Phase 2 N=10 Randomized Treatment

Azacytidine With Valproic Acid Versus Ara-C in Acute Myeloid Leukemia (AML)/ Myelodysplastic Syndrome (MDS) Patients

Acute Myelogenous Leukemia · Myelodysplastic Syndrome · Leukemia

Bottom Line

View on ClinicalTrials.gov: NCT00382590 ↗

Enrolled (actual)

Serious AEs

100.0%

Results posted

Apr 2011

Primary outcome: Primary: Number of Participants With Response — 0; 0; 4; 5 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: 5-Azacytidine (Drug); Ara-C (Drug); Valproic Acid (VPA) (Drug)
Age: Adult, Older Adult · 60+ yrs
Sex: All
Sponsor: M.D. Anderson Cancer Center
Primary completion: Feb 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Response	0; 0; 4; 5; 0; 0	—

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.

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).

View full record on ClinicalTrials.gov →

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.