MedDataX Logo

Vaccination in the Peripheral Stem Cell Transplant Setting for Acute Myelogenous Leukemia

NCT ID: NCT00116467

Last Updated: 2007-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-03-31

Study Completion Date

2006-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Myelogenous Leukemia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

AML Acute Myelogenous Leukemia GVAX Vaccine Stem Cell Transplant Autologous

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

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

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cell Genesys

INDUSTRY

Sponsor Role lead

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of California, San Francisco

San Francisco, California, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 19556425 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

K-0009

Identifier Type: -

Identifier Source: secondary_id

K-0009

Identifier Type: -

Identifier Source: org_study_id