UI Hospitals and Clinics

Clinical Trial Details

Short Title
A Randomized Phase III Study of Standard Cytarabine plus Daunorubicin (7+3) Therapy or Idarubicin with High Dose Cytarabine (IA) versus IA with Vorinostat (IA+V) in Younger Patients with Previously Untreated Acute Myeloid Leukemia (AML)
Official Title

A Randomized Phase III Study of Standard Cytarabine plus Daunorubicin (7+3) Therapy or Idarubicin with High Dose Cytarabine (IA) versus IA with Vorinostat (IA+V) in Younger Patients with Previously Untreated Acute Myeloid Leukemia (AML)

Description

Participants in this research study have untreated acute myeloid leukemia (AML) and will receive one of three drug combinations. The first combination is the standard treatment of daunorubicin plus AraC. This is called "7+3" treatment. The second combination is another standard treatment of idarubicin plus AraC. This is called "IA" treatment. Both of these treatments have been approved by the U.S. Food and Drug Administration (FDA) for the treatment of AML. The third combination will add the drug vorinostat to the standard IA therapy (idarubicin plus AraC). Vorinostat is approved by the FDA for other types of cancer, but has not been FDA approved for your AML, so it is considered investigational for this study. Investigators want to compare the effects of these three treatments. The purpose of this research study is to compare the effects, good and/or bad of three drug combinations.

Also this study will see if the study treatments will get rid of leukemia cells and keep them from coming back for individuals who may benefit from stem cell transplant. Another purpose of this study is to find stem cell transplant donors for individuals who might benefit from a stem cell transplant according to standard practice.

Approximately 20 people will take part in this study conducted by investigators at the University of Iowa. About 784 subjects will take part in this study nationwide.

Start Date
June 26, 2013
End Date
June 1, 2016
Gender Preference
None
Age Group
18 - 99 years
Principal Investigator
Thomas Carter, MD, PhD
Contact Info

Clarine Halvorsen, 319-356-3944

Department
Department or Field of Study
Keywords
acute myeloid leukemia (AML) ; cancer ; IRB#201305721 ; phase III ; phase three ; thomas ;

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