Clinical trial NCT00058747: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: 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
Lead sponsor: Agenus Inc.
Sponsor class: INDUSTRY
First posted: 2003-04-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: La Jolla
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Farmington
country: United States
state: Connecticut
city: Chicago
country: United States
state: Illinois
city: Boston
country: United States
state: Massachusetts
city: St. Louis
country: United States
state: Missouri
city: New York City
country: United States
state: New York
city: Portland
country: United States
state: Oregon
city: Pittsburgh
country: United States
state: Pennsylvania
city: Liverpool
country: United Kingdom
city: London
country: United Kingdom
Study officials:
References: