[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-phase-chronic-myelogenous-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-phase-chronic-myelogenous-leukemia":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,39,65],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100533749","impact-of-personality-on-adherence-to-tyrosine-kinase-inhibitor-therapy-in-pts-wchronic-myeloid-leukemia-100533749",false,"NCT06229860","Impact of Personality on Adherence to Tyrosine Kinase Inhibitor Therapy in Pts w\u002FChronic Myeloid Leukemia","Impact of Personality on Adherence to Tyrosine Kinase Inhibitor Therapy in Patients With Chronic Myeloid Leukemia","Inclusion Criteria:\n\n* 18 years of age or older\n* Diagnosed with chronic myeloid leukemia (CML) and in the chronic phase (CML-CP)\n* Currently being treated with one of four cancer medications - imatinib, dasatinib, bosutinib, or nilotinib\n* A patient at the UCI Chao Family Comprehensive Cancer Center (CFCCC), or\n* A member of a patient support group organized by the CML Buster Foundation\n* Do not meet any of the criteria listed under \"Exclusion Requirements\"\n\nExclusion Criteria:\n\n* Unable to read and speak English\n* Impaired decisional capacity to consent","ALL","18 Years",{"count":19,"type":20},75,"ESTIMATED","OBSERVATIONAL","This is an observational pilot study to examine the association between a patient's personality and adherence to tyrosine kinase inhibitor therapy in patients with chronic myeloid leukemia.",[24,25],"Chronic Myeloid Leukemia","Chronic Phase Chronic Myelogenous Leukemia","RECRUITING","2026-03-06",{"date":29,"type":30},"2026-03-10","ACTUAL",{"date":32,"type":30},"2024-01-25",{"date":34,"type":20},"2026-12",{"name":36,"class":37},"University of California, Irvine","OTHER",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":38},"100439867","phase-2-astx727-and-dasatinib-for-the-treatment-of-newly-diagnosed-philadelphia-chromosome-or-bcr-abl-positive-chronic-myeloid-leukemia-in-chronic-phase-100439867","NCT05007873","ASTX727 and Dasatinib for the Treatment of Newly Diagnosed Philadelphia Chromosome or BCR-ABL Positive Chronic Myeloid Leukemia in Chronic Phase","Phase II Study Assessing Safety and Clinical Activity of the Combination of ASTX727 With Dasatinib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase (CML-CP)","Inclusion Criteria:\n\n* Diagnosis of Philadelphia chromosome (Ph)-positive or BCR-ABL positive CML in early chronic phase CML (i.e., time from diagnosis ≤12 months). Except for hydroxyurea and\u002For 1 to 2 doses of cytarabine patients must have received no or minimal prior therapy, defined as \\\u003C 1 month (30 days) of prior Food and Drug Administration (FDA) approved tyrosine kinase inhibitor (TKI)\n\n  * Clonal evolution defined as the presence of additional chromosomal abnormalities other than the Ph chromosome has historically been included as a criterion for accelerated phase. However, patients with clonal evolution as the only criterion of accelerated phase have a significantly better prognosis, and when present at diagnosis may not impact the prognosis at all. Thus, patients with clonal evolution at diagnosis (early disease) and no other criteria for accelerated phase will be eligible for this study.\n* Eastern Cooperative Oncology Group (ECOG) performance of 0-2\n* Adequate end organ function, defined as the following: total bilirubin \\\u003C1.5x ULN (unless secondary to Gilbert's disease, in which case should be \\\u003C 2.5x ULN), SGPT \\\u003C3x ULN, creatinine clearance ≥ 30mL\u002Fmin calculated using modified Crokcroft-Gault.\n* Patients must sign an informed consent indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital.\n* Males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until 3 months after the last treatment.\n\nExclusion Criteria:\n\n* New York Heart Association (NYHA) cardiac class 3-4 heart disease\n* Cardiac Symptoms: Patients meeting the following criteria are not eligible unless cleared by Cardiology:\n\n  * Uncontrolled angina within 3 months\n  * Diagnosed or suspected congenital long QT syndrome\n  * Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes).