Randomized Phase 3 Trial of Decitabine Versus Patient's Choice With Physician's Advice of Either Supportive Care or Low-Dose Cytarabine for the Treatment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia
65 Years
N/A
Both
Acute Myeloid Leukemia
Trial Information
Randomized Phase 3 Trial of Decitabine Versus Patient's Choice With Physician's Advice of Either Supportive Care or Low-Dose Cytarabine for the Treatment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia
Inclusion Criteria:
1. Must have diagnosed acute myeloid leukemia.
2. Must have a life expectancy of at least 12 weeks.
3. Must sign informed consent.
Exclusion Criteria:
1. Must not have acute promyelocytic leukemia (M3 classification)
2. Must not have any other active systemic malignancies.
3. Must not have inaspirable bone marrow.
4. Must not have received previous chemotherapy (except hydroxyurea) for any myeloid
disorder.
5. Must not have chronic respiratory disease that requires continuous oxygen use.
6. Must not have received any experimental drug within 4 weeks before randomization.
7. Must not be a candidate for a bone marrow or stem cell transplant within 12 weeks
after randomization.
8. Must not have known HIV.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall Survival in Patients 65 Years or Older Who Have Newly Diagnosed de Novo or Secondary AML.
Outcome Description:
The interval from date of randomization to the date of death from any cause or the last date the subject was known to be alive or 5 years whichever occurs first.
Outcome Time Frame:
The interval from date of randomization to the date of death from any cause or the last date the subject was known to be alive or 5 years whichever occurs first.
Safety Issue:
No
Principal Investigator
Eisai Medical Services
Investigator Role:
Study Director
Investigator Affiliation:
Eisai Global Clinical Development
Authority:
United States: Food and Drug Administration
Study ID:
DACO-016
NCT ID:
NCT00260832
Start Date:
November 2005
Completion Date:
December 2010
Related Keywords:
- Acute Myeloid Leukemia
- Acute Myeloid Leukemia
- Dacogen
- Decitabine
- Poor or intermediate-risk cytogenetics
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
Name | Location |
|---|---|
| Hinsdale, Illinois 60521 | |
| Bettendorf, Iowa 52722 | |
| Fountain Valley, California 92708 | |
| Miami, Florida 33176 | |
| Albany, New York 12208 | |
| Cleveland, Ohio 44195 | |
| Philadelphia, Pennsylvania 19104 | |
| Nashville, Tennessee 37203-1632 | |
| Austin, Texas 78705 | |
| Flint, Michigan 48532 | |
| Kansas City, Kansas 66160 | |
| Hackensack, New Jersey 07601 | |
| Metairie, Louisiana 70006 | |
| Boston, Massachusetts | |
| Charlotte, North Carolina | |
| Milwaukee, Wisconsin | |
| Indianapolis, Indiana | |
| Charleston, South Carolina | |
| Sioux Falls, South Dakota |
