Managed Access Programs for INC424, Ruxolitinib

Primary Myelofibrosis (PMF) Clinical Trial

Official title:

Managed Access Programs for INC424, Ruxolitinib

Clinical Trial Details — Status: Available

Administrative data

• NCT number: NCT04745637
• Other study ID #: CINC424A2405
• Status: Available

Study information

• Verified date: February 2024
• Source: Novartis
• Contact: MAP requests are initiated by a licensed physician.https:// www.
• Phone: 1-88-669-6682
• 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 INC424, Ruxolitinib

Description:

CINC424A2405 - Available - Managed Access Program (MAP) Cohort Treatment Plan CINC424A2405 to provide access to Ruxolitinib for patients with Primary Myelofibrosis (PMF) or Post Polycythemia Myelofibrosis (PPV MF) or Post-Essential Thrombocythemia Myelofibrosis (PET-MF)

CINC424A2001M - No longer available - Ruxolitinib Managed Access Program (MAP) for patients diagnosed with severe/very severe COVID-19 illness

CINC424B2002I - Available - Managed Access Program (MAP) Cohort Treatment Plan CINC424B2002I to provide access to Ruxolitinib for patients with Polycythemia Vera (PV)

CINC424C2001M - Available - Managed Access Program (MAP) Cohort Treatment Plan CINC424C2001M to provide access to ruxolitinib for steroid refractory acute and chronic Graft versus Host Disease (SR aGVHD and SR cGHVD).

Recruitment information / eligibility

• Status: Available
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

Inclusion criteria

1. An independent request was received from a licensed physician.

2. The patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment.

3. The patient is not eligible or able to enroll in a clinical trial or continue participation in such trial.

4. 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.

5. The patient must meet any other medical criteria established by the medical experts responsible for the product or by the health authority in the country of request (as applicable).

6. Provision of the product will not interfere with the initiation, conduct, or completion of a Novartis clinical trial or overall development program.

7. Managed Access provision is allowed per local laws/regulations.

Related Conditions & MeSH terms

• Bronchiolitis Obliterans Syndrome
• Graft vs Host Disease
• Polycythemia
• Polycythemia Vera
• Polycythemia Vera (PV)
• Post Polycythemia Myelofibrosis (PPV MF)
• Primary Myelofibrosis
• Primary Myelofibrosis (PMF)
• Severe/Very Severe COVID-19 Illness
• Thrombocythemia Myelofibrosis (PET-MF)
• Thrombocytosis

Intervention

Drug:
• Ruxolitinib
Patients receive Ruxolitinib

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals