Phase 3
N=485
Trial of Decitabine in Patients With Acute Myeloid Leukemia
Acute Myeloid Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00260832 ↗Enrolled (actual)
485
Serious AEs
74.1%
Results posted
Sep 2011
Primary outcome: Primary: Overall Survival in Patients 65 Years or Older Who Have Newly Diagnosed de Novo or Secondary AML. — 5.0; 7.7 months — p=0.1079
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Cytarabine or Supportive Care (Drug); Dacogen (decitabine) only (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Eisai Inc.
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival in Patients 65 Years or Older Who Have Newly Diagnosed de Novo or Secondary AML. |
5.0; 7.7 | 0.1079 |
| SECONDARY Percentage of Participants With Complete Remission (CR) Plus Complete Remission With Incomplete Platelet Recovery (CRp) |
7.8; 17.8 | 0.0011 sig |
Summary
The purpose of this study is to compare the results in older patients who have newly diagnosed or secondary acute myeloid leukemia (AML) and who are to either receive decitabine or patient's choice with the physician's advice of either cytarabine or supportive care medication.
Eligibility Criteria
Inclusion Criteria
- Must have diagnosed acute myeloid leukemia.
- Must have a life expectancy of at least 12 weeks.
- Must sign informed consent.
Exclusion Criteria
- Must not have acute promyelocytic leukemia (M3 classification)
- Must not have any other active systemic malignancies.
- Must not have inaspirable bone marrow.
- Must not have received previous chemotherapy (except hydroxyurea) for any myeloid disorder.
- Must not have chronic respiratory disease that requires continuous oxygen use.
- Must not have received any experimental drug within 4 weeks before randomization.
- Must not be a candidate for a bone marrow or stem cell transplant within 12 weeks after randomization.
- Must not have known HIV.
Data sourced from ClinicalTrials.gov (NCT00260832). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.