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A multi-center, open-label study to determine the dose and safety of oral asciminib inpediatric patients with Philadelphia chromosome positive chronic myeloid leukemia inchronic phase (Ph+ CML-CP), previously treated with one or more tyrosine kinaseinhibitors
Study to Determine the Dose and Safety of Asciminib in Pediatric Patients With Chronic Myeloid Leukemia
| Sponsor: | Novartis |
| Enrolling: | Male and Female Patients |
| Study Length: | 5 Years |
| IRB Number: | AAAT8666 |
| U.S. Govt. ID: | NCT04925479 |
| Contact: | Nobuko Hijiya, MD: 2123059770 / nh2636@cumc.columbia.edu |
Additional Study Information:
The purpose of this study is to find the best dose of Asciminib that can be given safely in children with Philadelphia chromosome positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) having previously been treated with one or more tyrosine kinase inhibitors (TKIs). Tyrosine kinase inhibitors are a group of medications that block chemical messengers (enzymes) called tyrosine kinases. Tyrosine kinases help to send growth signals in cells, so blocking them stops the cell growing and dividing. In this study, Asciminib will be given by mouth twice a day.
This study is closed
Do You Qualify?
| Are you between 1 year and under 18 years of age for the pediatric formulation group? | Yes | No |
| Are you between 14 and under 18 years of age and do you weigh at least 40 kg for the adult formulation group? | Yes | No |
| Do you have Philadelphia chromosomepositive chronic myeloid leukemia in chronic phase (Ph+ CML-CP)? | Yes | No |
| Have you received prior treatment with at least one tyrosine kinase inhibitor (TKI)? | Yes | No |
| Have you experienced failure or intolerance to your most recent tyrosine kinase inhibitor (TKI) therapy? | Yes | No |