NCT00116467

Brief Summary

The purpose of this study is to evaluate clinical and laboratory safety associated with the administration of GVAX leukemia vaccine and to determine the feasibility of generation of GVAX leukemia vaccine in subjects with acute myelogenous leukemia (AML).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2001

Longer than P75 for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

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, 2001

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 30, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

December 24, 2007

Status Verified

December 1, 2007

First QC Date

June 29, 2005

Last Update Submit

December 18, 2007

Conditions

Acute Myelogenous Leukemia

Keywords

AMLAcute Myelogenous LeukemiaGVAXVaccineStem Cell TransplantAutologous

Interventions

GVAX leukemia vaccine (therapeutic cellular vaccine, GM-CSF producing)BIOLOGICAL

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Initial diagnosis of de novo AML with no preexisting hematologic dysplasia for more than 3 months.
  • No prior therapy except leukapheresis or less than 72 hours of hydroxyurea.

You may not qualify if:

  • Prior myelodysplastic disorder, or treatment-related leukemia.
  • Prior myeloproliferative disease.
  • Acute promyelocytic leukemia (APL).
  • Prior chemotherapy for a malignant or nonmalignant disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21231, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • Borrello IM, Levitsky HI, Stock W, Sher D, Qin L, DeAngelo DJ, Alyea EP, Stone RM, Damon LE, Linker CA, Maslyar DJ, Hege KM. Granulocyte-macrophage colony-stimulating factor (GM-CSF)-secreting cellular immunotherapy in combination with autologous stem cell transplantation (ASCT) as postremission therapy for acute myeloid leukemia (AML). Blood. 2009 Aug 27;114(9):1736-45. doi: 10.1182/blood-2009-02-205278. Epub 2009 Jun 25.

    PMID: 19556425DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Design

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

Study Record Dates

First Submitted

June 29, 2005

First Posted

June 30, 2005

Study Start

March 1, 2001

Study Completion

January 1, 2006

Last Updated

December 24, 2007

Record last verified: 2007-12

Locations

US(4)