[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-myeloid-leukemia-in-chronic-phase\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-myeloid-leukemia-in-chronic-phase":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,77],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100657540","phase-4-de-escalation-strategy-of-tyrosine-kinase-inhibitors-before-treatment-discontinuation-in-patients-with-chronic-myeloid-leukemia-100657540",false,"NCT07839988","De-escalation Strategy of Tyrosine Kinase Inhibitors Before Treatment Discontinuation in Patients With Chronic Myeloid Leukemia","De-escalation Strategy of Tyrosine Kinase Inhibitors Before Treatment Discontinuation in Patients With Chronic Myeloid Leukemia: Dose Reduction Versus Discontinuation - a Multicenter, Prospective, Randomized Controlled Study","DESCML","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Patients in chronic phase, with no history of accelerated phase (AP-CML) or blast phase (BP-CML).\n3. Treatment with a first-generation TKI for ≥5 years; treatment with a second-generation TKI for ≥3 years; for resistant patients, treatment with an effective TKI for ≥5 years.\n4. Prior evidence of detectable BCR::ABL1 transcripts. Stable deep molecular response (DMR) for \\>2 years (MR⁴, BCR::ABL1¹⁵ ≤0.01%), with at least 4 test results meeting the criterion and each test at least 3 months apart.\n5. Availability of reliable qPCR testing with a sensitivity of at least MR⁴·⁵ (BCR::ABL1¹⁵ ≤0.0032%), and test results available within 2 weeks.\n\nExclusion Criteria:\n\n1. Received stem cell transplantation before study entry.\n2. Presence of diseases associated with immunodeficiency, such as syphilis, hepatitis C, or HIV.\n3. Concurrent participation in other clinical studies.\n4. Having another malignant disease, unless the other primary malignancy is currently of no clinical significance or does not require active intervention.\n5. Major surgery within 4 weeks, or not recovered from a previous surgery.\n6. Pregnancy, lactation, or women planning to become pregnant.\n7. Eastern Cooperative Oncology Group performance status (ECOG PS) ≥3.\n8. Inability to comply with protocol procedures or to attend follow-up visits on time.\n9. Known allergy or contraindication to the study drug (active pharmaceutical ingredient and\u002For excipients).\n10. Any other condition that the investigator considers makes the patient unsuitable for enrolment.","ALL","18 Years","80 Years",{"count":21,"type":22},280,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","The goal of this clinical trial is to learn if a 1-year dose-reduction strategy with tyrosine kinase inhibitors (TKIs) - before complete discontinuation - works to improve treatment-free remission in adults with chronic-phase chronic myeloid leukaemia (CML) who have already achieved stable deep molecular response and are eligible to stop therapy. It will also learn about the safety of this gradual reduction approach.\n\nThe main questions it aims to answer are:\n\nDoes the dose-reduction strategy lead to a higher 2-year molecular relapse-free survival rate (maintaining major molecular response, BCR-ABL1 ≤0.1%) compared with immediate TKI discontinuation? What medical problems (adverse events) do participants experience during and after dose reduction, and how do they differ from those in the direct-stop group? Researchers will compare the dose-reduction group (reduced daily TKI for 12 months, then 1-year follow-up) with the direct-discontinuation group (immediate stop, 2-year follow-up) to see whether gradual reduction is superior in preserving molecular remission. In addition, they will compare the changes in T-cell subsets between the two groups to explore immune mechanisms that may influence treatment-free remission.