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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 UniversityBaltimore, Maryland  21205
University of California, San FranciscoSan Francisco, California  94143
Dana Farber Cancer InstituteBoston, Massachusetts  02115
University of ChicagoChicago, Illinois  60637