Managed Access Programs for ABL001, Asciminib
- Conditions
- Chronic Myeloid Leukemia in Chronic Phase
- Registration Number
- NCT04360005
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
The purpose of this registration form is to list all Managed Access Programs (MAPs) related to ABL001, asciminib
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- 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
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method