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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
100 mg/m2/day s.c. on days 1-5 of a 28-day cycle
Kantonspital Aarau
Aarau, Switzerland
Kantonsspital Baden
Baden, Switzerland
Universitaetsspital-Basel
Basel, Switzerland
Oncology Institute of Southern Switzerland
Best response (complete or partial response)
Time frame: within 6 months
Time to response
Time frame: is defined as the time from trial registration until the date the criteria for either CR or PR are first met
Response duration
Time frame: is defined as the time from the date when the criteria for either CR or PR were first met until the date of relapse or death from any cause.
Best response status
Time frame: within 6 months
Time to hematological improvement (HI)
Time frame: is calculated for patients with HI and is defined as the time from trial registration until the date the criteria for HI are first met.
Duration of HI
Time frame: is defined as the time from the date when the criteria for HI were first met until the date of relapse or death from any cause.
Event-free survival
Time frame: is defined as the time from trial registration until progression, relapse or death from any cause, whichever occurs first.
Overall survival
Time frame: is defined as the time from trial registration until death from any cause.
Adverse events according to NCI CTCAE v3.0
Time frame: according to NCI CTCAE v3.0
Adjusted hospitalization time
Time frame: is defined as the time (nights) spent in hospital as a proportion of treatment duration (days).
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Bellinzona, Switzerland
Inselspital Bern
Bern, Switzerland
Spitalzentrum Biel
Biel, Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
Kantonsspital, Luzerne
Luzerne, Switzerland
Kantonsspital - St. Gallen
Sankt Gallen, Switzerland
Hopitaux Universitaires de Geneve
Thonex-Geneve, Switzerland
...and 1 more locations