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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00058747
Recruitment Status : Terminated (Business decision of the sponsor)
First Posted : April 15, 2003
Last Update Posted : September 7, 2012
Information provided by (Responsible Party):
Agenus Inc.

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).

Condition or disease Intervention/treatment Phase
Leukemia, Myeloid, Chronic Drug: Autologous HSP-70 Protein-Peptide Complex (AG-858) Plus Gleevec™. Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2003
Actual Primary Completion Date : April 2006
Actual Study Completion Date : April 2006

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00058747

United States, Alabama
Birmingham, Alabama, United States
United States, California
La Jolla, California, United States
Los Angeles, 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
Liverpool, United Kingdom
London, United Kingdom
Sponsors and Collaborators
Agenus Inc.

Additional Information:
Responsible Party: Agenus Inc. Identifier: NCT00058747     History of Changes
Obsolete Identifiers: NCT00070395
Other Study ID Numbers: C-300-01
First Posted: April 15, 2003    Key Record Dates
Last Update Posted: September 7, 2012
Last Verified: September 2012

Keywords provided by Agenus Inc.:
Granulocytic Leukemia, Chronic
Leukemia, Granulocytic, Chronic
Leukemia, Myelocytic, Chronic
Leukemia, Myelogenous, Chronic
Myelocytic Leukemia, Chronic
Myelogenous Leukemia, Chronic
Myeloid Leukemia, Chronic

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action