Study Comparing Asciminib and Nilotinib for Newly Diagnosed Chronic Myelogenous Leukemia in Adults

Sponsor: Novartis Pharmaceuticals

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05456191

Provider View

This clinical trial is comparing two oral medications, Asciminib and Nilotinib, to see which is better tolerated and more effective for adults newly diagnosed with a specific type of leukemia called Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP).

Patient Parameters

Program Overview

The study aims to find out how well two different oral medications, Asciminib and Nilotinib, work for treating adults who have just been diagnosed with a type of leukemia called Ph+ CML-CP. Participants will be randomly assigned to receive either Asciminib or Nilotinib and will continue treatment until they experience unacceptable side effects, their disease progresses, or they or their doctor decide to stop. After stopping treatment, participants will have a follow-up visit or call about 30 days later. Those who stop treatment early will be monitored for survival and disease progression until the study ends.

Description

This study is a phase IIIb trial conducted at multiple centers. It is open-label, meaning both the participants and the researchers know which treatment is being given. Participants will be randomly assigned to receive either Asciminib (80 mg once daily) or Nilotinib (300 mg twice daily). There will be no switching between the two treatments during the study.

Participants will continue their assigned treatment until they experience unacceptable side effects, their leukemia progresses, or they or their doctor decide to stop. A follow-up visit or call will occur about 30 days after stopping treatment. If participants stop treatment early, they will still be followed for survival and disease progression until the study concludes.

Eligibility Criteria

Inclusion Criteria

  • Adults diagnosed with Ph+ CML-CP within the last 3 months.
  • Confirmation of the Philadelphia chromosome in their leukemia cells.
  • Meet specific blood and bone marrow criteria, such as having less than 15% blasts in blood and bone marrow.
  • Have a specific genetic marker (BCR::ABL1 transcript) that can be measured by a central lab.
  • Have a performance status score of 0 or 1, indicating they are fully active or have some restrictions but can still perform light work.
  • Have adequate organ function based on specific blood tests.
  • Have normal or corrected levels of potassium, calcium, and magnesium before starting the study.

Exclusion Criteria

  • Previous treatment for CML with other cancer drugs, except for hydroxyurea or anagrelide.
  • Known cancer spread to the central nervous system.
  • Significant heart problems or abnormal heart rhythms.
  • Severe or uncontrolled medical conditions that could pose safety risks.
  • History of significant bleeding disorders unrelated to cancer.
  • Major surgery within the last 4 weeks or not fully recovered from surgery.
  • History of other active cancers within the last 3 years, except for certain skin cancers or carcinoma in situ.
  • History of pancreatitis or severe liver disease.
  • Chronic hepatitis B or C infection.
  • HIV infection unless well-controlled with medication.

Other specific criteria may apply as defined in the study protocol.

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