Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 2

Asciminib Monotherapy, With Dose Escalation, for 2nd and 1st Line Chronic Myelogenous Leukemia

NCT05384587 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 34 participants
Start Date 2022-11-11
Est. Completion 2027-10-17
Phase Phase 2

Sponsor

Novartis Pharmaceuticals

792 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05384587

The ClinicalTrials.gov registry entry for NCT05384587 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05384587 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05384587?

The interventions under investigation include: asciminib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05384587?

This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial