Managed Access Programs for ABL001, Asciminib

Last updated: December 1, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Planned

Phase

N/A

Condition

Chronic Myeloid Leukemia

Leukemia

Platelet Disorders

Treatment

Asciminib

Clinical Study ID

NCT04360005
CABL001A02401M
  • Ages 18-99
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

Study Design

Treatment Group(s): 1
Primary Treatment: Asciminib
Phase:
Study Start date:
Estimated Completion Date: