Managed Access Programs for PKC412, Midostaurin

Acute Myeloid Leukemia Clinical Trial

Official title:

Managed Access Programs for PKC412, Midostaurin

Clinical Trial Details — Status: Available

Administrative data

• NCT number: NCT05219266
• Other study ID #: CPKC412A2407I
• Status: Available

Study information

• Verified date: April 2024
• Source: Novartis
• Contact: MAP requests are initiated by a treating physician.https:// www.
• Phone: 1-888-669-6682
• Email: novartis.email[@]novartis.com
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Available
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Aggression
• Aggressive Systemic Mastocytosis
• Hematologic Neoplasms
• Leukemia
• Leukemia, Mast-Cell
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Mast Cell Leukemia
• Mastocytosis
• Systemic Mastocytosis With an Associated Hematologic Neoplasm

Intervention

Drug:
• midostaurin
Patients receive midostaurin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals