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

2014-08-27 03:55:20 | BioPortfolio

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).

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.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Leukemia, Myeloid, Chronic

Intervention

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

Location

Birmingham
Alabama
United States

Status

Terminated

Source

Antigenics

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:55:20-0400

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