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Managed Access Program (MAP)* to Provide Access to Asciminibfor Patients With CML in Chronic Phase

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. Identifier: NCT04360005
Expanded Access Status : Available
First Posted : April 24, 2020
Last Update Posted : April 24, 2020
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date April 21, 2020
First Posted Date April 24, 2020
Last Update Posted Date April 24, 2020
Descriptive Information
Brief Title Managed Access Program (MAP)* to Provide Access to Asciminibfor Patients With CML in Chronic Phase
Brief Summary This program provides access to asciminib for patients with CML in chronic phase, with or without documented T315I mutation, without comparable or satisfactory alternative therapy to treat the disease
Detailed Description Not Provided
Study Type Expanded Access
Intervention Drug: Asciminib
Asciminib 20 or 40 mg strength tablets will be administered orally twice-daily, without food
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Expanded Access Status Available
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals
Listed Location Countries Not Provided
Removed Location Countries  
Administrative Information
NCT Number NCT04360005
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor Novartis Pharmaceuticals
Collaborators Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date April 2020