Phase 2
Completed N=55
Study of Decitabine for Treatment of Older Patients With Acute Myeloid Leukemia (AML)
Source: ClinicalTrials.gov NCT00358644 ↗Enrolled (actual)
55
Serious AEs
72.7%
Results posted
Sep 2009
Primary outcomePrimary: Complete Response = Morphologic Complete Remission (mCR) — 13 Participants
Summary
The purpose of this study is to estimate the rate of complete remission, as well as overall survival, in older patients with Acute Myeloid Leukemia (AML).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Response = Morphologic Complete Remission (mCR) |
13 | — |
Eligibility Criteria
Inclusion Criteria
- A diagnosis of AML or transformed from myelodysplastic syndrome (MDS) within 2 weeks of study enrollment.
- Ineligible to receive intensive chemotherapy for their disease.
- Have not received any chemotherapy within 4 weeks of study enrollment and must have recovered from any treatment-related toxicities.
Exclusion Criteria
- Received previous treatment for AML.
- Previously received Vidaza.
- Received any other investigational agents within 30 days of first dose of study drug.
- Uncontrolled intercurrent illness.
- Had radiotherapy within 14 days prior to study enrollment.
Data sourced from ClinicalTrials.gov (NCT00358644). 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. Informational only — not medical advice.