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Sponsor: Novartis Pharmaceuticals
Conditions: FLT3-mutated Acute Myeloid Leukemia
Interventions: Midostaurin, Fludarabine, Cytarabine, Daunorubicin or idarubicin, Mitoxantrone
Countries: Czechia, Germany, Italy, Japan, Jordan, Poland, Russia, Slovenia
This study will evaluate the safety, efficacy and pharmacokinetics of midostaurin in combination with standard chemotherapy in pediatrics patients with newly diagnosed FLT3-mutated Acute Myeloid Leukemia. The study has two parts: Part 1 to define the Recommended Phase 2 Dose, and Part 2 to evaluate safety and tolerability and efficacy of midostaurin. Both parts will consist of 2 induction blocks, 3 consolidation blocks, 12 cycles of post-consolidation consisting of continuous therapy with midostaurin, and a follow-up phase.
Sex: ALL
Age: 3 Months to 17 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * Documented Diagnosis of previously untreated de novo AML according to WHO 2016 criteria * Presence of a FLT3 mutation status as measured/confirmed by a designated lab with results available prior first dose of Midostaurin * Patients with Lansky or Karnofsky performance status equal or superior to 60 * Patient with the following laboratory value : AST and ALT ≤ 3times ULN * Serum Total bilirubin ≤ 1.5times ULN * Estimated creatinine clearance ≥30ml/min Exclusion Criteria: * Any concurrent malignancy, AML with Philadelphia Chromosome, AML-DS, JMML * Symptomatic leukemic CNS involvement * Isolated extramedullary leukemia, secondary AML and MDS * Acute Promyelocytic Leukemia with the PML RARA rearrangement * Patient who have received prior treatment with a FLT3 inhibitor. However, up to 1 week of FLT3 inhibitor (except midostaurin) exposure prior to study enrollment is permissible. Other protocol-defined inclusion/exclusion criteria may apply
- Prague, Czechia
- Berlin, Germany
- Essen, Germany
- Pavia, PV, Italy
- Roma, RM, Italy
- Torino, TO, Italy
- Naples, Italy
- Osaka, Japan
- Amman, Jordan
- Krakow, Poland
- Moscow, Russia
- Ljubljana, Slovenia
- Seoul, South Korea
- Seoul, South Korea
- Adana, Adana, Turkey (Türkiye)