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

Primary Purpose

Leukemia, Myeloid, Chronic

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Autologous HSP-70 Protein-Peptide Complex (AG-858) Plus Gleevec™.
Sponsored by
Agenus Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia, Myeloid, Chronic focused on measuring Granulocytic Leukemia, Chronic, Leukemia, Granulocytic, Chronic, Leukemia, Myelocytic, Chronic, Leukemia, Myelogenous, Chronic, Myelocytic Leukemia, Chronic, Myelogenous Leukemia, Chronic, Myeloid Leukemia, Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 11, 2003
Last Updated
September 6, 2012
Sponsor
Agenus Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00058747
Brief Title
AG-858 in Patients Who Are Cytogenetically Positive After Treatment With Gleevec™
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 Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Terminated
Why Stopped
Business decision of the sponsor
Study Start Date
March 2003 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Agenus Inc.

4. Oversight

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myeloid, Chronic
Keywords
Granulocytic Leukemia, Chronic, Leukemia, Granulocytic, Chronic, Leukemia, Myelocytic, Chronic, Leukemia, Myelogenous, Chronic, Myelocytic Leukemia, Chronic, Myelogenous Leukemia, Chronic, Myeloid Leukemia, Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Autologous HSP-70 Protein-Peptide Complex (AG-858) Plus Gleevec™.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
La Jolla
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Denver
State/Province
Colorado
Country
United States
City
Farmington
State/Province
Connecticut
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
St. Louis
State/Province
Missouri
Country
United States
City
New York City
State/Province
New York
Country
United States
City
Portland
State/Province
Oregon
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
City
Liverpool
Country
United Kingdom
City
London
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.novartis.com
Description
For more information regarding Gleevec™, please visit Novartis' website

Learn more about this trial

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

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