AG-858 in Patients Who Are Cytogenetically Positive After Treatment With Gleevec™
NCT ID: NCT00058747
Last Updated: 2012-09-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
40 participants
INTERVENTIONAL
2003-03-31
2006-04-30
Brief Summary
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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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* 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
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Autologous HSP-70 Protein-Peptide Complex (AG-858) Plus Gleevec™.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Agenus Inc.
INDUSTRY
Responsible Party
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Locations
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Birmingham, Alabama, United States
La Jolla, California, United States
Los Angeles, California, United States
Denver, Colorado, United States
Farmington, Connecticut, United States
Chicago, Illinois, United States
Boston, Massachusetts, United States
St Louis, Missouri, United States
New York, New York, United States
Portland, Oregon, United States
Pittsburgh, Pennsylvania, United States
Liverpool, , United Kingdom
London, , United Kingdom
Countries
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Related Links
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For more information regarding Gleevec™, please visit Novartis' website
Other Identifiers
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C-300-01
Identifier Type: -
Identifier Source: org_study_id
NCT00070395
Identifier Type: -
Identifier Source: nct_alias