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Managed Access Programs for ABL001, Asciminib

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04360005
Expanded Access Status : Available
First Posted : April 24, 2020
Last Update Posted : May 14, 2024
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

Condition or disease Intervention/treatment
Chronic Myeloid Leukemia in Chronic Phase Drug: Asciminib

Study Design
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Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Managed Access Programs for ABL001, Asciminib

Resource links provided by the National Library of Medicine


Interventions
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Intervention Details:
  • Drug: Asciminib
    Patients receive Asciminib
    Other Name: ABL001
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04360005


Contacts
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Contact: MAP requests are initiated by a licensed physician.https:// www.novart is.com/healthcare-professionals/managed-access-programs 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04360005    
Other Study ID Numbers: CABL001A02401M
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: May 14, 2024
Last Verified: May 2024
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Chronic myeloid leukemia
CML
CML-CP
Asciminib
ABL001
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia
Neoplasms by Histologic Type
Neoplasms
Hematologic Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
 Chronic Disease
Disease Attributes
Pathologic Processes
Asciminib
Tyrosine Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action