A Phase 2 interventional study of azacytidine in Leukemia, sponsored by Swiss Group for Clinical Cancer Research. Completed at 11 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-04-10.
Sponsored by Swiss Group for Clinical Cancer Research · Phase 2, Interventional, and Treatment
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
Secondary
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.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 47 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →Swiss Group for Clinical Cancer Research is the lead sponsor of 107 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
Must be considered unsuitable for intensive chemotherapy due to ≥ 1 of the following:
PATIENT CHARACTERISTICS:
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:
PRIOR CONCURRENT THERAPY:
5-azacytidine 100 mg/m2/day s.c. on days 1-5 of a 28-day cycle.
Drug: azacytidine
100 mg/m2/day s.c. on days 1-5 of a 28-day cycle
Also known as: Azacitidine, 5-azacytidine, Vidaza
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).
This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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Swiss Group for Clinical Cancer Research