Chronic Myeloid Leukemia, Chronic PhasePhase 2AsterANCT06368414
A Study of Treatment-free Remission in Chronic Phase Chronic Myeloid Leukemia
A Phase 2 study testing Asciminib in people with Chronic Myeloid Leukemia, Chronic Phase, run by Korean Society of Hematology at 1 site in South Korea.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia, Chronic Phase
- What is being tested?
- Asciminib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Mar 2024to 31 Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 19 year or older
- CP-CML patients who are taking current TKIs (imatinib, nilotinib or dasatinib) for 5 years or more
- Patients who have failed maintaining MR3.0 after 1 or more cessation trial of TKIs.
- Patients who regained MR3.0 or deeper molecular response by TKIs retrial after TKI cessation failure at the time of screening
- Taking TKIs over 12 weeks for the retrial of TKIs after TKI cessation failure
- Patients who agree with stopping asciminib and TKIs after maintaining 23 year-duration of MR4.5
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- 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
- Patients who can sign the informed consent of their own free will
Who cannot join
- Patients who experienced grade 3 or higher adverse events with TKIs (imatinib, dasatinib, and nilotinib).
- Patients who are receiving any other investigational agents.
- Patients who currently have uncontrolled infections
- Patients who previously received Chimeric antigen receptor T-cell (CAR-T cell) therapy, allogeneic hematopoietic stem cell transplantation (allo-HSCT) or biologic therapy.
- Patients with clinically significant cardiovascular disease or gastrointestinal dysfunction.
- Patients who have a history of thromboembolic episodes within 3 months prior to the study enrollment.
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- Patients with active hepatitis B or C with uncontrolled disease activity.
- Patients who have active malignancies requiring treatment other than CML.
- Patients with any severe and/or uncontrolled medical conditions or other conditions that could adversely impact on patients' ability to participate in the study.
- Patients with psychiatric illness/social situations that would limit compliance with study requirements.
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Gachon University Gil Medical Center
Incheon, Incheon, 21565
Eunju Park, 01085338019, gilhema01@gmail.com
About this study
Official title: A Study of Treatment-free Remission in Chronic Phase Chronic Myeloid Leukemia in Combination With Asciminib and Tyrosine Kinase Inhibitors
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
Read the detailed description
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.
- Conditions
- Chronic Myeloid Leukemia, Chronic Phase
- Being tested
- Asciminib
- Medical subject headings
- Leukemia, Myeloid, Chronic-Phase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AsciminibDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Asciminib arm | Other | Not described Receives: Drug: Asciminib |
What is being measured
The primary outcome is the main question the study is designed to answer.
MR3.0 or less by 1 year
To evaluate the cumulative incidence of sustained MR3.0 or less by 1 year of cessation of TKI and asciminib
Measured: by 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start11 Mar 2024
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Myeloid Leukemia, Chronic PhaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korean Society of Hematology
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Hawk Kim, Study chair, Korean Society of Hematology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368414
- Sponsor's protocol ID
- KCMLWP-2021-04
- Acronym
- AsterA
- Status last verified
- Apr 2026
- First submitted
- 11 Apr 2024
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Levey AS, Coresh J, Greene T, Stevens LA, Zhang YL, Hendriksen S, Kusek JW, Van Lente F; Chronic Kidney Disease Epidemiology Collaboration. Using standardized serum creatinine values in the modification of diet in renal disease study equation for estimating glomerular filtration rate. Ann Intern Med. 2006 Aug 15;145(4):247-54. doi: 10.7326/0003-4819-145-4-200608150-00004.
PubMed 16908915
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Treatment-free Remission in Chronic Phase Chronic Myeloid Leukemia in Combination With Asciminib and Tyrosine Kinase Inhibitors
- ClinicalTrials.gov ID
- NCT06368414
- Acronym / sponsor ID
- AsterA / KCMLWP-2021-04
- Conditions
- Chronic Myeloid Leukemia, Chronic Phase
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Korean Society of HematologyResearch network
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asciminib arm | Other | Drug: Asciminib |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 19 year or older
- CP-CML patients who are taking current TKIs (imatinib, nilotinib or dasatinib) for 5 years or more
- Patients who have failed maintaining MR3.0 after 1 or more cessation trial of TKIs.
- Patients who regained MR3.0 or deeper molecular response by TKIs retrial after TKI cessation failure at the time of screening
- Taking TKIs over 12 weeks for the retrial of TKIs after TKI cessation failure
Key exclusion criteria (11 listed)
- Patients who experienced grade 3 or higher adverse events with TKIs (imatinib, dasatinib, and nilotinib).
- Patients who are receiving any other investigational agents.
- Patients who currently have uncontrolled infections
- Patients who previously received Chimeric antigen receptor T-cell (CAR-T cell) therapy, allogeneic hematopoietic stem cell transplantation (allo-HSCT) or biologic therapy.
- Patients with clinically significant cardiovascular disease or gastrointestinal dysfunction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Asciminibthat 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 | Drug | Asciminib arm |
Primary outcome
MR3.0 or less by 1 year
Time frame: by 1 year
To evaluate the cumulative incidence of sustained MR3.0 or less by 1 year of cessation of TKI and asciminib
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Background: PubMed 16908915Levey AS, Coresh J, Greene T, Stevens LA, Zhang YL, Hendriksen S, Kusek JW, Van Lente F; Chronic Kidney Disease Epidemiology Collaboration. Using standardized serum creatinine values in the modification of diet in renal disease study equation for estimating glomerular filtration rate. Ann Intern Med. 2006 Aug 15;145(4):247-54. doi: 10.7326/0003-4819-145-4-200608150-00004.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hawk Kim study chair
Korean Society of Hematology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Asciminib in people with Chronic Myeloid Leukemia, Chronic Phase, run by Korean Society of Hematology at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hawk Kim (82-10-8533-8019, ksh.cml.wp@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MR3.0 or less by 1 year (time frame: by 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06368414, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.