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| Sponsor: | Antigenics |
|---|---|
| Information provided by: | Antigenics |
| ClinicalTrials.gov Identifier: | NCT00058747 |
Purpose
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: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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™ |
| Estimated Enrollment: | 40 |
| Study Start Date: | March 2003 |
The goals of this study are to determine the following:
Eligibility| 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
Contacts and Locations| United States, Alabama | |
| Birmingham, Alabama, United States | |
| United States, California | |
| La Jolla, California, United States | |
| Los Angeles, 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 | |
| Liverpool, United Kingdom | |
| London, United Kingdom | |
More Information
| ClinicalTrials.gov Identifier: | NCT00058747 History of Changes |
| Obsolete Identifiers: | NCT00070395 |
| Other Study ID Numbers: | C-300-01 |
| Study First Received: | April 11, 2003 |
| Last Updated: | April 19, 2006 |
| 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 |
|
Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Neoplasms by Histologic Type Neoplasms Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases |
Imatinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |