Study on Treatment-Free Remission After Combination Therapy with Asciminib and Tyrosine Kinase Inhibitors in Chronic Phase Chronic Myeloid Leukemia Patients

Sponsor: Medical College of Wisconsin

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04838041

Provider View

This clinical trial is exploring whether a combination of the drug Asciminib and Tyrosine Kinase Inhibitors (TKI) can help patients with chronic phase chronic myeloid leukemia (CP-CML) achieve a treatment-free remission after previously relapsing when trying to stop TKI treatment.

Patient Parameters

Program Overview

This study involves patients with chronic phase chronic myeloid leukemia (CP-CML) who have previously tried to stop taking Tyrosine Kinase Inhibitors (TKI) but experienced a relapse. The trial will test if combining Asciminib with TKI can help these patients achieve a treatment-free remission. Participants will take the combination therapy for about a year, and if successful, they will stop all treatment and be monitored for up to three years to see if they can remain in remission without medication.

Description

In this study, eligible patients will start taking Asciminib along with their current Tyrosine Kinase Inhibitor (TKI) on the first day of the treatment phase. This combination therapy will last for 12 cycles, with each cycle being about 28 days long, totaling approximately one year. After completing the 12 cycles, patients who meet specific criteria will enter the treatment-free remission (TFR) phase, where they will stop taking both Asciminib and TKI. During the TFR phase, patients will be closely monitored without treatment for up to three years to see if they can maintain remission. The main goal is to determine the rate of patients who can remain in remission for 12 months after stopping the combination therapy. The entire study participation will last about five years, including one year of combination therapy, three years in the TFR phase, and one year of follow-up.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Able to provide informed consent.
  • Diagnosed with chronic phase chronic myeloid leukemia (CP-CML) with specific genetic markers.
  • Previously attempted to stop TKI treatment once under a doctor's guidance.
  • Must have had a stable molecular response for over two years before the first attempt to stop TKI.
  • Treated with an FDA-approved TKI for at least three years before stopping.
  • Relapsed after the first attempt to stop TKI, defined by specific test results.
  • Retreated with the same TKI for at least one year after relapse and plan to continue it during the study.
  • Current TKI must be the same as before the first attempt to stop.
  • ECOG performance status of 0-3.
  • Specific test results required at study enrollment.
  • Female participants must meet specific reproductive health criteria and agree to use effective contraception.
  • Male participants must agree to use effective contraception or practice abstinence.

Exclusion Criteria

  • History of advanced phases of CML.
  • Another active cancer requiring treatment.
  • Recent or chronic pancreatitis.
  • Previous treatment with Asciminib.
  • Low blood cell counts or hemoglobin levels.
  • High liver enzyme levels.
  • Poor kidney function.
  • High bilirubin levels unless due to a specific condition.
  • Pregnant or breastfeeding.
  • Unable to comply with study requirements.
  • Recent use of another investigational drug.
  • Serious medical or psychiatric conditions.
  • Previous stem cell transplant.
  • Specific heart test results.
  • Active hepatitis B infection.

Eligibility for TFR Phase:

  • Stable molecular response documented on tests while on combination therapy.
  • Specific test results required before entering TFR phase.
  • ECOG performance status of 0-3.
  • Completion of 12 cycles of combination therapy.

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