drugset / Trial / NCT01184898

Pilot Trial of Sirolimus/MEC in High Risk Acute Myelogenous Leukemia (AML)

NCT01184898

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the addition of Sirolimus (rapamycin) to standard chemotherapy for the treatment of patients with high risk acute myelogenous leukemia (AML). Cancer cells taken from the patients will be studied in the laboratory to see if rapamycin is affecting the mTOR pathway in the cells and if this effect is correlated with how well patients respond to the therapy.

Timeline

Start
2010-07
Primary completion
2012-01
Completion
2016-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Sirolimus Small molecule 4 mg Oral
Background Cytarabine Small molecule 1000 mg/m2 Intravenous
Background Etoposide Small molecule 100 mg/m2 Intravenous
Background Mitoxantrone Small molecule 8 mg/m2 Intravenous