A Phase 2 interventional study of Decitabine 15 mg/m2 i.v. in Acute Myeloid Leukemia, sponsored by University Hospital Freiburg. Completed at 8 sites in 2 countries. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2009-03-20.
Sponsored by University Hospital Freiburg · Phase 2, Interventional, and Treatment
This study is an open-label phase II trial to investigate the efficacy and toxicity of low-dose decitabine (5-aza-2'-deoxycytidine) in elderly patients with acute myeloid leukemia (AML) not eligible for aggressive induction chemotherapy. AML patients above the age of 60 years (no upper age limit) who have not previously received and are not eligible for, standard induction treatment of their disease will be eligible for this trial. Decitabine will be administered as a 3 hour infusion at 15 mg/m2 three times daily on three consecutive days (total dose 135 mg/m2). In all patients with > 20000 WBC/µl, this treatment will be repeated 1 week later. In patients with white blood cells exceeding 50 000/μl, decitabine treatment will be preceded by cytoreductive doses of hydroxyurea.
Hypothesis: If after 4 courses of Decitabine none out of 12 patients achieves a response (complete or partial remission, antileukemic effect), the protocol will be stopped. If at least one response is seen among the first 12 patients, 17 additional patients will be treated in an open, uncontrolled manner. If in 3 or more of these 29 patients a response is achieved, this treatment will be considered effective and will be studied further, otherwise it will be considered ineffective. At a preliminary analysis after recruitment of 29 patients, encouraging results (response rate, tolerability) are prompting continuation of recruitment, with a planned inclusion of at least 60 patients, until initiation of the planned large, controlled phase II follow-up trial. Unexpected toxicities will be carefully evaluated. 29 patients were needed for the first two steps of this phase II study, at least 60 patients are planned for the extension of the recruitment. Expected study duration for the first two steps was 15-20 months, with 35-40 months total when including the third step.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 238 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →University Hospital Freiburg is the lead sponsor of 91 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Decitabine 15 mg/m2 i.v. - single arm
Drug: Decitabine 15 mg/m2 i.v.
Decitabine at 15 mg/m2 i.v. x 3 hours, three times daily on three consecutive days
Also known as: Dacogen
response rate (complete and partial remissions, antileukemic effect)
Time frame: after four treatment courses of Decitabine, after 6 months
overall survival
Time frame: after 1 year
progression-free survival time
Time frame: after 1 year
toxicity of Decitabine (alone and in combination with all-trans retinoic acid)
Time frame: after 3-6 months
This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital Freiburg