This is a long term safety study for patients who have completed a Novartis sponsored asciminib study and are judged by the investigator to benefit from continued treatment
This is an open-label, multi-center, global roll-over study designed to assess long term safety and provide continued treatment to participants who have previously participated in an asciminib Novartis sponsored study and who, in the opinion of the investigator, would benefit from continued treatment as in their parent study but are unable to access this treatment outside of the clinical study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
347
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
All AEs and SAEs will be tabulated and listed for participants in the Safety Set by treatment group. From day of first administration of study treatment to 30 days after the last study treatment.
Time frame: 8 years
Percentage of participants with clinical benefit as assessed by Investigator
Investigators' assessment of clinical benefit will collected through the Investigator confirming that the patient is still benefiting from treatment. This will be evaluated and tabulated for participants in the Safety Set by treatment group at each visit.
Time frame: 8 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Taken orally, once daily, with food
Taken orally, once daily in a fasted state, 1 or 2 hours before a meal
Pediatric participants receive a body weight adjusted dose of 1.3 mg/kg of pediatric film coated granules with food twice daily (b.i.d.) or 2.6 mg/kg once daily (q.d.) in the morning.
Michigan Med University of Michigan
Ann Arbor, Michigan, United States
RECRUITINGMemorial Sloan Kettering
New York, New York, United States
RECRUITINGOregon Health Sciences University
Portland, Oregon, United States
ACTIVE_NOT_RECRUITINGTexas Oncology
Dallas, Texas, United States
RECRUITINGUni Of TX MD Anderson Cancer Cntr
Houston, Texas, United States
RECRUITINGNovartis Investigative Site
CABA, Buenos Aires, Argentina
RECRUITINGNovartis Investigative Site
Capital Federal, Argentina
RECRUITINGNovartis Investigative Site
Graz, Austria
RECRUITINGNovartis Investigative Site
Vienna, Austria
RECRUITINGNovartis Investigative Site
Rio de Janeiro, Rio de Janeiro, Brazil
RECRUITING...and 74 more locations