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NCT05456191 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study of Philadelphia Chromosome-Positive Chronic Myeloid Leukemia, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 568
- Enrollment target
- 20
- Study locations
NCT05456191 is a Phase 3 study of Philadelphia Chromosome-Positive Chronic Myeloid Leukemia that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 568 participants. The trial reports 20 study locations across 11 states.
The verdict
NCT05456191, a Phase 3 study of Philadelphia Chromosome-Positive Chronic Myeloid Leukemia, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 568 participants
- Enrollment target
- 20
- Study locations
Study Summary
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).
Conditions Studied
Interventions
- DRUG Nilotinib
- DRUG Asciminib
Study Locations (20)
Other
- Novartis Investigative Site - Buenos Aires
- Novartis Investigative Site - Buenos Aires
- Novartis Investigative Site - Caba
- Novartis Investigative Site - CABA
- Novartis Investigative Site - Pleven
- Novartis Investigative Site - Plovdiv
- Novartis Investigative Site - Sofia
- Novartis Investigative Site - Sofia
- Novartis Investigative Site - Varna
Texas
- Texas Oncology P A - Bedford
- Texas Oncology PA Bedford - Bedford
Colorado
- Rocky Mountain Cancer Centers - Denver
Illinois
- Illinois Cancer Care - Peoria
Minnesota
- Regions Hospital - Saint Paul
North Carolina
- Messino Cancer Centers - Asheville
Ohio
- Oncology Hematology Care Inc - Cincinnati
Oregon
- Williamette Cancer Center - Eugene
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 568 participants |
| Start Date | 2022-11-21 |
| Est. Completion | 2031-07-07 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05456191
The ClinicalTrials.gov registry entry for NCT05456191 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 568 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Philadelphia Chromosome-Positive Chronic Myeloid Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Nilotinib is the first listed.
NCT05456191 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Other, Texas, Colorado.
Frequently Asked Questions
What is clinical trial NCT05456191 about?
NCT05456191 is a clinical study titled "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)". 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 (P...
What is the current status of trial NCT05456191?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 568 participants. The study started on 2022-11-21. Estimated completion is 2031-07-07.
What conditions does trial NCT05456191 study?
This clinical trial studies the following conditions: Philadelphia Chromosome-Positive Chronic Myeloid Leukemia.
What interventions are being tested in trial NCT05456191?
The interventions under investigation include: Nilotinib (DRUG), Asciminib (DRUG).
Who is sponsoring clinical trial NCT05456191?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05456191 being conducted?
This trial has 20 study locations across Colorado, Illinois, Minnesota, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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