Azacytidine With Valproic Acid Versus Ara-C in Acute Myeloid Leukemia (AML)/ Myelodysplastic Syndrome (MDS) Patients
Acute Myelogenous Leukemia, Myelodysplastic Syndrome, Leukemia
About this trial
This is an interventional treatment trial for Acute Myelogenous Leukemia focused on measuring Acute Myelogenous Leukemia, AML, Myelodysplastic Syndrome, Leukemia, MDS, Azacytidine, 5-Azacytidine, 5-aza, Vidaza, 5-AZC, AZA-CR, Ladakamycin, Ara-C, Cytarabine, Cytosar, DepoCyt, Cytosine arabinosine hydrochloride, Valproic Acid, VPA, Depakene
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:
1) 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).
Sites / Locations
- UT MD Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
5-Aza + VPA
Ara-C
5-Azacytidine (5-Aza) 75 mg/m^2 subcutaneously daily + Valproic Acid (VPA) 50 mg/m^2 orally daily, each for 7 days
Low-Dose Ara-C 20 mg twice daily subcutaneously for 10 days.