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

Sponsor

Agenus Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT00058747

Collaborator

(none)

Enrollment

Locations

Duration (Months)

3.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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).

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 Design

Study Type:

Interventional

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 :

Mar 1, 2003

Actual Primary Completion Date :

Apr 1, 2006

Actual Study Completion Date :

Apr 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	City	State	Country
1	Birmingham	Alabama	United States
2	La Jolla	California	United States
3	Los Angeles	California	United States
4	Denver	Colorado	United States
5	Farmington	Connecticut	United States
6	Chicago	Illinois	United States
7	Boston	Massachusetts	United States
8	St. Louis	Missouri	United States
9	New York City	New York	United States
10	Portland	Oregon	United States
11	Pittsburgh	Pennsylvania	United States
12	Liverpool		United Kingdom
13	London		United Kingdom