Study of Vaccination With Autologous Acute Myeloblastic Leukemia Cells in Patients With Advanced Myelodysplasia or Acute Myelogenous Leukemia

Completed · Phase 1

Conditions studied: Acute Myelogenous Leukemia, Myelodysplasia

In brief

The purpose of this study is to test the safety of a new investigational acute myeloblastic leukemia (AML) vaccine and see what effects (good and bad) it has on patients with advanced myelodysplasia or acute myelogenous leukemia.

Key facts

Study ID

NCT00136422

Run by

Dana-Farber Cancer Institute

People needed

30

Starts

2000-01-01

Expected to finish

2006-03-01

Last updated by the study team

2011-03-10

Who can join

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

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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