Phase II Study of Asciminib for Second-line Treatment of Chronic Phase Chronic Myeloid Leukemia

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT06629584

Provider View

This clinical trial is testing the drug asciminib as a second-line treatment for patients with chronic phase chronic myeloid leukemia (CML) who have previously been treated with one type of TKI therapy.

Patient Parameters

Program Overview

This study is open to patients who have chronic phase chronic myeloid leukemia (CML) and have already tried one type of treatment called TKI therapy. The main goal is to see how well the drug asciminib works in achieving a major molecular response (MMR) at 12 months. Researchers will also look at other outcomes like complete cytogenetic response (CCyR), safety, and survival rates.

Description

The primary goal of this study is to find out how many patients achieve a major molecular response (MMR) at 12 months after starting treatment with asciminib. Secondary goals include estimating the number of patients who achieve complete cytogenetic response (CCyR) and other levels of molecular response at different time points, assessing the safety and tolerability of asciminib, and evaluating survival rates and adverse events. The study will also explore patient-reported outcomes and the development of resistance mutations.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a diagnosis of chronic phase chronic myeloid leukemia (CML) that is positive for certain genetic markers (Ph-positive or BCR-ABL-positive).
  • Have been treated with one previous line of TKI therapy.
  • Have experienced treatment failure, such as not achieving certain response levels at specific times or losing response during TKI treatment.
  • Have a performance status score of 2 or less, indicating they are able to carry out daily activities with some limitations.
  • Have adequate organ function based on specific blood tests.
  • Women of childbearing potential and men must agree to use effective contraception during the study and for a period after treatment.

Exclusion Criteria

  • Have a history of a specific mutation known as T315I.
  • Have severe heart conditions, such as recent heart attack or uncontrolled heart rhythm problems.
  • Have a prolonged QT interval on an ECG, which is a measure of heart rhythm.
  • Have active infections like HIV or Hepatitis B or C.
  • Have conditions that affect the absorption of oral medications.
  • Are pregnant, breastfeeding, or not willing to use contraception if of childbearing potential.
  • Have a history of pancreatitis or low blood cell counts.
  • Have had another active cancer within the last two years, except for certain skin cancers.
  • Have any other significant medical or psychiatric conditions that could affect participation in the study.
  • Must have stopped previous leukemia treatments at least 48 hours before starting the study, except for hydroxyurea, which can be used right before the study.

Locations

FACILITYZIPCITYSTATE
The University of Texas MD Anderson Cancer Center77030HoustonTexas

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