Leukemia patients who failed stopping meds may get another shot at drug-free remission
NCT ID NCT06368414
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding asciminib to standard tyrosine kinase inhibitors (TKIs) can help people with chronic myeloid leukemia (CML) safely stop all medication and remain in remission. It includes 69 adults who have been on TKIs for at least 5 years but previously failed to stay in remission after stopping treatment. Participants will take asciminib plus their current TKI, then attempt to stop both and be monitored for one year.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 69 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Gachon University Gil Medical Center
RECRUITINGIncheon, Incheon, 21565, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a newer drug outperform the standard for chronic myeloid leukemia?
- Can a new pill rescue patients when standard leukemia drugs stop working?
- Real-World check: Asciminib's performance in Tough-to-Treat CML
- New CML drug combo strategy aims for deeper remission without lifelong side effects
- New daily pill shows promise for Hard-to-Treat leukemia
- New combo aims to free CML patients from daily pills