Know Cancer

or
forgot password

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


Phase 1
18 Years
N/A
Not Enrolling
Both
Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome-Refractory Anemia With Excess Blasts

Thank you

Trial Information

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
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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the safety of vaccination, as measured by vaccine related reactions and incidence of grade III-IV acute GVHD.

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Vincent Ho, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

08-160

NCT ID:

NCT00809250

Start Date:

November 2008

Completion Date:

December 2026

Related Keywords:

  • Acute Myeloid Leukemia
  • Chronic Myelomonocytic Leukemia
  • Myelodysplastic Syndrome-Refractory Anemia With Excess Blasts
  • vaccination
  • AML
  • CMML
  • MDS-RAEB
  • Anemia
  • Anemia, Refractory
  • Anemia, Refractory, with Excess of Blasts
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelomonocytic, Chronic
  • Myelodysplastic Syndromes
  • Preleukemia
  • Leukemia, Myelomonocytic, Acute

Name

Location

Dana-Farber Cancer Institute Boston, Massachusetts  02115