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

Stopped early · Phase 2

Conditions studied: Leukemia, Myeloid, Chronic

In brief

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).

Key facts

Study ID

NCT00058747

Run by

Agenus Inc.

People needed

40

Starts

2003-03-01

Expected to finish

2006-04-01

Last updated by the study team

2012-09-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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