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Decitabine With or Without Valproic Acid in MDS and AML
NCT00414310Phase 2
Key facts
- Status
- Completed
- Start
- Dec 2006
- Primary completion
- May 2015
- Countries
- 1
- Sponsor
- University of Texas MD Anderson Cancer Center
- Modality
- Small Molecules
- Drugs
- valproic acid
- Conditions
- myelodysplastic syndrome (MDS)acute myeloid leukemia (AML)chronic myelomonocytic leukemia (CMML)
01
Overview
Phase 2, randomised, open-label trial of valproic acid in myelodysplastic syndrome (MDS), acute myeloid leukemia (AML) and chronic myelomonocytic leukemia (CMML) (2 arms), sponsored by University of Texas MD Anderson Cancer Center. Primary endpoint: Participant Response Rates at 1 year. Started Dec 2006; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Decitabine
Decitabine 20 mg/m^2 IV over 1 hour daily for 5 days.
Decitabine + Valproic Acid
Decitabine 20 mg/m^2 IV over 1 hour daily for 5 days. Valproic Acid 50 mg/kg orally daily for 7 days.
03
Who it enrols
Patients with MDS (> 5% blasts or IPSS intermediate/high), CMML, or AML (age >= 60) without prior intensive chemotherapy or extensive prior hypomethylating agents, with adequate organ function.
04
Endpoints
Primary
Participant Response Rates
Secondary
Response Duration
Overall Survival Rate
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