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RECRUITING Phase 2

Asciminib as Initial Therapy for Patients With Chronic Myeloid Leukemia in Chronic Phase

NCT05143840 · View on ClinicalTrials.gov ↗

Study Summary

This study is a multicenter Phase 2, non-randomized, open-label single-group frontline study administering asciminib in patients with newly diagnosed Chronic Myeloid Leukemia-Chronic Phase (CML-CP). The aim of this study is to evaluate the efficacy and safety of asciminib in newly diagnosed CML-CP. Patients will receive asciminib 80 mg orally once daily during the single asciminib phase. Response is determined by PCR (polymerase chain reaction) blood test during the study. Patients who have not achieved a response after 24 months (but no later than 36 months) of single agent asciminib will be offered the addition of a low dose tyrosine kinase inhibitor (low-TKI) namely dasatinib, imatinib, or nilotinib at the investigator's discretion. The following doses of the TKIs will be used: 1. Dasatinib 50 mg daily 2. Imatinib 300 mg daily 3. Nilotinib 300 mg daily Patients will discontinue study treatment if they experience disease progression, or unacceptable toxicity.

Interventions

  • DRUG Single Agent Asciminib
  • COMBINATION_PRODUCT Low TKI
  • OTHER Elective Free Treatment

Study Locations (7)

Georgia

  • Winship Cancer Institute Emory University — Atlanta
  • Georgia Cancer Center at Augusta University — Augusta

New York

  • Roswell Park Comprehensive Cancer Center — Buffalo
  • Memorial Sloan Kettering Cancer Center — New York

Michigan

  • Karmanos Cancer Institute — Detroit

Utah

  • Huntsman Cancer Institute — Salt Lake City

Wisconsin

  • Froedtert Hospital & the Medical College of Wisconsin — Milwaukee

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2022-04-22
Est. Completion 2032-02
Phase Phase 2

Sponsor

Augusta University

126 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05143840

The ClinicalTrials.gov registry entry for NCT05143840 describes a study currently listed as 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 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Augusta University, which has 126 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Leukemia, Myeloid appearing as the primary indexed condition, and to 3 interventions — of which Single Agent 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: NCT05143840 reports 7 study locations spanning 5 distinct geographic areas — top geographies include Georgia, New York, Michigan. 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 NCT05143840 about?

NCT05143840 is a clinical study titled "Asciminib as Initial Therapy for Patients With Chronic Myeloid Leukemia in Chronic Phase". This study is a multicenter Phase 2, non-randomized, open-label single-group frontline study administering asciminib in patients with newly diagnosed Chronic Myeloid Leukemia-Chronic Phase (CML-CP). The aim of this study is to evaluate the efficacy and safety of asciminib in newly diagnosed CML-CP. ...

What is the current status of trial NCT05143840?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2022-04-22. Estimated completion is 2032-02.

What conditions does trial NCT05143840 study?

This clinical trial studies the following conditions: Leukemia, Myeloid, Chronic Myeloid Leukemia, Chronic Phase, Leukemia,Myeloid, Chronic, Adult CML. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05143840?

The interventions under investigation include: Single Agent Asciminib (DRUG), Low TKI (COMBINATION_PRODUCT), Elective Free Treatment (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05143840?

This trial is sponsored by Augusta University, which has 126 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05143840 being conducted?

This trial has 7 study locations across Georgia, Michigan, New York, Utah, Wisconsin. 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