Study of Vaccination With Autologous Acute Myeloblastic Leukemia Cells in Patients With Advanced Myelodysplasia or Acute Myelogenous Leukemia
Acute Myelogenous Leukemia, Myelodysplasia
About this trial
This is an interventional prevention trial for Acute Myelogenous Leukemia focused on measuring AML, acute myelogenous leukemia, MDS, myelodysplasia, vaccine
Eligibility Criteria
Inclusion Criteria: Patients must have pathologically documented myelodysplasia or acute myelogenous leukemia. The patients with myelodysplasia must also have: French-American-British (FAB) subtype refractory anemia with excess blasts (RAEB) or refractory anemia with excess blasts in transformation (RAEB-T), or normal or hypercellular bone marrow. The patients with acute myelogenous leukemia must also: not be candidates for myelosuppressive chemotherapy due to age or comorbid disease, or have relapsed acute myelogenous leukemia or be refractory to standard therapy and not likely to require cytoreductive therapy within 60 days Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. Estimated life expectancy of 6 months or greater. Age at least 18 years. Greater than 4 weeks from any chemotherapy, radiotherapy, immunotherapy, or systemic glucocorticoid therapy (non-glucocorticoid hormonal therapy allowed). Greater than 2 months following bone marrow or peripheral blood stem cell transplantation or treatment with donor lymphocyte infusion (DLI). Exclusion Criteria: Uncontrolled active infection. Pregnancy or nursing mothers. Previous participation in an adenovirus based trial. The patients with myelodysplasia who have either: FAB subtype refractory anemia (RA), refractory anemia with ringed sideroblasts (RARS), chronic myelomonocytic leukemia (CMML), or the presence of hypocellular bone marrow. Chemotherapy, radiotherapy, immunotherapy, or systemic steroid therapy within the last 4 weeks. Active central nervous system (CNS) disease. Evidence of infection with the human immunodeficiency virus. Active psychiatric or mental illness making informed consent or careful clinical follow-up unlikely.
Sites / Locations
- Dana-Farber Cancer Institute