Vaccination With GM-K562 Cells in Patients With Advanced Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML) After Allogeneic Hematopoetic Stem Cell Transplantation

Completed · Phase 1

Conditions studied: Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome-Refractory Anemia With Excess Blasts

In brief

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.

Key facts

Study ID

NCT00809250

Run by

Dana-Farber Cancer Institute

People needed

33

Starts

2008-11-01

Expected to finish

2020-01-01

Last updated by the study team

2020-09-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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