[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-myeloid-leukemia-chronic-phase\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-myeloid-leukemia-chronic-phase":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,49,74,107,135,163],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100450311","phase-2-asciminib-as-initial-therapy-for-patients-with-chronic-myeloid-leukemia-in-chronic-phase-100450311",false,"NCT05143840","Asciminib as Initial Therapy for Patients With Chronic Myeloid Leukemia in Chronic Phase","Asciminib as Initial Therapy With Addition of Lower Dose Tyrosine Kinase Inhibitors for Patients With Chronic Myeloid Leukemia Who do Not Achieve Optimal Response or a Deep Molecular Remission (ALERT CML)","ALERTCML","Inclusion Criteria:\n\n1. Age ≥18 years old\n2. Willing and able to give informed consent\n3. Newly diagnosed with CML in chronic phase within 6 months from confirmed diagnosis via bone marrow biopsy\u002Faspirate 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. Minimal prior CML therapy with a TKI for less than or equal to 30 days. Treatment with hydroxyurea, busulfan, anagrelide or other non-specific chemotherapy agents is allowed with no time restrictions within the eligible time from diagnosis.\n5. ECOG performance status 0-2 (appendix 1)\n6. Adequate organ function:\n\n   * AST and ALT \\\u003C 3 times the institutional upper limit of normal (ULN)\n   * 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)\n   * Total bilirubin \\\u003C 1.5 times the institutional ULN or \\\u003C 3.0 x the institutional ULN with Gilbert Syndrome (unless direct bilirubin is within normal limits)\n7. Adequately controlled blood pressure, defined as systolic blood pressure of \\\u003C140 mmHq and diastolic of \\\u003C90 mmHg, at the time of enrollment.\n8. Lipase ≤ 1.5 x ULN. For lipase \\> ULN - ≤ 1.5 x ULN, value should be considered not clinically significant and not associated with risk factors for acute pancreatitis.\n9. Creatine phosphokinase \\\u003C 2.5 x ULN\n10. Female patients must meet one of the following:\n\n    1. Postmenopausal for at least one year before the screening visit,\n    2. Surgically sterile\n    3. 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    4. Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable\n    5. 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.)\n11. Male patients, even if surgically sterilized (i.e., status post vasectomy), must agree to one of the following:\n\n    1. Practice effective barrier contraception during the entire study treatment period and through 90 days after the last study drug dose\n    2. Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable\n    3. 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. Patients with accelerated or blast phase CML (refer to appendix 4)\n2. Active 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 PLT count \\\u003C 50,000 mm3 or ANC of \\\u003C 500 mm3 or Hemoglobin \\\u003C 8 g\u002FdL\n6. Cardiac or cardiac repolarization abnormality, including any of the following:\n\n   1. History within 6 months prior to starting study treatment of myocardial infarction (MI), angina pectoris, coronary artery bypass graft (CABG)\n   2. Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade AV block (e.g., bifascicular block, Mobitz type II and third degree AV block)\n   3. QTcF at screening greater than or equal to 450 msec (male patients), greater than or equal to 460 msec (female patients) unless patient has a pacemaker\n   4. Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:\n\n   i. Risk factors for Torsades de Pointes (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant\u002Fsymptomatic bradycardia ii. Concomitant medication(s) with a \"Known risk of Torsades de Pointes\" per wwwcrediblemeds.org\u002F that cannot be discontinued or replace 7 days prior to starting study drug by safe alternative medication.