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

Completed · Phase 2

Conditions studied: Acute Myelogenous Leukemia, Myelodysplastic Syndrome, Leukemia

In brief

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.

Key facts

Study ID

NCT00382590

Run by

M.D. Anderson Cancer Center

People needed

11

Starts

2005-08-01

Expected to finish

2008-02-01

Last updated by the study team

2012-08-07

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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