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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


Phase 2
18 Years
60 Years
Not Enrolling
Both
Acute Myelogenous Leukemia

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

K-0009

NCT ID:

NCT00116467

Start Date:

March 2001

Completion Date:

January 2006

Related Keywords:

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

Name

Location

Johns Hopkins University Baltimore, Maryland  21205
University of California, San Francisco San Francisco, California  94143
Dana Farber Cancer Institute Boston, Massachusetts  02115
University of Chicago Chicago, Illinois  60637