Sirolimus, Idarubicin, and Cytarabine in Treating Patients With Newly Diagnosed Acute Myeloid Leu… (NCT01822015) | Clinical Trial Compass
CompletedEarly Phase 1
Sirolimus, Idarubicin, and Cytarabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
United States55 participantsStarted 2013-03-15
Plain-language summary
This pilot clinical trial studies sirolimus, idarubicin, and cytarabine in treating patients with newly diagnosed acute myeloid leukemia. Sirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving sirolimus together with idarubicin and cytarabine may kill more cancer cells.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients must have histologic evidence of newly diagnosed acute myeloid leukemia (non-M3 AML) as documented by the presence of \>20% myeloid blasts in the bone marrow
✓. Subjects must be 18 years of age and \<= 60
✓. Subjects must have an ECOG performance status of 2 or less. (see attachment 1).
✓. Subjects must have a life expectancy of at least 4 weeks.
✓. Subjects must be able to consume oral medication.
✓. Required initial laboratory values: Creatinine 2.0mg/dL; total or direct bilirubin 1.5mg/dL; SGPT(ALT) 3xULN (if not due to the leukemia itself); negative pregnancy test for women with child-bearing potential.
✓. Patients must be able to sign consent and be willing and able to comply with scheduled visits, treatment plan and laboratory testing.
✓. Subjects must have a left ventricular ejection fraction (LVEF) of \>/= 45%.
Exclusion criteria
✕
What they're measuring
1
Change in measurement of mTOR activation paired with mTOR target inhibition
Timeframe: Baseline to day 4
Trial details
NCT IDNCT01822015
SponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
. Subjects with APL - FAB M3 (t(15;17)(q22;q21)\[PML-RAR\] are not eligible
✕. Subjects must not have received any chemotherapeutic agents for the AML (except Hydroxyurea). Intrathecal ARA-C and intrathecal methotrexate are permissible (as they are not systemic and only isolated to the central nervous system).
✕. Subjects must not be receiving growth factors, except for erythropoietin.
✕. Subjects with a "currently active" second malignancy, other than non-melanoma skin cancers are not eligible.
✕. Subjects with uncontrolled high blood pressure, unstable angina, symptomatic congestive heart failure, myocardial infarction within the past 6 months or serious uncontrolled cardiac arrhythmia are not eligible.
✕. Subjects taking the following are not eligible: