Neoplasms

Blood and Lymph Conditions

All Conditions

Rare Diseases

Polycythemia Vera

Polycythemia

Hematologic Diseases

Bone Marrow Neoplasms

Hematologic Neoplasms

Bone Marrow Diseases

Myeloproliferative Disorders

Chronic Myeloproliferative Disorders

Patients may self-administer daily ruxolitinib tablets qd or bid orally, without regard to food, in accordance with specified dosing schedule provided by the investigator.

Ruxolitinib

Novartis Pharmaceuticals

The purpose of this Cohort Treatment Plan is to allow access to ruxolitinib for eligible patients diagnosed with Polycythemia Vera. The patient's Treating Physician should follow the suggested treatment guidelines and comply with all local health authority regulations.

The requesting Treating Physician must submit a request for access to drug (often referred to as Compassionate Use) to Novartis which will review and approve by the medical team experienced with the drug and indication.

MAP to Provide Access to Ruxolitinib, for Patients With Polycythemia Vera

Treatment Plan for Managed Access Program (MAP) to Provide Access to Ruxolitinib, for Patients With Polycythemia Vera (PV)

Immune System Diseases

Behaviors and Mental Disorders

Nervous System Diseases

Skin and Connective Tissue Diseases

Leukemia

Mastocytosis

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Aggression

Mastocytosis, Systemic

Leukemia, Mast-Cell

Neoplasms by Histologic Type

Dementia

Aberrant Motor Behavior in Dementia

Behavioral Symptoms

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Mast Cell Activation Disorders

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Systemic Mastocytosis

Antineoplastic Agents

All Drugs and Chemicals

Midostaurin

Protein Kinase Inhibitors

Enzyme Inhibitors

midostaurin

MAP requests are initiated by a treating physician.https:// www.novart is.com/healthcare-professionals/managed-access-programs.

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

* 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)

Managed Access Programs for PKC412, Midostaurin

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Lymphoma

Lymphoma, Large-Cell, Anaplastic

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Lymphosarcoma

Anaplastic Large Cell Lymphoma

Inflammatory Myofibroblastic Tumor

Amino Acids

Ceritinib

Tyrosine Kinase Inhibitors

Tyrosine

ceritinib

MAP requests are initiated by a licensed physician.https:// www.novart is.com/healthcare-professionals/managed-access-programs

The purpose of this registration is to list Managed Access Programs (MAPs) related to LDK378, Ceritinib.

CLDK378A2401 - No longer available - Managed Access Program (MAP) to provide access to Ceritinib, for ALK Positive Tumors.

CLDK378A2402 - No longer available - An open-label, multi-center, Expanded Treatment Protocol (ETP) of oral LDK378 in adult patients with non-small cell lung cancer (NSCLC) characterized by ALK positivity.

CLDK378A2003M - Available - Managed Access Program (MAP) Cohort Treatment Plan CLDK378A2003M to provide access to LDK378 (ceritinib), for ALK-Positive Tumor Pediatric Patients.

Managed Access Programs for LDK378, Ceritinib

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
MAP to Provide Access to Ruxolitinib, for Patients With Polycythemia Vera	NCT05269771	Polycythemia Ve...	Ruxolitinib	12 Years - 99 Years	Novartis
Managed Access Programs for PKC412, Midostaurin	NCT05219266	FMS-Like Tyrosi... Acute Myeloid L... Aggressive Syst... Mast Cell Leuke... Systemic Mastoc...	midostaurin	18 Years -	Novartis
Managed Access Programs for LDK378, Ceritinib	NCT05100134	Anaplastic Lymp... Non-small Cell ...	ceritinib	12 Years -	Novartis

Spots Global Cancer Trial Database for manage access program