\n  * Prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (\\> 460 msec)\n  * History of significant bleeding disorder unrelated to cancer, including unless cleared by hematologist or hemato-oncologist\n\n    * Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)\n    * Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)\n* Patients with active, uncontrolled psychiatric disorders include: psychosis, major depression, and bipolar disorders\n* Subject is known to be positive for human immunodeficiency virus (HIV) (HIV testing is not required)\n* Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:\n\n  * Uncontrolled and\u002For active systemic infection (viral, bacterial or fungal)\n  * Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface \\[HBs\\] antigen negative-, anti-HBs antibody positive and anti-hepatitis B core \\[HBc\\] antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate\n* Women of pregnancy potential must practice an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized. Prior to study enrollment, women of childbearing potential (WOCBP) must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Women must continue birth control for the duration of the trial and at least 3 months after the last dose of study drug.\n\nPregnant or breast-feeding women are excluded.\n\nAll WOCBP must have a negative pregnancy test prior to first receiving investigational product. If the pregnancy test is positive, the patient must not receive study drug and must not be enrolled in the study\n\n* Patients in late chronic phase (i.e., time from diagnosis to treatment \\> 12 months), accelerated (except as noted in inclusion criteria 4.1) or blast phase are excluded. The definitions of CML phases are as follows:\n\n  * Early chronic phase: time from diagnosis to therapy ≤ 12 months\n  * Late chronic phase: time from diagnosis to therapy \\> 12 months\n  * Blastic phase: presence of 30% blasts or more in the peripheral blood or bone marrow\n  * Accelerated phase CML: presence of any of the following features:\n\n    * Peripheral or marrow blasts 15% or more\n    * Peripheral or marrow basophils 20% or more\n    * Thrombocytopenia \\\u003C 100 x 10\\^9\u002FL unrelated to therapy\n    * Documented extramedullary blastic disease outside liver or spleen",{"count":47,"type":20},70,"INTERVENTIONAL",[50],"PHASE2","This phase II trial studies the effect of ASTX727 and dasatinib in treating patients with newly diagnosed Philadelphia chromosome or BCR-ABL positive chronic myeloid leukemia in chronic phase. Philadelphia chromosome positive and BCR-ABL positive are types of genetic mutations (changes). Chemotherapy drugs, such as ASTX727, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. ASTX727 and dasatinib may help to control Philadelphia chromosome-positive chronic myeloid leukemia or BCR-ABL positive chronic myeloid leukemia in chronic phase.",[25,53,54,55],"Philadelphia Chromosome Positive","BCR-ABL1 Positive Chronic Myelogenous Leukemia","BCR-ABL1 Positive","2026-02-17",{"date":58,"type":30},"2026-02-18",{"date":60,"type":30},"2021-10-21",{"date":62,"type":20},"2026-10-30",{"name":64,"class":37},"M.D. Anderson Cancer Center",{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":48,"phases":73,"briefSummary":74,"conditions":75,"keywords":76,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":91},"100426825","phase-2-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-100426825","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","Eligibility for Consolidation Treatment Phase\n\nInclusion Criteria:\n\n1. Age ≥18 years old.\n2. Willing and able to give informed consent.\n3. Diagnosed with chronic myelogenous leukemia (CML) in chronic phase without BCR::ABL1 \\^T315I and have either the b3a2 (e14a2) or b2a2 (e13a2) variants that give rise to the p210 BCR::ABL1 protein. Subtype classification whether b3a2 (e14a2) or b2a2 (e13a2) is not required for study eligibility.\n4. Must have a documented history of attempting only one prior TKI discontinuation under the guidance of a treating physician. TKI includes dasatinib, imatinib or nilotinib.\n5. Must have met all the following criteria prior to first attempt to discontinue their TKI:\n\n   * Stable molecular response (MR4; \\\u003C 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 \\\u003C 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.