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
Sponsor study identifier
interventional
33
1 country
1
Study Start
November 2008
Actual (reported)Primary Completion
May 2011
Actual (reported)Study Completion
January 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2008
Actual (reported)December 15, 2008
Actual (reported)December 17, 2008
Actual (reported)May 2011
Actual (reported)January 2020
Actual (reported)To assess the safety of vaccination, as measured by vaccine related reactions and incidence of grade III-IV acute GVHD.
2 years
To assess the efficacy of vaccination with GM-K562/leukemia cell vaccine following allogeneic stem cell transplantation in this patient population.
2 years
To characterize the biologic responses and leukemia specific immune responses after vaccination with GM-K562/leukemia cell vaccine following allogeneic stem cell transplant.
2 years
Biological/Vaccine: GM-K562/leukemia cell vaccine Cultured cell line genetically changed to secrete GM-CSF mixed with irradiated leukemia cells obtained from the participant. A total of 6 vaccine will be given. Vaccines 1-3 will be given once a week. Vaccines 4-6 will be given every other week.
Cultured cell line genetically changed to secrete GM-CSF mixed with irradiated leukemia cells obtained from the participant. A total of 6 vaccine will be given. Vaccines 1-3 will be given once a week. Vaccines 4-6 will be given every other week.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Vincent Ho, MD
Dana-Farber Cancer Institute
33 participants (actual enrollment reported by the registry).
First Submitted
December 15, 2008
First Posted
December 17, 2008
Study Start
November 2008
Actual (reported)To determine duration of disease response, disease free and overall survival
2 years
Contact the study team to confirm eligibility.
Primary Completion
May 2011
Actual (reported)Study Completion
January 2020
Actual (reported)Last Updated
September 16, 2020
Record last verified: 2020-09
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Source: ClinicalTrials.gov.
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