Clinical trial NCT05219266: Managed Access Programs for PKC412, Midostaurin
Official title: Managed Access Programs for PKC412, Midostaurin
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
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
Keywords: FLT3-mutated AML
AML
Aggressive systemic mastocytosis
Mast cell leukemia
Systemic mastocytosis with an associated hematologic neoplasm
MAP
Manage access program
PKC412
Midostaurin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-02-02
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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 - 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)

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.

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