5-Azacytidine to Treat Acute Myeloid Leukemia in Elderly or Frail Patients Not Suitable for Intensive Chemotherapy. A Multicenter Phase II Trial.
- To evaluate the efficacy of azacitidine in patients with newly diagnosed or untreated
acute myeloid leukemia who are unsuitable for induction type chemotherapy because of
age or relevant comorbidities.
- To evaluate survival and adverse events.
OUTLINE: This is a multicenter study.
Patients receive azacitidine subcutaneously on days 1-5. Treatment repeats every 28 days for
6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year and
then every 6 months for 1 year.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Best response (complete or partial response)
within 6 months
Jakob Passweg, Prof
Hopitaux Universitaires de Geneve