AG-858 in Patients who are Cytogenetically Positive after Treatment with Gleevec™
This study is currently recruiting patients.
Sponsored by: |
Antigenics |
Information provided by: |
Antigenics |
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
|
Treatment or 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; Leukemia, Childhood
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:
Expected Total Enrollment:
40
Study start: March 2003
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 above,
Genders Eligible for Study:
Both
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
Location
and Contact
Information
Alabama Birmingham,
Alabama,
United States; Recruiting
California Los Angeles,
California,
United States; Recruiting
La Jolla,
California,
United States; Recruiting
Colorado Denver,
Colorado,
United States; Recruiting
Connecticut Farmington,
Connecticut,
United States; Recruiting
Illinois Chicago,
Illinois,
United States; Recruiting
Massachusetts Boston,
Massachusetts,
United States; Recruiting
Missouri St. Louis,
Missouri,
United States; Recruiting
New York New York City,
New York,
United States; Recruiting
Oregon Portland,
Oregon,
United States; Recruiting
Pennsylvania Pittsburgh,
Pennsylvania,
United States; Recruiting
United Kingdom London,
United Kingdom; Recruiting
Liverpool,
United Kingdom; Recruiting
More Information
For more information regarding Autologous HSP-70 Protein-Peptide Complex [AG-858], please visit Antigenics' internet site
For more information regarding Gleevec™, please visit Novartis' website
Study ID Numbers:
C-300-01
Record last reviewed:
July 2004
Record first received:
April 11, 2003
ClinicalTrials.gov Identifier:
NCT00058747Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-10-29