NCT00058747

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).

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2003

Typical duration for phase_2

Geographic Reach
2 countries

13 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 11, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 15, 2003

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

September 7, 2012

Status Verified

September 1, 2012

Enrollment Period

3.1 years

First QC Date

April 11, 2003

Last Update Submit

September 6, 2012

Conditions

Leukemia, Myeloid, Chronic

Keywords

Granulocytic Leukemia, ChronicLeukemia, Granulocytic, ChronicLeukemia, Myelocytic, ChronicLeukemia, Myelogenous, ChronicMyelocytic Leukemia, ChronicMyelogenous Leukemia, ChronicMyeloid Leukemia, Chronic

Interventions

Autologous HSP-70 Protein-Peptide Complex (AG-858) Plus Gleevec™.DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Unknown Facility

Birmingham, Alabama, United States

Location

Unknown Facility

La Jolla, California, United States

Location

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

Denver, Colorado, United States

Location

Unknown Facility

Farmington, Connecticut, United States

Location

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

Boston, Massachusetts, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Portland, Oregon, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, United States

Location

Unknown Facility

Liverpool, United Kingdom

Location

Unknown Facility

London, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2003

First Posted

April 15, 2003

Study Start

March 1, 2003

Primary Completion

April 1, 2006

Study Completion

April 1, 2006

Last Updated

September 7, 2012

Record last verified: 2012-09

Locations

US(11)GB(2)