Azacitidine in Treating Patients With Newly Diagnosed Previously Untreated or Secondary Acute Myeloid Leukemia Who Are Unsuitable For Intensive Chemotherapy
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||5-Azacytidine to Treat Acute Myeloid Leukemia in Elderly or Frail Patients Not Suitable for Intensive Chemotherapy. A Multicenter Phase II Trial.|
- 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). ]
|Study Start Date:||July 2008|
|Study Completion Date:||November 2012|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Experimental: Arm: 5-azacytidine
5-azacytidine 100 mg/m2/day s.c. on days 1-5 of a 28-day cycle.
100 mg/m2/day s.c. on days 1-5 of a 28-day cycle
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00739388
|Aarau, Switzerland, CH-5001|
|Baden, Switzerland, CH-5404|
|Basel, Switzerland, CH-4031|
|Oncology Institute of Southern Switzerland|
|Bellinzona, Switzerland, CH-6500|
|Bern, Switzerland, CH-3010|
|Biel, Switzerland, CH-2500|
|Centre Hospitalier Universitaire Vaudois|
|Lausanne, Switzerland, CH-1011|
|Luzerne, Switzerland, CH-6000|
|Kantonsspital - St. Gallen|
|St. Gallen, Switzerland, CH-9007|
|Hopitaux Universitaires de Geneve|
|Thonex-Geneve, Switzerland, CH-1226|
|Zurich, Switzerland, CH-8091|
|Study Chair:||Jakob Passweg, Prof||Hopitaux Universitaires de Geneve|
|Study Chair:||Sabine Blum, MD||Centre Hospitalier Universitaire Vaudois|