Phase II Study on the Effectiveness and Safety of Asciminib for Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06236724

Provider View

This clinical trial is exploring whether the drug asciminib can effectively control chronic myeloid leukemia (CML) in its early stages. The study will also look at the safety and effects of this treatment.

Patient Parameters

Program Overview

The aim of this study is to find out if asciminib can help manage chronic myeloid leukemia (CML) in patients who have been recently diagnosed. Researchers will also study the safety of the drug and its effects on the body.

Description

The main goal of this study is to see how many patients achieve a major molecular response (MMR) within 12 months of starting treatment with asciminib. Researchers will also look at other outcomes, such as:

  • The number of patients who achieve a complete cytogenetic response (CCyR) within 12 months.
  • The percentage of patients who have a significant reduction in cancer markers (MR4.5) at various points during the study.
  • The time it takes for the disease to progress and how long patients live without the disease getting worse.
  • The safety of the treatment by monitoring any side effects that occur.
  • The number of patients who maintain a significant reduction in cancer markers (MR4.5) for three years or more.
  • The overall rate of patients achieving MR4.5 over time.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 years or older.
  • Diagnosed with a specific type of chronic myeloid leukemia (CML) in the early chronic phase, within 12 months of diagnosis.
  • May have received certain prior treatments for a short period.
  • Can have additional chromosomal abnormalities if they don't meet criteria for more advanced disease.
  • Must be in good general health with an ECOG performance status of 0 to 2.
  • Must have adequate liver and kidney function based on specific blood tests.
  • Must be able to understand and sign a consent form.
  • Women and men must agree to use effective birth control during the study and for a period after the study ends.
  • Participants with controlled hepatitis B or cured hepatitis C are eligible.
  • Participants with treated brain metastases are eligible if there is no evidence of progression.
  • Participants with other cancers that do not interfere with the study are eligible.
  • Participants with a history of heart disease must have a certain level of heart function to participate.

Exclusion Criteria

  • Have received more than 30 days of certain prior treatments.
  • Have had chemotherapy or radiotherapy recently.
  • Have not fully recovered from side effects of previous cancer treatments.
  • Are taking other experimental drugs.
  • Have allergies to similar drugs.
  • Have severe heart disease or certain heart conditions.
  • Have a history of significant bleeding disorders.
  • Have uncontrolled psychiatric disorders.
  • Have uncontrolled infections or other serious health conditions.
  • Are pregnant or breastfeeding.
  • Are in a more advanced phase of CML or have been diagnosed for more than 12 months.

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