Asciminib for Chronic Myeloid Leukemia After Prior Treatment Discontinuation
This study is for people with chronic myeloid leukemia (CML) in chronic phase who have tried to stop their tyrosine kinase inhibitor (TKI) medication before, but their cancer returned. You must have restarted the same TKI you were on before. The study will test if a treatment with asciminib, sometimes combined with your current TKI (imatinib, nilotinib, or dasatinib), can help you achieve a "treatment-free remission" again. This means you would be able to stop taking medication for your CML. Researchers will measure how many people are able to stay off treatment for one year after stopping the study medications. This study is currently recruiting between 47 and 51 participants.
- Study design
- This is a single-arm Phase II study, meaning all participants will receive the same treatment. It plans to enroll a minimum of 47 and a maximum of 51 participants.
- What's involved
- You will take asciminib, possibly with a TKI, for about 12 months. After this, if you meet certain requirements, you will stop treatment and be monitored for up to three years, with additional follow-up for one year.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to three years in the treatment-free remission phase, with an additional year of long-term follow-up.
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NCT04838041
Protocol Number: HJKC3-0003. Treatment Free Remission After Asciminib Based Therapy in Chronic Phase Chronic Myeloid Leukemia (CP-CML) Patients Who Relapsed After a Prior Attempt at TKI Discontinuation
Recruiting
PHASE2Ages 18+InterventionalTreatmentMedical College of WisconsinInvestigator-initiated
~51 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:Asciminib 40 MGAsciminib 40 MG Twice DailyAsciminib 80 MG dailyImatinibNilotinibDasatinib
At a glance
Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
One-year "second" treatment-free remission.
Measured over 1 year after stopping treatment
Conditions
Where it's being run
5 sites across 4 statesNew York2
Michigan1
Utah1
Wisconsin1
Study leadership
- Ehab Atallah, MD · PRINCIPAL_INVESTIGATOR · Medical College of Wisconsin
- Michael J. Mauro, MD · STUDY_CHAIR · Memorial Sloan Kettering Cancer Center
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Stable molecular response (MR4; \< 0.01% IS) for \> 2 years (with allowance for a two-week variance), as documented on at least four tests, performed at least three months apart (e.g., If a patient has had \>4 PCR tests performed during the two years leading up to their initial TKI discontinuation, any value between 0.01 and 0.05% IS is considered a stable result, however, at least four tests must be \< 0.01% IS. If any results are \>0.05% IS, tests must have been repeated within one month and be less than 0.01% IS and stable.
Treatment with one of the following FDA approved TKIs; imatinib, dasatinib, nilotinib at any dose for a minimum of approximately three years (allowance of a four-week variance) prior to discontinuing TKIs.
Has been on any number of TKIs, but has not been resistant to any TKI (changes made for intolerance are allowed). 6. Must have relapsed (defined as loss of major molecular response (MMR), RQ-PCR for BCR::ABL1 \>0.1% IS after first attempted TKI discontinuation. 7. After first failed TFR attempt, must have a minimum duration of one year of retreatment with TKI, and must plan to remain on that TKI or switch to asciminib for a minimum of 12 months during the consolidation treatment phase. 8. Current TKI must be the same as the TKI being taken prior to the initial TFR attempt (e.g., if patient is on imatinib prior to first TFR attempt, they should be on imatinib at time of enrollment on this study). 9. Eastern Cooperative Oncology Group (ECOG) performance status 0-3. 10. Must have a RQ-PCR for BCR::ABL1 \< 0.0032% IS (MR4.5) reported by the trial designated central lab at the time of study enrollment. 11. Lipase ≤ 1.5 x upper limit of normal (ULN). For lipase \> ULN - ≤ 1.5 x ULN, value should be considered not clinically significant and not associated with risk factors for acute pancreatitis. 12. eGFR ≥ 30 mL/min as calculated using the 2021 chronic kidney disease epidemiology (CKD-EPI) creatinine equation (https://www.kidney.org/professionals/kdoqi/gfr\_calculator) 13. Female patients must meet one of the following:
Postmenopausal for at least one year before the screening visit,
Surgically sterile
If they are of childbearing potential, agree to practice two effective methods of contraception from the time of signing of the informed consent form through 90 days after the last dose of study drug,
Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable
Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \[e.g., calendar, ovulation, symptothermal, postovulation methods\] and withdrawal are not acceptable contraception methods.) 14. Male patients, even if surgically sterilized (i.e., status post vasectomy), must agree to one of the following:
Practice effective barrier contraception during the entire study treatment period and through 90 days after the last study drug dose.
Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable.
Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \[e.g., calendar, ovulation, symptothermal, postovulation methods\] and withdrawal are not acceptable methods of contraception.)
What this trial measures
- One-year "second" treatment-free remission.1 year after stopping treatment
This will be measured by the number of subjects who achieve one-year treatment-free remission after 12 months of asciminib based therapy. These subjects have previously failed a first treatment free remission attempt.