drugset / Trial / NCT01130662

Combination of Decitabine and Midostaurin in Patients Older Than 60 With Newly Diagnosed or Relapsed Refractory Acute Myeloid Leukemia

NCT01130662

Phase 1 Completed 16 enrolled University of Kansas Novartis · collab
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the tolerated dose of the combination of decitabine and midostaurin as induction (first cycle of chemotherapy) and consolidation (additional chemotherapy once a patient goes into remission) in people greater than 60 years with newly diagnosed AML or adult patients with relapsed/refractory disease.

Timeline

Start
2010-03
Primary completion
2011-10
Completion
2011-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Decitabine Small molecule 20 mg/m2 Intravenous
Subject Midostaurin Small molecule 25 mg Oral
Subject Midostaurin Small molecule 50 mg Oral