety, pharmacokinetics and targeting of 90Y-epratuzumab . Veltuzumab blood levels and anti-antibody responses will also be monitored at various times.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Weill Medical College of Cornell University
Collaborators:
Gilead Sciences
Immunomedics, Inc.
Treatments:
1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid
Epratuzumab
Veltuzumab