AG-858 in Patients Who Are Cytogenetically Positive After Treatment With Gleevec™
This study has been terminated.
(Business decision of the sponsor)
Sponsor:
Agenus, Inc.
Information provided by (Responsible Party):
Agenus, Inc.
ClinicalTrials.gov Identifier:
NCT00058747
First received: April 11, 2003
Last updated: September 6, 2012
Last verified: September 2012
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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 2 |
| 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™ |
Resource links provided by NLM:
Further study details as provided by Agenus, Inc.:
| Estimated Enrollment: | 40 |
| Study Start Date: | March 2003 |
| Study Completion Date: | April 2006 |
| Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00058747
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 | |
Sponsors and Collaborators
Agenus, Inc.
More Information
Additional Information:
No publications provided
| Responsible Party: | Agenus, Inc. |
| 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: | September 6, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Agenus, Inc.:
|
Granulocytic Leukemia, Chronic Leukemia, Granulocytic, Chronic Leukemia, Myelocytic, Chronic Leukemia, Myelogenous, Chronic |
Myelocytic Leukemia, Chronic Myelogenous Leukemia, Chronic Myeloid Leukemia, Chronic |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on June 17, 2013