Study on Asciminib Monotherapy with Dose Escalation for First and Second Line Treatment of Chronic Myelogenous Leukemia

Sponsor: Novartis Pharmaceuticals

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05384587

Provider View

This clinical trial is testing the drug asciminib for patients with chronic myelogenous leukemia (CML) who have either been newly diagnosed or have previously tried one other treatment that didn't work or caused side effects. The study aims to find out if asciminib can be an effective treatment option.

Patient Parameters

Program Overview

This study is a Phase II trial conducted at multiple centers to evaluate the effectiveness of asciminib in patients with chronic myelogenous leukemia in the chronic phase (CML-CP). It includes two groups: one for patients who have tried one previous treatment that didn't work or caused side effects, and another for newly diagnosed patients who have had up to four weeks of prior treatment. The study will assess how well asciminib works and its safety over a period of up to 104 weeks, with a follow-up period to monitor safety.

Description

The trial is divided into three parts: a screening and baseline period lasting up to 28 days, an active treatment period lasting up to 104 weeks, and a safety follow-up period of 30 days.

For patients who have tried one previous treatment (2L patients), 92 participants without a specific mutation (T315I) will be included. They will be tested for this mutation at the start and excluded if it is present.

For newly diagnosed patients (1L patients), up to 90 participants will be enrolled. Enrollment will stop when either 90 patients are enrolled or when 60 patients are enrolled and the 2L group is full.

All participants will start with a dose of 80 mg of asciminib once a day. After six months, if their leukemia levels are low enough, they will continue on the same dose. If not, their dose will increase to 200 mg once a day.

After 12 months, patients will be evaluated to see if their leukemia is under control. Depending on the results, they may continue on the same dose, increase their dose, or switch to another treatment if necessary.

Participants must provide informed consent before any study procedures begin.

Eligibility Criteria

Inclusion Criteria

  • Must provide signed informed consent before participating.
  • Diagnosed with chronic myelogenous leukemia in the chronic phase (CML-CP), with no previous advanced phases.
  • Aged 18 years or older.
  • Have a performance status score of 0, 1, or 2, indicating good overall health.
  • Have adequate organ function based on specific medical tests.
  • For patients with mild to moderate kidney or liver issues, certain lab values must be within specified limits.
  • For the 2L group: Must have experienced treatment failure or intolerance to one previous treatment.
  • For the 1L group: Must be newly diagnosed and have had up to four weeks of prior treatment with specific drugs.

Exclusion Criteria

  • Have been treated with two or more previous drugs for CML (for 2L group) or more than four weeks of one drug (for 1L group).
  • Have been treated with asciminib before.
  • Have a specific mutation (T315I) at any time before the study.
  • Have had a second chronic phase of CML after progressing to advanced phases.
  • Have had a stem cell transplant or plan to have one.
  • Have certain heart conditions or abnormalities.
  • Have a history of pancreatitis within the past year.
  • Have participated in another study within 30 days before this one.
  • Are taking certain medications that cannot be stopped before the study.
  • Are pregnant or breastfeeding.
  • Are not using effective birth control if of childbearing potential.
  • Have other severe or uncontrolled medical conditions.
  • Have had another active cancer within the past three years, except for certain skin cancers.
  • Have a known allergy to the study treatment.

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