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NCT05384587 · ClinicalTrials.gov registry record · Phase 2
Asciminib Monotherapy, With Dose Escalation, for 2nd and 1st Line Chronic Myelogenous Leukemia
A Phase 2 study of Chronic Myelogenous Leukemia - Chronic Phase, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
- 20
- Study locations
NCT05384587: Active Phase 2 study of Chronic Myelogenous Leukemia - Chronic Phase, sponsored by Novartis Pharmaceuticals.
NCT05384587 is a Phase 2 study of Chronic Myelogenous Leukemia - Chronic Phase that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 34 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05384587, a Phase 2 study of Chronic Myelogenous Leukemia - Chronic Phase, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
- 20
- Study locations
Study Summary
This will be a multicenter Phase II open-label study of asciminib in CML-CP patients who have been previously treated with one prior ATP- binding site TKI with discontinuation due to treatment failure, warning or intolerance. (2L patient cohort). In addition, newly diagnosed CML-CP patients who may have received up to 4 weeks of prior TKI are included in a separate 1L patient cohort.
Primary Outcome
MMR is defined as BCR::ABL1IS ≤ 0.1%. A patient will be counted as having achieved MMR at 12 month if he/she meets the MMR criterion at 12 month.
Conditions Studied
Interventions
- DRUG asciminib
Study Locations (20)
California
- Onco Inst of Hope and Innovation - Cerritos
- City of Hope National Medical - Duarte
- UCSF Fresno Internal Medicine - Fresno
- Virginia K Crosson Cancer Center - Fullerton
- UCLA - Los Angeles
- Alta Bates Summit Medical Center - Oakland
- Lundquist Inst BioMed at Harbor - Torrance
Florida
- Florida Cancer Specialists - Fort Myers
- Baptist MD Anderson Cancer Center - Jacksonville
- Florida Cancer Specialists-North - St. Petersburg
- Florida Cancer Specialists East - Stuart
Arizona
- City of Hope Phoenix - Scottsdale
- USO Arizona Oncology - Tucson
Connecticut
- Yale University School Of Medicine - New Haven
- The Stamford Hospital - Stamford
Georgia
- City Of Hope Atlanta - Atlanta
- Emory University School of Medicine Winship Cancer Institute - Atlanta
Alabama
- University of Alabama at Birmingham - Birmingham
Alaska
- Alaska Oncology and Hematology - Anchorage
Colorado
- Rocky Mountain Cancer Centers - Boulder
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2022-11-11 |
| Est. Completion | 2027-10-17 |
| Phase | Phase 2 |
What the registry record for NCT05384587 still lists
NCT05384587 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 1 condition, with Chronic Myelogenous Leukemia - Chronic Phase appearing as the primary indexed condition, and to 1 intervention - of which asciminib is the first listed.
NCT05384587 names 20 study sites across 8 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT05384587 about?
NCT05384587 is a clinical study titled "Asciminib Monotherapy, With Dose Escalation, for 2nd and 1st Line Chronic Myelogenous Leukemia". This will be a multicenter Phase II open-label study of asciminib in CML-CP patients who have been previously treated with one prior ATP- binding site TKI with discontinuation due to treatment failure, warning or intolerance. (2L patient cohort). In addition, newly diagnosed CML-CP patients who may ...
What is the current status of trial NCT05384587?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2022-11-11. Estimated completion is 2027-10-17.
What conditions does trial NCT05384587 study?
This clinical trial studies the following conditions: Chronic Myelogenous Leukemia - Chronic Phase.
What interventions are being tested in trial NCT05384587?
The interventions under investigation include: asciminib (DRUG).
Who is sponsoring clinical trial NCT05384587?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05384587 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05384587's enrollment target sits among peer trials
34 1539th of 2000 higher than 448 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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