NCT01188889

RAD001 in Patients With Chronic Phase Chronic Myeloid Leukemia w/ Molecular Disease.

An Open Label, Time-To-Event Continuous Reassessment Method, Phase I/II Study of the Mammalian Target of Rapamycin (mTOR) Inhibitor RAD001 in Combination With Imatinib (Gleevec) in Patients With Chronic Phase Chronic Myeloid Leukemia (CML) With Persistent Molecular Disease.

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients participating in this study will have a diagnosis of Chronic Myeloid Leukemia. This study will evaluate whether the addition of an investigational drug called RAD001 given together with Imatinib will better target leukemia stem cells, causing them to die. Stem cells are a small population of cells, existing primarily within the bone marrow, and are believed to be responsible for the ongoing risk of disease relapse.

Conditions

• Chronic Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	RAD001	Dosing schedule of RAD001 for the Phase I portion: Regimen 1. 5.0 mg q72 hours (400 mg QD); Regimen 2. 5 mg q48 hours (400 mg QD); Regimen 3. 5.0 mg q day (400 mg QD); Regimen 4. 7.5 mg PO q day (400 mg QD.
DRUG	Imatinib	Imatinib will be given continuously at a fixed daily dose of 400 mg once daily.

Timeline

• Start date: 2013-09-01
• Primary completion: 2016-12-01
• Completion: 2017-12-01
• First posted: 2010-08-26
• Last updated: 2015-05-15

Locations

1 site across 1 country: United States