S1203 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)
This research is being done to compare the effects, good and/or bad of three drug combinations. The first combination is the standard treatment of Cytarbine (Ara-C) plus daunorubicin,called 7+3 treatment. The second combination is another standard treatment of idarubicin plus Cytarabine (Ara-C), called IA treatment. Both of these treatments have been approved for acute myeloid leukemia. The third combination will add the drug vorinostat to the standard IA therapy. We want to see if the study regimens will get rid of leukemia cells and keep them from coming back for subjects who may benefit from stem cell transplant. We also want to find stem cell transplant donors for subjects who might benefit from a transplant according to standard practice, beginning at the time subjects register for the study.
Generally healthy adults between the ages of 18 and 60 years who have recently been diagnosed with acute myelogenousleukemia (AML) may be eligible if they also meet the following additional requirements:* Have not received chemotherapy,* Have not taken valproic acid,* Normal heart tests,* Women are not pregnant or nursing, and* Able to take medication by mouth.
Standard induction therapy for patients with acute myeloid leukemia (AML) consists of the combination of cytarabine(AraC) plus an anthracycline, the so called 7+3 schema. A combination of daunorubicin at 90 mg/m2 for 3 days andcytarabine at either 100 or 200 mg/m2 for 7 days is generally considered to be ï¿½standard.The last decade has witnessed a remarkable increase in the understanding of the disease, but current therapies still needimprovement. A subgroup of the National Cancer Institute (NCI) LeukemiaSteering Committee (NCI AML Working Group Subgroup 3) was charged with developing a strategy for developing thenext intergroup clinical trials of upfront therapy for younger patients with AML. This study is one product of this groupï¿½swork.
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