CompletedPhase 2

Trial to Assess the Efficacy of Midostaurin (PKC412) in Patients With c-KIT or FLT3-ITD Mutated t(8;21) AML

Germany18 participantsStarted 2013-03-13

Plain-language summary

To assess the efficacy of tyrosine-kinase inhibitor midostaurin in c-KIT or FLT3-ITD mutated t(8;21) AML. To assess the efficacy of midostaurin depending on the type of c-KIT mutation

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. \>20% myeloid blasts in bone marrow and/or peripheral blood at initial diagnosis
✓. Plus cytogenetic diagnosis of aberration t(8;21)/AML1-ETO
✓. Plus mutation of c-KIT gene (mut-KIT17 or mut-KIT8) or FLT3-ITD mutation or both c-KIT and FLT3-ITD mutations

What they're measuring

Event-free Survival

Timeframe: 2-year Event-free Survival

Trial details

NCT IDNCT01830361

SponsorTechnische Universität Dresden

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-10-30

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