Phase 2
Completed N=10
Azacytidine With Valproic Acid Versus Ara-C in Acute Myeloid Leukemia (AML)/ Myelodysplastic Syndrome (MDS) Patients
Source: ClinicalTrials.gov NCT00382590 ↗Enrolled (actual)
10
Serious AEs
100.0%
Results posted
Apr 2011
Primary outcomePrimary: Number of Participants With Response — 0; 0; 4; 5 Participants
Summary
Primary Objective:
1. To evaluate whether 5 azacytidine (5-aza)/valproic acid (VPA) or low dose ara-C produces longer event free survival time in patients age > or = 60 years with untreated Acute Myeloid Leukemia (AML) or high risk Myelodysplastic Syndrome (MDS) who are typically ineligible for, or not placed on, studies of new agents.
Secondary Objective:
1. To evaluate whether pre-treatment methylation/acetylation status in AML/MDS blasts predicts response to either therapy or whether the ability of the 5 azacytidine + valproic acid combination to induce demethylation or acetylation parallels response.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Response |
0; 0; 4; 5; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must have untreated AML, or untreated MDS with > 10% blasts in marrow or blood.
- They must be at least age 60.
- They must either have a serum creatinine > 1.9 mg/ml, a serum bilirubin > 1.9 mg/ml, or a Zubrod performance status of 3 or 4.
- Alternatively, they must not be candidates for protocols of higher priority.
- They must provide written consent.
Exclusion Criteria
- Must not have the cytogenetic abnormalities inv (16), t (16;16) t (8;21), or t (15;17). The relatively good prognoses of patients with these findings do not warrant use of 5 azacytidine, + valproic acid or low-dose ara-C (LDAC).
Data sourced from ClinicalTrials.gov (NCT00382590). 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.