Managed Access Programs for PKC412, Midostaurin

Study Overview
=================
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)

Official Title
-----------------
Managed Access Programs for PKC412, Midostaurin

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

Intervention / Treatment
-----------------
* Drug: midostaurin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: An independent request should be received from a licensed physician (in some instances from Health Authorities, Institutions or Governments). The patient has a serious or life-threatening disease or condition and no comparable or satisfactory alternative therapy is available for diagnosis, monitoring or treatment; patient is not medically eligible for available treatment alternatives or has exhausted all available treatment options. The patient is not eligible or able to enroll in a Novartis clinical trial or continue participation in a Novartis clinical trial. There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated. The patient must meet any other medical criteria established by the medical experts responsible for the product or by the Health Authority in a country (as applicable). Provision of the product will not interfere with the initiation, conduct or completion of a Novartis clinical trial or overall development program. Managed access provision is allowed per local laws/regulations.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: midostaurin|Patients receive midostaurin|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FLT3-mutated AML, AML, Aggressive systemic mastocytosis, Mast cell leukemia, Systemic mastocytosis with an associated hematologic neoplasm, MAP, Manage access program, PKC412, Midostaurin