RecruitingPhase 2NCT06514534

Open-label Study of Asciminib for CML-CP or CML-AP Patients With T315I Mutation Who Are Resistant, Intolerant or Ineligible to Ponatinib.

A Phase II, Multi-center, Prospective, Open-label Study of Asciminib in Patients With Chronic Myeloid Leukemia in Chronic Phase (CML-CP) or Accelerated Phase (CML-AP) With T315I Mutation Who Are Resistant, Intolerant or Ineligible to Ponatinib.

Sponsor

Novartis Pharmaceuticals

Enrollment

20 participants

Start Date

Feb 18, 2025

Study Type

INTERVENTIONAL

Conditions

Chronic Myeloid Leukemia (CML)

Summary

The objective of this Phase II study is to assess the potential of asciminib in managing CML-CP or CML-AP in patient carrying the T315I mutation. The presence of this mutation introduces treatment difficulties due to the limited available options. The study seeks to collect additional data on the effectiveness and safety of asciminib for these patients. By determining the drug's capacity to manage the disease and enhance patients outcomes, the study is designed to fill the unmet medical need and potentially offer a new therapeutic path for patients at a treatment deadlock.

Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is testing asciminib, a targeted therapy, for people with chronic myeloid leukemia (CML) who have a specific drug-resistant mutation called T315I and whose disease has not responded to or is not suitable for another targeted drug called ponatinib. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of CML in chronic or accelerated phase - Your tumor has been confirmed to have the T315I mutation - You have had at least one prior TKI (targeted therapy) and are resistant, intolerant, or ineligible for ponatinib - You have never been treated with asciminib or another allosteric TKI - Your BCR::ABL1 gene rearrangement is detectable and measurable **You may NOT be eligible if...** - You have previously received a bone marrow transplant from a donor (allogeneic) - You have significant heart problems or heart rhythm abnormalities - You have severe uncontrolled medical conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGABL001/Asciminib

The study treatment for this clinical trial is an investigational drug called asciminib, which is marketed under the brand name Scemblix®. Asciminib is a compound that is being evaluated for its efficacy and safety in the treatment of the target condition. The minimum dose of asciminib to be administered in this study is 200 mg, while the maximum dose is 400 mg. The dose is planned as 200 mg twice a day (BID). The drug will be administered orally, allowing for convenient and non-invasive administration.