Managed Access Programs for ABL001, Asciminib

Sponsor: Novartis Pharmaceuticals

Expanded Access
Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04360005

Patient View

The Managed Access Programs for Asciminib provide access to patients with serious or life-threatening conditions lacking alternative therapies. Eligibility requires a physician's request, patient ineligibility for clinical trials, and a favorable risk-benefit assessment. Asciminib is administered under these programs, adhering to local regulations and ensuring no interference with ongoing Novartis trials.

Patient Parameters

Program Overview

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

Eligibility 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

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