At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II, Randomized Trial of Standard of Care, With or Without Midostaruin to Prevent Relapse Following Allogeneic Hematopoietic Stem Cell Transplantation in Patients With FLT3-ITD Mutated Acute Myeloid Leukemia
In Brief
A Phase 2 clinical trial evaluating Midostaurin and Standard of Care for Acute Myeloid Leukemia. Completed, enrolled 60 participants across 19 sites in 2 countries.
Detailed Summary
To determine if the addition of midostaurin (PKC412) to Standard of Care (SOC) therapy reduces relapse in FLT3-ITD mutated AML patients receiving an allogenetic hematopoietic stem cell transplant,
Study Details
Timeline
Interventions
Midostaurin was supplied in 25mg soft gelatin capsule taken orally twice a day for 28 days of each cycle. Patients will be treated for 12 cycles.
Standard of Care was not defined per protocol. The investigator prescribed based on the commonly used medications given in the post SCT setting.