Leukemia Clinical Trial
Official title:
5-Azacytidine to Treat Acute Myeloid Leukemia in Elderly or Frail Patients Not Suitable for Intensive Chemotherapy. A Multicenter Phase II Trial.
RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop
the growth of cancer cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well azacitidine works in treating patients
with acute myeloid leukemia who are unsuitable for treatment with intensive chemotherapy.
OBJECTIVES:
Primary
- 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.
Secondary
- 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
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