Phase II Study of Low-Dose Intravenous Decitabine in Patients Aged > 60 Years With Acute Myeloid Leukemia Who Are Not Eligible for Standard Induction Chemotherapy
60 Years
N/A
Both
Acute Myeloid Leukemia
Trial Information
Phase II Study of Low-Dose Intravenous Decitabine in Patients Aged > 60 Years With Acute Myeloid Leukemia Who Are Not Eligible for Standard Induction Chemotherapy
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.
Inclusion Criteria:
- Patients older than 60 years with acute myeloid leukemia (> 30 % bone marrow blasts)
not qualifying for, or not consenting to, standard induction chemotherapy or
immediate allografting
- life expectancy > 3 months with successful treatment
- performance status ECOG 0, 1, 2
- age-adjusted normal cardiac, kidney, liver function (creatinine < 1.5 mg/dl unless
leukemia-related, total bilirubin < 2.0 of upper normal limits)
- patients with >50 000 leukocytes/µl in whom initial cytoreduction according to
protocol is effective
- written informed consent
Exclusion Criteria:
- AML of FAB subtype M3
- previous induction-type chemotherapy for MDS or AML
- previous treatment with Decitabine, 5-azacytidine or ATRA
- "low-dose" chemotherapy (e.g.hydroxyurea, cytosine arabinoside, melphalan) within 8
weeks prior to Decitabine treatment, except for cytoreduction of leukocytosis > 50
000/µl according to protocol - patients with > 50 000 leukocytes/µl in whom initial
cytoreduction according to protocol is ineffective
- treatment with cytokines within previous 4 weeks
- concomitant use of any other investigational drug
- other malignancy that is not in remission (previous chemotherapy for other
malignancies is not an exclusion criteria)
- cardiac insufficiency NYHA IV
- HIV infection
- other uncontrolled active infection
- psychiatric disorder that interferes with treatment
- known hypersensitivity to retinoids
- contact lenses
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
response rate (complete and partial remissions, antileukemic effect)
Outcome Time Frame:
after four treatment courses of Decitabine, after 6 months
Safety Issue:
No
Principal Investigator
Michael Lübbert, Prof Dr med
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Medical Center Freiburg - Dept. of Oncology/Hematoloy
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
00331
NCT ID:
NCT00866073
Start Date:
April 2003
Completion Date:
March 2009
Related Keywords:
- Acute Myeloid Leukemia
- AML
- Acute myeloid leukemia
- Decitabine
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
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