Standard of Care +/- Midostaurin to Prevent Relapse Post Stem Cell Transplant in Patients With FLT3-ITD Mutated AML

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,

Timeline

Start

2014-02-06

Primary completion

2018-04-30

Completion

2018-04-30

Outcome

Missed primary endpoint

registry analysis (superiority test); Standard of Care With Midostaurin vs Standard of Care; p = 0.2655; Hazard Ratio (HR) 0.46 (95% CI 0.12 to 1.86); Log Rank NCT01883362 ↗

Publications

• Maziarz RT, Levis M, Patnaik MM, Scott BL, Mohan SR, Deol A, Rowley SD, Kim DDH, Hernandez D, Rajkhowa T, Haines K, Bonifacio G, Rine P, Purkayastha D, Fernandez HF. Midostaurin after allogeneic stem cell transplant in patients with FLT3-internal tandem duplication-positive acute myeloid leukemia. Bone Marrow Transplant. 2021 May;56(5):1180-1189. doi: 10.1038/s41409-020-01153-1. Epub 2020 Dec 7.

Drugs

Indications