\n\nParticipants will:\n\nBe randomly assigned to either dose reduction or immediate discontinuation; Take reduced TKI (or no drug) daily for 1 year, followed by 1-year observation (total 24 months); Visit the clinic every 2 months for the first 6 months, then every 3 months thereafter, for physical exams, blood tests, molecular monitoring (BCR-ABL1 PCR), and ECG; Have T-cell subsets measured by flow cytometry at months 3, 6, 12, and 24; Complete quality-of-life questionnaires (EORTC QLQ-CML24) at baseline and at months 3, 6, 12, and 24; Report all adverse events; if MMR is lost, they must restart full-dose TKI and be monitored monthly until remission is regained;",[28],"Chronic Myeloid Leukemia in Chronic Phase",[30,31,32,33,34,35],"CML","Tyrosine kinase inhibitors","TFR","De-escalation","Discontinuation","MMR","NOT_YET_RECRUITING","2026-09-20",{"date":39,"type":40},"2026-09-24","ACTUAL",{"date":42,"type":22},"2026-09-09",{"date":44,"type":22},"2030-12-31",{"name":46,"class":47},"Nanfang Hospital, Southern Medical University","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":48},"100621802","real-world-study-of-scemblix-in-the-treatment-of-chronic-myeloid-leukemia-in-china-100621802","NCT07375355","Real-world Study of Scemblix in the Treatment of Chronic Myeloid Leukemia in China","Explore the Effectiveness and Safety of Scemblix (Asciminib) for Newly Diagnosed CML-CP Patients in China Real World Setting (ASC4CN)","ASC4CN","Inclusion Criteria:\n\nPatients eligible for inclusion in this study must meet all the following criteria:\n\n1. 18 years or older at the time of ICF signing;\n2. Newly diagnosed with Ph+ CML-CP within 3 months before enrollment;\n\n   \\- The diagnosis documentation must include the type and quantitative level of the BCR-ABL1 transcript.\n3. Prior treatment with a maximum of 2 weeks of TKIs;\n4. Prior treatment with non-TKI regimens, including interferon and hydroxyurea, is allowed;\n5. Patients scheduled to initiate treatment with asciminib;\n\n   \\- Patients beginning asciminib treatment must receive the first dose within 14 days of signing the ICF;\n6. Signed ICF.\n\nExclusion Criteria:\n\nPatients meeting any of the following criteria are not eligible for inclusion in this study:\n\n1. Previous diagnosis of CML-accelerated phase or blast crisis;\n2. Currently participating in an interventional clinical study for CML;\n3. Having rare, atypical transcript types that cannot be standardised internationally;\n4. Women who are pregnant, lactating or planning to become pregnant during the study;\n5. Concurrent other malignancies (refer to the International ICD-11 diagnosis codes, with diagnostic text including carcinoma, malignant neoplasm, etc.);\n6. Other conditions that are considered not suitable for the study by the investigator.","99 Years",{"count":59,"type":22},200,"OBSERVATIONAL","This is a multicenter, non-interventional real-world study designed to assess the efficacy and safety of asciminib in patients with newly diagnosed CML.The study uses a prospective data collection design to gather baseline, pre- and post-treatment, and long-term follow-up data, enabling a comprehensive assessment of asciminib's clinical benefits.",[28],[64,65],"CML-CP","Asciminib","RECRUITING","2026-03-27",{"date":69,"type":40},"2026-04-01",{"date":71,"type":40},"2026-02-12",{"date":73,"type":22},"2028-12-31",{"name":75,"class":76},"Novartis Pharmaceuticals","INDUSTRY",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":57,"enrollmentInfo":4,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":84,"conditions":85,"keywords":86,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":93,"locationsCount":4},"100390138","managed-access-programs-for-abl001-asciminib-100390138","NCT04360005","Managed Access Programs for ABL001, Asciminib","Inclusion Criteria:\n\n1. An independent request was received from a licensed physician.\n2. The patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment.\n3. The patient is not eligible or able to enrol in a clinical trial or continue participation in such trial.\n4. There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated.\n5. The patient must meet any other medical criteria established by the medical experts responsible for the product or by the health authority in the country of request (as applicable).\n6. Provision of the product will not interfere with the initiation, conduct, or completion of a Novartis clinical trial or overall development program.\n7. Managed Access provision is allowed per local laws\u002Fregulations","EXPANDED_ACCESS","The purpose of this registration form is to list all Managed Access Programs (MAPs) related to ABL001, asciminib",[28],[87,30,64,65,88],"Chronic myeloid leukemia","ABL001","AVAILABLE","2025-12-01",{"date":92,"type":40},"2025-12-05",{"name":75,"class":76}]