Managed Access Programs for ABL001, Asciminib

NCT04360005 | Unknown

• 1 other identifier: CABL001A02401M
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Chronic Myeloid Leukemia in Chronic Phase

Keywords

Chronic myeloid leukemia; CML; CML-CP; Asciminib; ABL001

Interventions

Asciminib DRUG

Patients receive Asciminib

Also known as: ABL001

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• An independent request was received from a licensed physician.
• 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.
• The patient is not eligible or able to enrol in a clinical trial or continue participation in such trial.
• 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.
• 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).
• Provision of the product will not interfere with the initiation, conduct, or completion of a Novartis clinical trial or overall development program.
• Managed Access provision is allowed per local laws/regulations

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

asciminib

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

1-888-669-6682; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: April 24, 2020
• Last Updated: December 5, 2025

Record last verified: 2025-12