drugset / Trial / NCT01154439

Everolimus MICE-regimen in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia

NCT01154439

Phase 1 Completed 11 enrolled GIMEMA Foundation
NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy, such as mitoxantrone hydrochloride, cytarabine, etoposide, and idarubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Giving everolimus together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when given together with mitoxantrone hydrochloride, cytarabine, etoposide, and idarubicin in treating older patients with newly diagnosed acute myeloid leukemia.

Timeline

Start
2010-10
Primary completion
2013-05
Completion
2015-09-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Everolimus Small molecule Oral
Background Cytarabine Small molecule Intravenous
Background Etoposide Small molecule Intravenous
Background Idarubicin Small molecule Other
Background Mitoxantrone Small molecule Intravenous

Indications