• Time to response [ Designated as safety issue: No ]
• Response duration [ Designated as safety issue: No ]
• Best response status within 6 months [ Designated as safety issue: No ]
• Time to hematological improvement (HI) [ Designated as safety issue: No ]
• Duration of HI [ Designated as safety issue: No ]
• Event-free survival [ Designated as safety issue: No ]
• Overall survival [ Designated as safety issue: No ]
• Adverse events according to NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
• Adjusted hospitalization time [ Designated as safety issue: No ]

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.

DISEASE CHARACTERISTICS:

• Diagnosis of 1 of the following:

  • De novo acute myeloid leukemia (AML)
  • AML secondary to prior hematological disease or cytotoxic treatment
• Newly diagnosed or untreated disease
• At least 20% blasts in the blood or bone marrow or extramedullary disease

• Must be considered unsuitable for intensive chemotherapy due to ≥ 1 of the following:

  • High age or frail for the biologic age
  • Relevant comorbidities
  • Unwilling to undergo intensive chemotherapy
• No chronic myelogenous leukemia or acute promyelocytic leukemia

PATIENT CHARACTERISTICS:

• WHO performance status 0-3
• Bilirubin ≤ 3 times upper limit of normal (ULN)
• Alkaline phosphatase ≤ 2.5 times ULN
• AST ≤ 2.5 times ULN
• Serum creatinine ≤ 2.5 times ULN
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 12 months after completion of study treatment
• Patient compliance and geographic proximity allow proper staging and follow-up
• No NYHA class III-IV heart failure or relevant cardiac arrhythmia
• No active hematological/oncological disease other than AML
• No psychiatric disorder precluding understanding of information on trial related topics or giving informed consent

• No serious underlying medical condition in the judgment of the investigator, which could impair the ability of the patient to participate in the trial, including but not limited to, any of the following:

  • Active autoimmune disease
  • Uncontrolled diabetes
  • Active uncontrolled infection
  • HIV infection
  • Active chronic hepatitis B or C infection
• No known allergy or hypersensitivity to azacitidine or mannitol

PRIOR CONCURRENT THERAPY:

• No prior treatment for AML
• No prior azacitidine or decitabine
• No other concurrent experimental or investigational drugs or anticancer therapy
• More than 30 days since participation in another clinical trial
• No concurrent growth factors for use in afebrile and asymptomatic patients except to treat neutropenic infection