Actively Recruiting
A Study of Treatment-free Remission in Chronic Phase Chronic Myeloid Leukemia
Led by Korean Society of Hematology · Updated on 2026-04-02
69
Participants Needed
1
Research Sites
233 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Study of Treatment-free Remission in Chronic Phase Chronic Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 19 years of age or older
- Diagnosed with chronic phase chronic myeloid leukemia (CP-CML)
- Currently taking TKIs (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 over 12 weeks after restarting treatment
- Agree to stop asciminib and TKIs after maintaining MR4.5 for 23 years
- Adequate organ function including total bilirubin less than 3 times upper limit of normal (ULN), creatinine clearance at least 30 mL/min, and serum lipase less than 1.5 times ULN
- Able to provide informed consent willingly
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 hematopoietic stem cell transplantation, or biologic therapy
- Have significant cardiovascular disease or gastrointestinal dysfunction
- History of thromboembolic episodes within 3 months before enrollment
- Active hepatitis B or C with uncontrolled disease
- Have other active cancers requiring treatment besides CML
- Have severe or uncontrolled medical conditions affecting study participation
- Psychiatric or social issues limiting compliance with study requirements
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Gachon University Gil Medical Center
Incheon, Incheon, South Korea, 21565
Actively Recruiting
Research Team
H
Hawk Kim
CONTACT
E
Eunju Park
CONTACT
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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