A Study to Investigate Tolerability and Efficacy of Asciminib (Oral) Versus Nilotinib (Oral) in Adult Participants (≥18 Years of Age) With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP)
Running, not enrolling · Phase 3
Conditions studied: Philadelphia Chromosome-Positive Chronic Myeloid Leukemia
In brief
The primary purpose of this study was to assess the tolerability of oral asciminib (80 mg QD) in comparison with that of the second generation (2G) Tyrosine Kinase Inhibitor (TKI) nilotinib (300 mg BID), in adult patients with newly diagnosed Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP).
Key facts
- Study ID
- NCT05456191
- Run by
- Novartis Pharmaceuticals
- People needed
- 568
- Starts
- 2022-11-21
- Expected to finish
- 2031-07-07
- Last updated by the study team
- 2026-05-27
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Illinois Cancer Care — Peoria, Illinois, United States
- Regions Hospital — Saint Paul, Minnesota, United States
- Messino Cancer Centers — Asheville, North Carolina, United States
- Oncology Hematology Care Inc — Cincinnati, Ohio, United States
- Williamette Cancer Center — Eugene, Oregon, United States
- Texas Oncology P A — Bedford, Texas, United States
- Texas Oncology PA Bedford — Bedford, Texas, United States
- Virginia Oncology Associates — Norfolk, Virginia, United States
- Novartis Investigative Site — CABA, Buenos Aires, Argentina
- Novartis Investigative Site — Buenos Aires, Argentina
- Novartis Investigative Site — Buenos Aires, Argentina
- Novartis Investigative Site — Caba, Argentina
- Novartis Investigative Site — CABA, Argentina
- Novartis Investigative Site — Pleven, Bulgaria
- Novartis Investigative Site — Plovdiv, Bulgaria
- Novartis Investigative Site — Sofia, Bulgaria
- Novartis Investigative Site — Sofia, Bulgaria
- Novartis Investigative Site — Varna, Bulgaria
- Novartis Investigative Site — London, Ontario, Canada
- Novartis Investigative Site — Toronto, Ontario, Canada
- Novartis Investigative Site — Brno, Czechia
- Novartis Investigative Site — Plzen Bory, Czechia
- Novartis Investigative Site — Prague, Czechia
- Novartis Investigative Site — Prague, Czechia
- Rocky Mountain Cancer Centers — Denver, Colorado, United States
Full record on ClinicalTrials.gov
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