Finding studies
Finding studies
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Lead
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
PRIMARY OBJECTIVES: 1\) To determine whether there is an association between baseline mammalian target of rapamycin (mTOR) activation paired with mTOR target inhibition post-treatment in leukemic blasts and clinical response in patients with newly diagnosed acute myeloid leukemia (AML) treated with sirolimus idarubicin/cytarabine. SECONDARY OBJECTIVES: 1. To estimate the response rate of sirolimus idarubicin/cytarabine in patients with newly diagnosed AML compared to historical data using idarubicin/cytarabine alone. 2. To determine the ability of oral sirolimus to inhibit mTOR in leukemic blasts. 3. To assess if mTOR pathway inhibition correlates with clinical response. 4. To collect further information on the safety, tolerability, and efficacy of sirolimus in combination with idarubicin/cytarabine in patients with newly diagnosed AML. 5. To describe the progression-free survival and overall survival (1 year, 2 year and 5 year) of patients treated with sirolimus idarubicin/cytarabine. OUTLINE: Patients receive sirolimus orally (PO) once daily (QD) on days 1-10, idarubicin intravenously (IV) over 3-5 minutes on days 4-6, and cytarabine IV continuously over 24 hours on days 4-10. After completion of study treatment, patients are followed up every 3 months for 5 years.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
