Status:
COMPLETED
Study of Low-Dose Intravenous Decitabine in Patients Aged > 60 Years With Acute Myeloid Leukemia
Lead Sponsor:
University Hospital Freiburg
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief Summary
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 f...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT00866073
Start Date
April 1 2003
End Date
March 1 2009
Last Update
March 20 2009
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany, 30625
2
Klinikum der Technischen Universität Aachen
Aachen, Germany
3
Universitätsklinikum Düsseldorf
Düsseldorf, Germany
4
Katholisches Krankenhaus Hagen
Hagen, Germany