Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 3 study of Philadelphia Chromosome-Positive Chronic Myeloid Leukemia, sponsored by Novartis Pharmaceuticals.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
TTDAE is defined as the interval from the date of first study treatment administration to the date of discontinuation of study treatment due to an adverse event (AE). The comparison between the asciminib and nilotinib treatment arms is performed using a cause-specific hazard model, in which discontinuations due to AE are considered the event of interest and discontinuations for reasons other than AE are treated as competing risks. The number of participants who discontinued study treatment due t
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 |
What the registry record for NCT05456191 still lists
NCT05456191 is an interventional study that assigns participants to a tested intervention. The registered 568 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% lower).
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 names 20 study sites across 11 states, led by 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05456191's enrollment target sits among peer trials
568 666th of 2000 higher than 1,335 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05472441 · 568 participants · NA
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
- NCT05000645 · 570 participants · NA
Grocery Delivery and Healthy Weight Gain Among Low-income Pregnant Young Women
- NCT06239844 · 570 participants · NA
Navigating Together for Equitable Asthma Management for Children in Families Who Communicate in Language Other Than English
- NCT06701903 · 570 participants · Phase 2
Study of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI