Status:
COMPLETED
Vaccination With GM-K562 Cells in Patients With Advanced Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML) After Allogeneic Hematopoetic Stem Cell Transplantation
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
National Institutes of Health (NIH)
Conditions:
Acute Myeloid Leukemia
Chronic Myelomonocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 vaccin...
Detailed Description
* 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 eve...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2020
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00809250
Start Date
November 1 2008
End Date
January 1 2020
Last Update
September 16 2020
Active Locations (1)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115