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
- Participants will be given the GM-K562/Leukemia call vaccine as in injection under the
skin a total of six times. The first 3 vaccines will be given weekly and vaccines 4
through 6 will be given every other week. Therefore, it is expected that the vaccines
will be completed over a period of 9 weeks.
- During the 9 week vaccination period, participants will have physical exams to monitor
for any side effects or graft-versus-host disease (GVHD). Bone marrow biopsies will be
performed a the time of enrollment for this study, 4 weeks after completion of 6
GM-K562/Leukemia cell vaccines, and 1 year after the participants transplant.
- As a way of testing whether the GM-K562/Leukemia cell vaccine is triggering any immune
response to the participants leukemia, we will be injecting a small amount of leukemia
cells (after they are killed with radiation) under the participants skin to see if the
body will generate a reaction to the leukemia cells. This test is called a leukemia
cell delayed hypersensitivity test (DTH). This test will be performed three times
during the study, on the weeks of the 1st vaccine, 5th vaccine and 4 weeks after the
- There are a total of 5 skin biopsies required as part of this study. Biopsies will be
taken from the vaccination sites 2-3 days after the first and fifth vaccine. Similar
biopsies will be taken from the DTH sites after the 1st vaccination, 5th vaccination
and 4-6 weeks after the 6th vaccination.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the safety of vaccination, as measured by vaccine related reactions and incidence of grade III-IV acute GVHD.
Vincent Ho, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|