Managed Access Programs for ABL001, Asciminib

Novartis

Status

Conditions: Chronic Myeloid Leukemia in Chronic Phase

Treatments: Drug: Asciminib

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT04360005

CABL001A02401M

Details and patient eligibility

About

The purpose of this registration form is to list all Managed Access Programs (MAPs) related to ABL001, asciminib

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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