A Phase II Study of Decitabine For the Front-line Treatment of Older Patients With Acute Myeloid Leukemia
Phase 2
60 Years
N/A
60 Years
N/A
Not Enrolling
Both
Acute Myeloid Leukemia
Both
Acute Myeloid Leukemia
Trial Information
A Phase II Study of Decitabine For the Front-line Treatment of Older Patients With Acute Myeloid Leukemia
Inclusion Criteria:
1. A diagnosis of AML or transformed from myelodysplastic syndrome (MDS) within 2 weeks
of study enrollment.
2. Ineligible to receive intensive chemotherapy for their disease.
3. Have not received any chemotherapy within 4 weeks of study enrollment and must have
recovered from any treatment-related toxicities.
Exclusion Criteria:
1. Received previous treatment for AML.
2. Previously received Vidaza.
3. Received any other investigational agents within 30 days of first dose of study drug.
4. Uncontrolled intercurrent illness.
5. Had radiotherapy within 14 days prior to study enrollment.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Complete Response = Morphologic Complete Remission (mCR)
Outcome Time Frame:
1 year
Safety Issue:
No
Principal Investigator
Eisai US Medical Services
Investigator Role:
Study Director
Investigator Affiliation:
Eisai Inc.
Authority:
United States: Food and Drug Administration
Study ID:
DACO-017
NCT ID:
NCT00358644
Start Date:
March 2005
Completion Date:
December 2008
Related Keywords:
- Acute Myeloid Leukemia
- Acute Myeloid Leukemia
- AML
- Decitabine
- Dacogen
- MGI PHARMA, INC.
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
Name | Location |
|---|---|
| Fountain Valley, California 92708 | |
| Columbia, Missouri 65203 |
