Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Agenus Inc.
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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
Clareo Health | AG-858 in Patients Who Are Cytogenetically Positive After Treatment With Gleevec™
