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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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™

Conditions
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Leukemia, Myeloid, Chronic

Intervention / Treatment
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* Drug: Autologous HSP-70 Protein-Peptide Complex (AG-858) Plus Gleevec™.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be Philadelphia chromosome positive chronic myelogenous leukemia in first chronic phase Must have a complete hematologic response Must have received Gleevec™, IFN-α, cytarabine, busulfan, hydroxyurea, Homoharringtonine (HHT) or any combination thereof as long as the combination has been discontinued and the dosing of Gleevec™ has been stable for 6 months or greater Must have one of the following cytogenetic statuses: (A) Less than a CCR after receiving Gleevec™ for at least one year at a minimum dose of 400 mg/day. A stable dose of Gleevec™ must have been maintained for the last six months prior to eligibility testing OR (B) Stable cytogenetic status without CCR (no cytogenic response or progression) in three consecutive determinations over six months while on a stable dose of Gleevec™ (at a minimum of 400mg/day) for at least 6 months OR (C) Cytogenetic progression while on a stable dose of Gleevec™ (at a minimum dose of 400mg/day)for at least 2 consecutive evaluations at least one month apart ECOG performance score of 0 or 1 Must be at least 18 years old Not pregnant or breastfeeding and agree to use contraception during the course of the study No prior allogeneic bone marrow transplant or be candidates for curative BMT No immunodeficiency or other serious illness No current use of immunosuppressive medications No other cancer within the last five years, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Autologous HSP-70 Protein-Peptide Complex (AG-858) Plus Gleevec™.|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Granulocytic Leukemia, Chronic, Leukemia, Granulocytic, Chronic, Leukemia, Myelocytic, Chronic, Leukemia, Myelogenous, Chronic, Myelocytic Leukemia, Chronic, Myelogenous Leukemia, Chronic, Myeloid Leukemia, Chronic