Status:
COMPLETED
Azacytidine With Valproic Acid Versus Ara-C in Acute Myeloid Leukemia (AML)/ Myelodysplastic Syndrome (MDS) Patients
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Acute Myelogenous Leukemia
Myelodysplastic Syndrome
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief 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 M...
Detailed Description
5-aza is a chemotherapy drug with activity in leukemia and MDS. Researchers hope that VPA will increase the effects of 5-aza. Low-dose Cytarabine (ara-C) is considered the standard of care for the tre...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00382590
Start Date
August 1 2005
End Date
February 1 2008
Last Update
August 7 2012
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030