Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Antigenics |
---|---|
Information provided by: | Antigenics |
ClinicalTrials.gov Identifier: | NCT00058747 |
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 | Intervention | Phase |
---|---|---|
Leukemia, Myeloid, Chronic |
Drug: Autologous HSP-70 Protein-Peptide Complex (AG-858) Plus Gleevec™. |
Phase II |
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™ |
Estimated Enrollment: | 40 |
Study Start Date: | March 2003 |
The goals of this study are to determine the following:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
(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
United States, Alabama | |
Birmingham, Alabama, United States | |
United States, California | |
Los Angeles, California, United States | |
La Jolla, California, United States | |
United States, Colorado | |
Denver, Colorado, United States | |
United States, Connecticut | |
Farmington, Connecticut, United States | |
United States, Illinois | |
Chicago, Illinois, United States | |
United States, Massachusetts | |
Boston, Massachusetts, United States | |
United States, Missouri | |
St. Louis, Missouri, United States | |
United States, New York | |
New York City, New York, United States | |
United States, Oregon | |
Portland, Oregon, United States | |
United States, Pennsylvania | |
Pittsburgh, Pennsylvania, United States | |
United Kingdom | |
London, United Kingdom | |
Liverpool, United Kingdom |
Study ID Numbers: | C-300-01 |
Study First Received: | April 11, 2003 |
Last Updated: | April 19, 2006 |
ClinicalTrials.gov Identifier: | NCT00058747 |
Health Authority: | United States: Food and Drug Administration |
Granulocytic Leukemia, Chronic Leukemia, Granulocytic, Chronic Leukemia, Myelocytic, Chronic Leukemia, Myelogenous, Chronic |
Myelocytic Leukemia, Chronic Myelogenous Leukemia, Chronic Myeloid Leukemia, Chronic |
Imatinib Leukemia Chronic myelogenous leukemia Hematologic Diseases |
Myeloproliferative Disorders Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Bone Marrow Diseases |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |