Vaccination With GM-K562 Cells in Patients With Advanced Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML) After Allogeneic Hematopoetic 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 6th vaccine.

- 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.

Inclusion Criteria:

- Patients who have received an allogeneic bone marrow or peripheral blood stem cell
transplant for AML, meeting one of the following: 1) AML arising from MDS or MDP 2)AML
CR1 associated with high risk cytogenetics 3) AML transplanted in induction failure or
relapse 4) AML transplanted in second remission or beyond 5) AML in patient 60 years
or older

- Patients who have received an allogeneic bone marrow or peripheral blood stem cell
transplant for MDS-RAEB or CMML

- 18 years of age or older

- Donor is a related or unrelated donor who is at least 9/10 matched at HLA-A, B, C,
DRB1, and DQB1 by antigen level typing at class 1 and allele level typing at class II

- Recipients of myeloablative or reduced intensity conditioning transplants are eligible

- Patient must have sufficient autologous tumor cells banked at DFCI (on companion
tissue banking protocol) for vaccine generation prior to transplantation

- No active GVHD requiring systemic corticosteroid therapy

- No conditions requiring systemic corticosteroid therapy greater than or equal to 20mg
methylprednisolone or equivalent

- No uncontrolled infection

- Adequate hematopoietic engraftment with ANC >500 off growth factor support, and
platelet >10k without transfusion

- No non-hematologic toxicity of CTC Grade 3 or greater

- ECOG Performance Status 0-2

Exclusion Criteria:

- Recipients of cord blood transplant

- Patients with uncontrolled CNS disease

- Patients with relapsed/persistent disease after transplant who are expected to require
rapid withdrawal of immune suppression, cytoreductive therapy, or have a life
expectancy of < 3 months

- Concurrent participation in other transplant clinical trials where GVHD and/or disease
relapse are primary endpoints

- Patients deemed medically or psychologically unfit by treating physician or study
investigator