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

This study has been terminated.

Sponsored by: Antigenics
Information provided by: Antigenics
ClinicalTrials.gov Identifier: NCT00058747
  Purpose

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).


Condition Intervention Phase
Leukemia, Myeloid, Chronic
Drug: Autologous HSP-70 Protein-Peptide Complex (AG-858) Plus Gleevec™.
Phase II

MedlinePlus related topics:   Leukemia, Adult Acute    Leukemia, Adult Chronic   

ChemIDplus related topics:   Imatinib    Imatinib mesylate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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™

Further study details as provided by Antigenics:

Estimated Enrollment:   40
Study Start Date:   March 2003

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.
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00058747

Locations
United States, Alabama
      Birmingham, Alabama, United States
United States, California
      Los Angeles, California, United States
      La Jolla, California, United States
United States, Colorado
      Denver, Colorado, United States
United States, Connecticut
      Farmington, Connecticut, United States
United States, Illinois
      Chicago, Illinois, United States
United States, Massachusetts
      Boston, Massachusetts, United States
United States, Missouri
      St. Louis, Missouri, United States
United States, New York
      New York City, New York, United States
United States, Oregon
      Portland, Oregon, United States
United States, Pennsylvania
      Pittsburgh, Pennsylvania, United States
United Kingdom
      London, United Kingdom
      Liverpool, United Kingdom

Sponsors and Collaborators
Antigenics
  More Information


For more information regarding Autologous HSP-70 Protein-Peptide Complex [AG-858], please visit Antigenics' internet site  This link exits the ClinicalTrials.gov site
 
For more information regarding Gleevec™, please visit Novartis' website  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   C-300-01
First Received:   April 11, 2003
Last Updated:   April 19, 2006
ClinicalTrials.gov Identifier:   NCT00058747
Health Authority:   United States: Food and Drug Administration

Keywords provided by Antigenics:
Granulocytic Leukemia, Chronic  
Leukemia, Granulocytic, Chronic  
Leukemia, Myelocytic, Chronic  
Leukemia, Myelogenous, Chronic  
Myelocytic Leukemia, Chronic
Myelogenous Leukemia, Chronic
Myeloid Leukemia, Chronic

Study placed in the following topic categories:
Imatinib
Leukemia
Chronic myelogenous leukemia
Hematologic Diseases
Myeloproliferative Disorders
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Bone Marrow Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 07, 2008




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