Spots Global Cancer Trial Database for Managed Access Programs for PKC412, Midostaurin

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Trial Identification

Brief Title: Managed Access Programs for PKC412, Midostaurin

Official Title: Managed Access Programs for PKC412, Midostaurin

Study ID: NCT05219266

Conditions

FMS-Like Tyrosine Kinase 3 (FLT3)-Mutated Acute Myeloid Leukemia

Acute Myeloid Leukemia

Aggressive Systemic Mastocytosis

Mast Cell Leukemia

Systemic Mastocytosis With an Associated Hematologic Neoplasm

Interventions

midostaurin

Study Description

Brief Summary: The purpose of this registration is to list Managed Access Programs (MAPs) related to PKC4, Midostaurin.

Detailed Description: * CPKC412A2001X - No longer available- An open-labeled, multi-center, Expanded Treatment Protocol (ETP) of midostaurin (PKC412) in patients 18 years of age or older with newly-diagnosed FLT3-mutated acute myeloid leukemia (AML) who are eligible for standard induction and consolidation chemotherapy * CPKC412AUS56X - No longer available - An open-label, multi-center, Expanded Treatment Protocol of Midostaurin (PKC412) in adult patients with newly diagnosed Fms-like tyrosine kinase receptor (FLT3) mutated Acute Myeloid Leukemia (AML) who are eligible for standard induction and consolidation chemotherapy. * CPKC412A2407I - Available - Managed Access Program (MAP) Cohort Treatment Plan CPKC412A2407I to provide access to midostaurin (PKC412) for patients 18 years of age and older with newly-diagnosed FLT3-mutated AML and eligible for induction and consolidation chemotherapy * CPKC412D2001M - Available - Managed Access Program (MAP) to provide access to Midostaurin (PKC412), for an individual patient with aggressive systemic mastocytosis (ASM), mast cell leukemia (MCL) or mast cell sarcoma (MCS)