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

Vaccination in the Peripheral Stem Cell Transplant Setting for Acute Myelogenous Leukemia: The Use of Autologous Tumor Cells With an Allogeneic GM-CSF Producing Cell Line

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00116467

Enrollment

Registered

2005-06-30

Start date

2001-03-31

Completion date

2006-01-31

Last updated

2007-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myelogenous Leukemia

Keywords

AML, Acute Myelogenous Leukemia, GVAX, Vaccine, Stem Cell Transplant, Autologous

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).

Interventions

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026