AG-858 in Patients Who Are Cytogenetically Positive After Treatment With Gleevec™

This study has been terminated.

(Business decision of the sponsor)

Sponsor:

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

History of Changes

Tracking Information
First Received Date ^ICMJE	April 11, 2003
Last Updated Date	September 6, 2012
Start Date ^ICMJE	March 2003
Primary Completion Date	April 2006 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00058747 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	AG-858 in Patients Who Are Cytogenetically Positive After Treatment With Gleevec™
Official Title ^ICMJE	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™
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Leukemia, Myeloid, Chronic
Intervention ^ICMJE	Drug: Autologous HSP-70 Protein-Peptide Complex (AG-858) Plus Gleevec™.
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	40
Completion Date	April 2006
Primary Completion Date	April 2006 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT00058747
Other Study ID Numbers ^ICMJE	C-300-01
Has Data Monitoring Committee	Not Provided
Responsible Party	Agenus, Inc.
Study Sponsor ^ICMJE	Agenus, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Agenus, Inc.
Verification Date	September 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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