A Phase III Study of Asciminib versus Bosutinib in Patients with Chronic Myelogenous Leukemia in Chronic Phase

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Full Title

A Phase 3, Multi-Center, Open-Label, Randomized Study of Oral ABL001 (Asciminib) Versus Bosutinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase (CML-CP), Previously Treated With 2 or More Tyrosine Kinase Inhibitors

Purpose

Medications called tyrosine kinase inhibitors (TKIs) are standard treatments for chronic myelogenous leukemia (CML). Examples include imatinib, nilotinib, dasatinib, bosutinib, and ponatinib. Sometimes CML does not respond to these treatments, responds partially, or grows despite them, and sometimes the side effects of therapy limit the chance of a full response. In this study, researchers are comparing the investigational drug asciminib with bosutinib in patients with CML in chronic phase (CML-CP) that persists despite prior treatment with two different TKIs.

Bosutinib and asciminib are both inhibitors of BCR-ABL, an abnormal protein in CML. Because bosutinib and asciminib inhibit BCR-ABL in different ways, investigators in this study are comparing them to see which works better in patients with previously treated CML-CP.

Two-thirds of the patients will be randomly assigned to receive asciminib and one-third will receive bosutinib. Both medications are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have CML-CP that persists despite two prior regimens of TKI therapy.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Michael Mauro at 212-639-3107.

Protocol

19-043

Phase

III

Disease Status

Relapsed or Refractory

Investigator