Phase II Study of Idarubicin, Cytarabine, and Vorinostat With High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)
The goal of this clinical research study is to find the highest safe dose of vorinostat that can be given in combination with idarubicin and ara-C for the treatment of AML and high-risk MDS.
Once the highest safe dose is found, researchers will then try to learn if this combination treatment can help to control AML and high-risk MDS in newly diagnosed patients. The safety of this treatment combination will also be studied.
Acute Myeloid Leukemia (AML)
Myelodysplastic Syndrome (MDS)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Idarubicin, Cytarabine, and Vorinostat in Patients With High-Risk MDS and AML|
- Progression free survival [ Time Frame: 7 Months ] [ Designated as safety issue: No ]The primary outcome for this trial is progression-free survival. Complete Response (CR) defined as normalization of marrow (< 5% blasts) and of peripheral blood counts (neutrophil count > 1.109/L, platelet count > 100 x 109/L). Partial response (PR) defined as for CR in terms of peripheral counts but with reduction of marrow blasts by >50% compared to pretreatment values but above <5%. CRp = CR, but platelets <100 x 109/L. Progressive disease defined as increase of blasts to > 10% after an initial response.
|Study Start Date:||April 2008|
|Study Completion Date:||February 2014|
|Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Experimental: Idarubicin + Ara-C + Vorinostat
Idarubicin 12 mg/m^2 by vein over 1 hour daily x 3 (days 4 to 6). Ara-C ( Cytarabine)1.5 g/m^2 by vein as a continuous infusion over 24 hours daily (days 4 to 7). Vorinostat initial dose level 500 mg orally three times a day for 3 days (days 1 to 3).
12 mg/m^2 IV over 1 hour daily x 3 (days 4 to 6)
Other Name: Idamycin PFS®Drug: Cytarabine
1.5 g/m^2 IV as a continuous infusion over 24 hours daily (days 4 to 7)
Other Names:Drug: Vorinostat
Initial dose level 500 mg orally three times a day for 3 days (days 1 to 3).
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|United States, Texas|
|The University of Texas M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Guillermo Garcia-Manero, M.D.||M.D. Anderson Cancer Center|