Stopping Treatment a Second Time After One Year Combination Treatment with Asciminib and Imatinib for Chronic Myeloid Leukemia that Came Back After Previously Trying to Stop Imatinib

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Full Title

Treatment Free Remission After Combination Therapy with Asciminib (ABL001) Plus Tyrosine Kinase Inhibitors (TKI) in Chronic Phase Chronic Myeloid Leukemia (CP-CML) Patients Who Relapsed After a Prior Attempt at TKI Discontinuation

Purpose

Imatinib is a standard long-term therapy for chronic myeloid leukemia (CML). Some people are able to stop taking imatinib after their CML is in remission, but sometimes it comes back and retreatment is needed. In this study, researchers want to see if adding the drug asciminib to imatinib therapy prior to a second attempt at stopping treatment will lead to prolonged treatment-free remission (no evidence of cancer after stopping therapy).

This study is for people with CML who attempted stopping imatinib once before and are considering stopping it for a second time. Asciminib and imatinib are taken orally (by mouth). Both drugs are already used to treat CML.

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have CML that relapsed after one prior attempt at stopping imatinib therapy.
  • Participants must have been back on imatinib treatment for a year or more and achieved a deep remission.
  • No prior treatment with asciminib is permitted.
  • In addition to patients with good physical function, this study is also open to those who are capable of only limited self-care and are confined to a bed or chair for more than half of their normal waking hours.
  • This study is for people age 18 and older.

Contact

For more information and to ask about eligibility for this study, please contact the office of Dr. Michael Mauro at 646-608-3744.

Protocol

22-390

Phase

Phase II (phase 2)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT04838041