Protocol Number: HJKC3-0003. 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 ASCIMINIB COMBINATION THERAPY
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What's the purpose of this trial?

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.

This trial is currently open and accepting patients.

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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.

Additional Trial Information

Phase 2

Enrollment: 51 patients (estimated)

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Trial Locations

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Michigan

Barbara Ann Karmanos Cancer Institute Wayne State University

Detroit, MI

Open and Accepting

New Jersey

Memorial Sloan Kettering Monmouth

Middletown, NJ

Open and Accepting

Memorial Sloan Kettering Bergen

Montvale, NJ

Open and Accepting

New York

Memorial Sloan Kettering Cancer Center

New York, NY

Open and Accepting

Utah

Huntsman Cancer Institute University of Utah

Salt Lake City, UT

Open and Accepting

Wisconsin

Medical College of Wisconsin Froedtert Hospital

Milwaukee, WI

Open and Accepting
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