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Sponsors and Collaborators: |
Dana-Farber Cancer Institute Brigham and Women's Hospital National Institutes of Health (NIH) |
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Information provided by: | Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00809250 |
The purpose of this research study is to determine if the GM-K562/leukemia cell vaccine can be safely given soon after allogeneic marrow or blood stem cell transplant. The GM-K562/leukemia cell vaccine is composed of a cultured cell line that has been genetically modified to secrete GM-CSF, a naturally occuring substance in the body that stimulates the immune system. The vaccine is a mixture of the GM-K562 cells (radiated to prevent them from growing in the participants body) with the participant's previously frozen and killed leukemia cells. By mixing the GM-K562 with the leukemia cells, we would like to study whether this vaccine combination will stimulate the participant's new immune system to recognize and fight against their MDS/AML cancer cells.
Condition | Intervention | Phase |
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Acute Myeloid Leukemia Chronic Myelomonocytic Leukemia Myelodysplastic Syndrome-Refractory Anemia With Excess Blasts |
Biological: GM-K562/leukemia cell vaccine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
Official Title: | Vaccination With Lethally Irradiated Autologous Myeloblasts With Granulocyte Macrophage-Colony Stimulating Factor Secreting K562 Cells (GM-K562) in Patients With Advanced MDS or AML After Allogeneic Hematopoietic Stem Cell Transplantation |
Estimated Enrollment: | 40 |
Study Start Date: | November 2008 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Vincent Ho, MD | 617-632-5938 |
United States, Massachusetts | |
Dana-Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Vincent Ho, MD | Dana-Farber Cancer Institute |
Responsible Party: | Dana-Farber Cancer Institute ( Vincent Ho, MD ) |
Study ID Numbers: | 08-160 |
Study First Received: | December 15, 2008 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00809250 |
Health Authority: | United States: Food and Drug Administration |
vaccination AML CMML MDS-RAEB |
Myelodysplastic syndromes Precancerous Conditions Chronic myelomonocytic leukemia Refractory anemia Hematologic Diseases Leukemia, Myelomonocytic, Chronic Myelodysplasia Myelodysplastic Syndromes Acute myelogenous leukemia Anemia Myeloproliferative Disorders |
Leukemia, Myeloid Leukemia, Myeloid, Acute Leukemia, Myelomonocytic, Acute Myelodysplastic myeloproliferative disease Leukemia Preleukemia Anemia, Refractory Anemia, Refractory, with Excess of Blasts Myelodysplastic-Myeloproliferative Diseases Bone Marrow Diseases Acute myelocytic leukemia |
Neoplasms Pathologic Processes Disease Neoplasms by Histologic Type Syndrome |