Acute Myeloid Leukemia Clinical Trial
— MIDOKITOfficial title:
A Single-arm Phase II Trial to Assess the Efficacy of Midostaurin (PKC412) Added to Standard Primary Therapy in Patients With Newly Diagnosed c-KIT or FLT3-ITD Mutated t(8;21) AML
Verified date | August 2020 |
Source | Technische Universität Dresden |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 18 |
Est. completion date | October 30, 2019 |
Est. primary completion date | October 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Diagnosis of c-KIT mutated t(8;21) AML i.e. 1. >20% myeloid blasts in bone marrow and/or peripheral blood at initial diagnosis 2. Plus cytogenetic diagnosis of aberration t(8;21)/AML1-ETO 3. 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Klinikum Chemnitz gGmbH, Klinik für Innere Medizin III | Chemnitz | |
Germany | Universitätsklinikum Dresden Medizinische Klinik und Poliklinik I | Dresden | |
Germany | Universitätsklinikum Erlangen, Medizinische Klinik 5 | Erlangen | |
Germany | Klinikum der Johann-Wolfgang-Goethe Universität | Frankfurt Main | |
Germany | Universitätsklinikum Heidelberg | Heidelberg | |
Germany | Universitätsklinikum Jena, Klinik für Innere Medizin II | Jena | |
Germany | Universitätsklinikum Gießen und Marburg GmbH | Marburg | |
Germany | Universitätsklinikum Münster | Münster | |
Germany | Städtisches Klinikum Nord | Nürnberg | |
Germany | Klinikum der Universität Regensburg | Regensburg |
Lead Sponsor | Collaborator |
---|---|
Technische Universität Dresden | Novartis Pharmaceuticals |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Event-free Survival | 2-year Event-free Survival | ||
Secondary | Time to relapse | 2-years | ||
Secondary | Overall survival | 2-years | ||
Secondary | Relapse-free survival | 2-years | ||
Secondary | morphologic and molecular CR rate | 2-years | ||
Secondary | incidence of AEs/SAEs | until 30 days after end of treatment | ||
Secondary | MRD kinetics (molecular residual disease) | molecular diagnostics of markers in peripheral blood / bone marrow | 2-years | |
Secondary | Cumulative incidence of relapse | 2-year |
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