NCT00058747

AG-858 in Patients Who Are Cytogenetically Positive After Treatment With Gleevec™

Phase II Exploratory Study Of AG-858 Plus Gleevec™ In Patients With Chronic Myelogenous Leukemia (CML) In Chronic Phase Who Are Cytogenetically Positive After Treatment With Gleevec™

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (planned)
• Sponsor: Agenus Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II, exploratory, open-label study of the investigational product AG-858, in patients who are cytogenetically positive after treatment with Gleevec. The trial will consist of three independent Phase II evaluations of patient groups according to their cytogenetic status as defined in the eligibility criteria (Eligibility Criteria 4a, 4b, and 4c).

Detailed description

The goals of this study are to determine the following: * To estimate the proportion of patients with a complete cytogenetic response (CCR) within each patient group * To estimate the proportion of patients with a substantial molecular response (SMR) within each patient group * To evaluate the frequency and severity of adverse events. * To assess the feasibility of AG-858 production.

Conditions

• Leukemia, Myeloid, Chronic

Interventions

Type	Name	Description
DRUG	Autologous HSP-70 Protein-Peptide Complex (AG-858) Plus Gleevec™.

Timeline

• Start date: 2003-03-01
• Primary completion: 2006-04-01
• Completion: 2006-04-01
• First posted: 2003-04-15
• Last updated: 2012-09-07

Locations

13 sites across 2 countries: United States, United Kingdom