Using standardized serum creatinine values in the modification of diet in renal disease study equation for estimating glomerular filtration rate.
Andrew S Levey, Josef Coresh, Tom Greene...
https://pubmed.ncbi.nlm.nih.gov/16908915Actively Recruiting
Phase 2
Age: 19Years +
All Genders
ID06368414
A Study of Treatment-free Remission in Chronic Phase Chronic Myeloid Leukemia in Combination With Asciminib and Tyrosine Kinase Inhibitors
Led by Korean Society of Hematology · Updated on 2026-04-02
69
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying chronic myeloid leukemia (CML) in the chronic phase, focusing on patients who have not maintained treatment-free remission after stopping tyrosine kinase inhibitors (TKIs). The study aims to assess whether adding asciminib to current TKIs can help achieve a durable deep molecular response and prolong remission. This phase 2 trial is sponsored by the Korean Society of Hematology and addresses the challenge of regaining remission in patients who previously lost it after stopping TKIs. Participants will receive asciminib combined with their ongoing TKI treatment. The plan includes restarting TKIs if participants lose a certain level of molecular response (MR3.0) after stopping treatment, which is considered a reasonable approach. The treatment period involves maintaining a very deep molecular response (MR4.5) for more than three years while using asciminib alongside TKIs, with the possibility of stopping treatment after sustained remission. During the study, participants will be closely monitored through molecular response testing to evaluate remission levels. The primary outcome is the maintenance of MR3.0 or better at one year. Researchers will also assess organ function and safety throughout the study. Participants are expected to sign informed consent and undergo regular assessments to ensure eligibility and track treatment effects. The total duration and follow-up details are aligned with achieving long-term treatment-free remission.
CONDITIONS
Brief Title
A Study of Treatment-free Remission in Chronic Phase Chronic Myeloid Leukemia
Who Can Participate
Age: 19Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 19 years of age or older
- Diagnosed with chronic phase chronic myeloid leukemia (CP-CML)
- Currently taking tyrosine kinase inhibitors (imatinib, nilotinib, or dasatinib) for 5 years or more
- Failed to maintain MR3.0 after one or more attempts to stop TKI treatment
- Regained MR3.0 or deeper molecular response after restarting TKIs following cessation failure
- Taking TKIs for at least 12 weeks after TKI cessation failure
- Agree to stop asciminib and TKIs after maintaining MR4.5 for 2 or more years
- Have adequate organ function as defined by specific bilirubin, creatinine clearance, and serum lipase levels
- Able to give informed consent voluntarily
You will not qualify if you...
- Experienced grade 3 or higher adverse events with TKIs (imatinib, dasatinib, nilotinib)
- Receiving any other investigational treatments
- Have uncontrolled infections
- Previously received CAR-T cell therapy, allogeneic stem cell transplant, or biologic therapy
- Have clinically significant cardiovascular disease or gastrointestinal dysfunction
- History of thromboembolic episodes within 3 months before enrollment
- Active hepatitis B or C with uncontrolled disease
- Have active cancers requiring treatment other than CML
- Severe or uncontrolled medical conditions affecting participation
- Psychiatric illness or social situations limiting study compliance
- Pregnant or breastfeeding women due to potential risks to infants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Until participants maintain MR4.5 for 2 or more years or fail to sustain MR3.0 after cessation
Participants receive asciminib in combination with tyrosine kinase inhibitors to achieve sustainable molecular response and prolong treatment-free remission.
Regular visits during treatment as per protocol
Trial Site Locations
Total: 1 location
1
Gachon University Gil Medical Center
Incheon, Incheon, South Korea, 21565
Actively Recruiting
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Research Team
H
Hawk Kim
E
Eunju Park
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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