Azacitidine in Treating Patients With Newly Diagnosed Previously Untreated or Secondary Acute Myeloid Leukemia Who Are Unsuitable For Intensive Chemotherapy
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|ClinicalTrials.gov Identifier: NCT00739388|
Recruitment Status : Completed
First Posted : August 21, 2008
Last Update Posted : April 10, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: azacytidine||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||July 2008|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||November 2012|
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
- 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). ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|