Status:
COMPLETED
Trial to Assess the Efficacy of Midostaurin (PKC412) in Patients With c-KIT or FLT3-ITD Mutated t(8;21) AML
Lead Sponsor:
Technische Universität Dresden
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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
Detailed Description
AML patients displaying t(8;21) have a relatively favourable outcome. Nevertheless, only approximately 50% of patients carrying this cytogenetic aberration are alive at 5 years. This suggests that som...
Eligibility Criteria
Inclusion
- Diagnosis of c-KIT mutated t(8;21) AML i.e.
- \>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
- Chemoresponsive disease as determined by early bone marrow assessment on day 14-16 after first cycle of induction therapy with cytarabine in combination with daunorubicine or idarubicine, or mitoxantrone- Fit for further intensive chemotherapy
- Age 18-65 years
- ECOG performance status of 0-2
- Life expectancy of at least 12 weeks
Exclusion
- Primary refractory or previously relapsed AML
- Non-eligibility for high-dose cytarabine based consolidation, e.g. intolerance to cytarabine
- Inability to swallow oral medications
- Symptomatic congestive heart failure
- Bilirubin \>2.5 x upper limit of normal
Key Trial Info
Start Date :
March 13 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2019
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01830361
Start Date
March 13 2013
End Date
October 30 2019
Last Update
August 6 2020
Active Locations (10)
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1
Klinikum Chemnitz gGmbH, Klinik für Innere Medizin III
Chemnitz, Germany
2
Universitätsklinikum Dresden Medizinische Klinik und Poliklinik I
Dresden, Germany
3
Universitätsklinikum Erlangen, Medizinische Klinik 5
Erlangen, Germany
4
Klinikum der Johann-Wolfgang-Goethe Universität
Frankfurt am Main, Germany