Spots Global Cancer Trial Database for Azacitidine in Treating Patients With Newly Diagnosed Previously Untreated or Secondary Acute Myeloid Leukemia Who Are Unsuitable For Intensive Chemotherapy

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Trial Identification

Brief Title: Azacitidine in Treating Patients With Newly Diagnosed Previously Untreated or Secondary Acute Myeloid Leukemia Who Are Unsuitable For Intensive Chemotherapy

Official Title: 5-Azacytidine to Treat Acute Myeloid Leukemia in Elderly or Frail Patients Not Suitable for Intensive Chemotherapy. A Multicenter Phase II Trial.

Study ID: NCT00739388

Conditions

Leukemia

Interventions

azacytidine

Study Description

Brief Summary: 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.

Detailed Description: 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.