Managed Access Programs for ABL001, Asciminib

Chronic Myeloid Leukemia in Chronic Phase Clinical Trial

Official title:

Managed Access Programs for ABL001, Asciminib

Clinical Trial Details — Status: Available

Administrative data

• NCT number: NCT04360005
• Other study ID #: CABL001A02401M
• Status: Available

Study information

• Verified date: May 2024
• Source: Novartis
• Contact: MAP requests are initiated by a licensed 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 form is to list all Managed Access Programs (MAPs) related to ABL001, asciminib

Recruitment information / eligibility

• Status: Available
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

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 enrol 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

• Chronic Myeloid Leukemia in Chronic Phase
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

Drug:
• Asciminib
Patients receive Asciminib

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals