A Study of Treatment-free Remission in Chronic Phase Chronic Myeloid Leukemia

Study Purpose

To evaluate the efficacy of asciminib adding on tyrosine-kinase inhibitors (TKI) to achieve treatment-free remission (TFR) in chronic myeloid leukemia (CML) patients in chronic phase who failed prior cessation study of TKI

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	19 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. 19 year or older. 2. CP-CML patients who are taking current TKIs (imatinib, nilotinib or dasatinib) for 5 years or more. 3. Patients who have failed maintaining MR3.0 after 1 or more cessation trial of TKIs. 4. Patients who regained MR3.0 or deeper molecular response by TKIs retrial after TKI cessation failure at the time of screening. 5. Taking TKIs over 12 weeks for the retrial of TKIs after TKI cessation failure. 6. Patients who agree with stopping asciminib and TKIs after maintaining 23 year-duration of MR4.5. 7. Adequate end organ function as defined by:

- Total bilirubin (TBL) < 3 x upper limit of normal (ULN); patients with Gilbert's syndrome may only be included if TBL ≤ 3.0 x ULN or direct bilirubin ≤ 1.5 x ULN.

- Creatinine clearance (ClCr) ≥ 30 mL/min as calculated using Cockcroft-Gault formula.

- Serum lipase ≤ 1.5 x ULN.

For serum lipase > ULN

- ≤ 1.5 x ULN, value must be considered not clinically significant and not associated with risk factors for acute pancreatitis.

8. Patients who can sign the informed consent of their own free will.

Exclusion Criteria:

1. Patients who experienced grade 3 or higher adverse events with TKIs (imatinib, dasatinib, and nilotinib). 2. Patients who are receiving any other investigational agents. 3. Patients who currently have uncontrolled infections. 4. Patients who previously received Chimeric antigen receptor T-cell (CAR-T cell) therapy, allogeneic hematopoietic stem cell transplantation (allo-HSCT) or biologic therapy. 5. Patients with clinically significant cardiovascular disease or gastrointestinal dysfunction. 6. Patients who have a history of thromboembolic episodes within 3 months prior to the study enrollment. 7. Patients with active hepatitis B or C with uncontrolled disease activity. 8. Patients who have active malignancies requiring treatment other than CML. 9. Patients with any severe and/or uncontrolled medical conditions or other conditions that could adversely impact on patients' ability to participate in the study. 10. Patients with psychiatric illness/social situations that would limit compliance with study requirements. 11. Pregnant women are excluded from this study Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with asciminib and TKIs, breastfeeding should be discontinued if the mother is treated with asciminib and TKIs.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06368414
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Korean Society of Hematology
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Hawk Kim
Principal Investigator Affiliation	Korean Society of Hematology
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Chronic Myeloid Leukemia, Chronic Phase

Additional Details

We expect that patients who lost MR3.0 after stopping TKIs, thus failed to maintain treatment-free remission can achieve second sustainable MR4.5 by sustainable MR4.5 for more than 3 years once regained and prolong MRFS by adding asciminib to TKIs. Patients will be restarted on TKIs when they fail sustaining MR3.0 after cessation because restarting TKIs when loss of MR3.0 is reasonable in this situation.

Arms & Interventions

Arms

Other: Asciminib arm

Interventions

Drug: - Asciminib

that patients who lost MR3.0 after stopping TKIs, thus failed to maintain treatment-free remission can achieve second sustainable MR4.5 by sustainable MR4.5 for more than 3 years once regained and prolong MRFS by adding asciminib to TKIs. Patients will be restarted on TKIs when they fail sustaining MR3.0 after cessation because restarting TKIs when loss of MR3.0 is reasonable in this situation

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Hawk Kim

[email protected]

82-10-8533-8019

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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