NCT01826214

Study of Efficacy and Safety of LDE225 in Adult Patients With Relapsed/Refractory Acute Leukemia

A Phase II Multi-center, Open Label, Randomized Study to Assess Safety and Efficacy of Two Different Schedules of Oral LDE225 in Adult Patients With Relapsed/Refractory or Untreated Elderly Patients With Acute Leukemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will evaluate the efficacy, safety and tolerability of two dosing schedules of LDE225 in patients with relapsed/refractory acute leukemia or elderly patients with untreated acute leukemia.

Conditions

• Acute Leukemias

Interventions

Type	Name	Description
DRUG	LDE225	LDE225 will be supplied as 200 mg capsules by Novartis. Patients will receive study treatment on an outpatient basis. LDE225 will be dispensed every two weeks for the first four weeks and at the start of every four weeks thereafter, as needed.

Timeline

• Start date: 2013-05-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2013-04-08
• Last updated: 2016-08-30
• Results posted: 2016-05-20

Locations

23 sites across 11 countries: United States, Australia, Austria, Belgium, Canada, Germany, Hungary, Netherlands, Norway, Spain, United Kingdom