Clinical trial · Interventional
Trial of Decitabine in Patients With Acute Myeloid Leukemia
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
NCT00260832CI-TRIAL-00040526completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytarabine or Supportive Care | Drug | — | UNRESOLVED |
| Dacogen (decitabine) only | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- Subject's choice of treatment with physician's advice. Subjects preselected their preference of supportive care (including IV fluids, nutrition, and antibiotics) or cytarabine. (These represent one intervention.)
- interventionNames
- Drug: Cytarabine or Supportive Care
- type
- ACTIVE_COMPARATOR
- label
- B
- interventionNames
- Drug: Dacogen (decitabine) only
Primary outcomes (1)
- measure
- Overall Survival in Patients 65 Years or Older Who Have Newly Diagnosed de Novo or Secondary AML.
- timeFrame
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDMayer J, Arthur C, Delaunay J, Mazur G, Thomas XG, Wierzbowska A, Ravandi F, Berrak E, Jones M, Li Y, Kantarjian HM. Multivariate and subgroup analyses of a randomized, multinational, phase 3 trial of decitabine vs treatment choice of supportive care or cytarabine in older patients with newly diagnosed acute myeloid leukemia and poor- or intermediate-risk cytogenetics. BMC Cancer. 2014 Feb 6;14:69. doi: 10.1186/1471-2407-14-69. PMID 24498872