A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP
Running, not enrolling · Phase 3
Conditions studied: Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive
In brief
The study is designed to compare the efficacy of asciminib 80 mg QD versus Investigator selected Tyrosine Kinase Inhibitor (TKI) for the treatment of newly diagnosed, previously untreated patients with Ph+ CML-CP. The Investigator selected TKI will be one of the following treatment options for first-line treatment of CML-CP - imatinib 400 mg QD or nilotinib 300 mg BID or dasatinib 100 mg QD or bosutinib 400 mg QD. This study has three periods: 1. Treatment period for all randomized participants, 2. Optional Treatment-Free Remission (TFR) period only for participants meeting TFR eligibility criteria and 3. Treatment Re-Initiation (TRI) period only for participants who relapsed after TFR attempt.
Key facts
- Study ID
- NCT04971226
- Run by
- Novartis Pharmaceuticals
- People needed
- 405
- Starts
- 2021-10-06
- Expected to finish
- 2031-01-18
- Last updated by the study team
- 2026-06-08
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Florida Cancer Specialists — Fort Myers, Florida, United States
- Florida Cancer Specialists Pan — Tallahassee, Florida, United States
- University of Kentucky — Lexington, Kentucky, United States
- Uni of Massachusetts Medical Center — Worcester, Massachusetts, United States
- Wake Forest University Baptist Medical Center — Winston-Salem, North Carolina, United States
- Williamette Cancer Center — Eugene, Oregon, United States
- Oregon Health Sciences University — Portland, Oregon, United States
- Avera Cancer — Sioux Falls, South Dakota, United States
- Chattanooga Onc And Hem Assoc PC — Chattanooga, Tennessee, United States
- Texas Oncology — Amarillo, Texas, United States
- Texas Oncology-Baylor USO — Dallas, Texas, United States
- Texas Oncology — Dallas, Texas, United States
- Novartis Investigative Site — Kingswood, New South Wales, Australia
- Novartis Investigative Site — Port Macquarie, New South Wales, Australia
- Novartis Investigative Site — Adelaide, South Australia, Australia
- Novartis Investigative Site — Southport, Australia
- Novartis Investigative Site — Linz, Upper Austria, Austria
- Novartis Investigative Site — Leuven, Vlaams Brabant, Belgium
- Novartis Investigative Site — Brussels, Belgium
- Novartis Investigative Site — Varna, Bulgaria
- Novartis Investigative Site — Calgary, Alberta, Canada
- Novartis Investigative Site — Hamilton, Ontario, Canada
- Novartis Investigative Site — Ottawa, Ontario, Canada
- Novartis Investigative Site — Toronto, Ontario, Canada
- Rocky Mountain Cancer Centers — Denver, Colorado, United States
Full record on ClinicalTrials.gov
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