Spots Global Cancer Trial Database for AG-858 in Patients Who Are Cytogenetically Positive After Treatment With Gleevec™

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Trial Identification

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

Official Title: 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™

Study ID: NCT00058747

Conditions

Leukemia, Myeloid, Chronic

Interventions

Autologous HSP-70 Protein-Peptide Complex (AG-858) Plus Gleevec™.

Study Description

Brief 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.