NCT05219266

Managed Access Programs for PKC412, Midostaurin

• Status: No Longer Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 - No longer 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 - No longer 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)

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

Type	Name	Description
DRUG	midostaurin	Patients receive midostaurin

Timeline

• First posted: 2022-02-02
• Last updated: 2024-06-28