Phase II Study of Idarubicin, Cytarabine, and Vorinostat With High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)
|ClinicalTrials.gov Identifier: NCT00656617|
Recruitment Status : Completed
First Posted : April 11, 2008
Results First Posted : March 9, 2015
Last Update Posted : March 9, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia (AML) Myelodysplastic Syndrome (MDS)||Drug: Idarubicin Drug: Cytarabine Drug: Vorinostat||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||106 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Idarubicin, Cytarabine, and Vorinostat in Patients With High-Risk MDS and AML|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
Experimental: Idarubicin + Ara-C + Vorinostat
Idarubicin 12 mg/m^2 by vein (IV) over 1 hour daily for 3 days (days 4 to 6). Ara-C (Cytarabine) 1.5 g/m^2 IV 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 for 3 days (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).
- Progression Free Survival (PFS) at 7 Months [ Time Frame: PFS Evaluation at 7 months ]Progression-free survival defined as time from date of randomization to first occurrence of having documented disease progression or death due to any cause, whichever comes first. Progression based on tumor assessments according to Response Evaluation Criteria in Solid Tumors (RECIST). Participants were followed from baseline to disease progression with PFS evaluation at 7 months.
- Participant Response [ Time Frame: Monitoring with each 4 week cycle, up to 18 cycles of treatment ]Number of participants with response assessed according RECIST: 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%. Complete Response without platelet recovery (CRp) = CR, but platelets <100 x 109/L. Progressive disease (PD) defined as increase of blasts to > 10% after an initial response.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00656617
|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|