\n   * 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.\n   * Has been on any number of TKIs, but has not been resistant to any TKI (changes made for intolerance are allowed).\n6. Must have relapsed (defined as loss of major molecular response (MMR), RQ-PCR for BCR::ABL1 \\>0.1% IS after first attempted TKI discontinuation.\n7. 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.\n8. 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).\n9. Eastern Cooperative Oncology Group (ECOG) performance status 0-3.\n10. Must have a RQ-PCR for BCR::ABL1 \\\u003C 0.0032% IS (MR4.5) reported by the trial designated central lab at the time of study enrollment.\n11. 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.\n12. eGFR ≥ 30 mL\u002Fmin as calculated using the 2021 chronic kidney disease epidemiology (CKD-EPI) creatinine equation (https:\u002F\u002Fwww.kidney.org\u002Fprofessionals\u002Fkdoqi\u002Fgfr\\_calculator)\n13. Female patients must meet one of the following:\n\n    * Postmenopausal for at least one year before the screening visit,\n    * Surgically sterile\n    * 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,\n    * Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable\n    * 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.)\n14. Male patients, even if surgically sterilized (i.e., status post vasectomy), must agree to one of the following:\n\n    * Practice effective barrier contraception during the entire study treatment period and through 90 days after the last study drug dose.\n    * Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable.\n    * 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.)\n\nExclusion Criteria:\n\n1. History of accelerated or blast phase CML.\n2. A second malignancy requiring active treatment.\n3. History of recent (within 12 months) acute pancreatitis or chronic pancreatitis.\n4. Subjects who have previously received treatment with asciminib.\n5. Subjects with platelet (PLT) count \\\u003C 100 × 109\u002FL or an absolute neutrophil count (ANC) of \\\u003C 1 × 109\u002FL or hemoglobin \\\u003C 8 g\u002FdL.\n6. Aspartate aminotransferase (AST) and alanine transaminase (ALT) ≥3 times the institutional upper limit of normal.\n7. Total bilirubin ≥ 1.5 times the institutional upper limit of normal (unless direct bilirubin is within normal limits).\n8. Pregnant or lactating.\n9. Unable to comply with lab appointment schedule and patient-reported outcome (PRO) assessments.\n10. Another investigational drug within four weeks of enrollment.\n11. Any serious medical or psychiatric illness that could, in the investigator's opinion, interfere with the completion of treatment according to this protocol.\n12. Patient has undergone a prior allogeneic stem cell transplant.\n13. Screening 12-lead electrocardiogram (ECG) showing a baseline corrected QT interval \\>480msec (patients with a pacemaker will still be eligible with QTc\\>500msec).\n14. Known active hepatitis B infection.\n\nEligibility for TFR Phase:\n\n1. Stable molecular response (MR4.5; \\\u003C 0.0032% IS) documented on at least three tests (may include TFR phase screening PCR) by the trial designated lab, performed approximately three months apart while on consolidation phase.\n2. TFR phase screening PCR RQ-PCR for BCR::ABL1 \\\u003C 0.0032% IS (MR4.5) by the trial designated lab.\n3. ECOG 0-3.\n4. Completion of 12 cycles on the consolidation therapy phase.",{"count":72,"type":20},51,[50],"This is a single arm phase II study that will enroll a minimum of 47 subjects with a maximum of 51. All patients will have a confirmed diagnosis of chronic phase chronic myeloid Leukemia and must have previously attempted to discontinue Tyrosine Kinase inhibitors (TKI). All patients must have restarted the same TKI they were on prior to discontinuation at the time of relapse in order to be eligible for this trial.",[25],[77,78,79,80,81],"chronic myelogenous leukemia","treatment-free remission","tyrosine kinase inhibitors","H. Jean Khoury Cure CML Consortium","Asciminib","2025-07-27",{"date":84,"type":30},"2025-07-30",{"date":86,"type":30},"2021-11-11",{"date":88,"type":20},"2029-07",{"name":90,"class":37},"Medical College of Wisconsin",4]