\n\n   iii. Inability to determine the QTcF interval\n7. Pregnant or lactating\n8. Taking a strong inhibitors or inducers of CYP3A4 or CYP3A4 substrates with narrow therapeutic index (refer to appendix 6) at time of enrollment\n9. Unable to comply with lab appointment schedule and PRO assessments\n10. Another investigational drug within 4 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. Known clinical history of active HBV infection","ALL","18 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study is a multicenter Phase 2, non-randomized, open-label single-group frontline study administering asciminib in patients with newly diagnosed Chronic Myeloid Leukemia-Chronic Phase (CML-CP). The aim of this study is to evaluate the efficacy and safety of asciminib in newly diagnosed CML-CP. Patients will receive asciminib 80 mg orally once daily during the single asciminib phase. Response is determined by PCR (polymerase chain reaction) blood test during the study. Patients who have not achieved a response after 24 months (but no later than 36 months) of single agent asciminib will be offered the addition of a low dose tyrosine kinase inhibitor (low-TKI) namely dasatinib, imatinib, or nilotinib at the investigator's discretion. The following doses of the TKIs will be used:\n\n1. Dasatinib 50 mg daily\n2. Imatinib 300 mg daily\n3. Nilotinib 300 mg daily\n\nPatients will discontinue study treatment if they experience disease progression, or unacceptable toxicity.",[27,28,29,30],"Chronic Myeloid Leukemia, Chronic Phase","Adult CML","Leukemia, Myeloid","Leukemia,Myeloid, Chronic",[32,28,33,34,35],"Chronic Myeloid Leukemia","tyrosine kinase inhibitors","H. Jean Khoury Cure CML Consortium","HJKC3-0004","RECRUITING","2026-06-25",{"date":39,"type":40},"2026-06-29","ACTUAL",{"date":42,"type":40},"2022-04-22",{"date":44,"type":21},"2032-02",{"name":46,"class":47},"University of Alabama at Birmingham","OTHER",8,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100544402","phase-2-a-study-of-treatment-free-remission-in-chronic-phase-chronic-myeloid-leukemia-100544402","NCT06368414","A Study of Treatment-free Remission in Chronic Phase Chronic Myeloid Leukemia","A Study of Treatment-free Remission in Chronic Phase Chronic Myeloid Leukemia in Combination With Asciminib and Tyrosine Kinase Inhibitors","AsterA","Inclusion Criteria:\n\n1. 19 year or older\n2. CP-CML patients who are taking current TKIs (imatinib, nilotinib or dasatinib) for 5 years or more\n3. Patients who have failed maintaining MR3.0 after 1 or more cessation trial of TKIs.\n4. Patients who regained MR3.0 or deeper molecular response by TKIs retrial after TKI cessation failure at the time of screening\n5. Taking TKIs over 12 weeks for the retrial of TKIs after TKI cessation failure\n6. Patients who agree with stopping asciminib and TKIs after maintaining 23 year-duration of MR4.5\n7. Adequate end organ function as defined by:\n\n   * Total bilirubin (TBL) \\\u003C 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\n   * Creatinine clearance (ClCr) ≥ 30 mL\u002Fmin as calculated using Cockcroft-Gault formula\n   * 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\n8. Patients who can sign the informed consent of their own free will\n\nExclusion Criteria:\n\n1. Patients who experienced grade 3 or higher adverse events with TKIs (imatinib, dasatinib, and nilotinib).\n2. Patients who are receiving any other investigational agents.\n3. Patients who currently have uncontrolled infections\n4. Patients who previously received Chimeric antigen receptor T-cell (CAR-T cell) therapy, allogeneic hematopoietic stem cell transplantation (allo-HSCT) or biologic therapy.\n5. Patients with clinically significant cardiovascular disease or gastrointestinal dysfunction.\n6. Patients who have a history of thromboembolic episodes within 3 months prior to the study enrollment.\n7. Patients with active hepatitis B or C with uncontrolled disease activity.\n8. Patients who have active malignancies requiring treatment other than CML.\n9. Patients with any severe and\u002For uncontrolled medical conditions or other conditions that could adversely impact on patients' ability to participate in the study.\n10. Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n11. 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.","19 Years",{"count":59,"type":21},69,[24],"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",[27],"2026-04-01",{"date":65,"type":40},"2026-04-02",{"date":67,"type":40},"2024-03-11",{"date":69,"type":21},"2028-08-31",{"name":71,"class":72},"Korean Society of Hematology","NETWORK",1,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":86,"conditions":87,"keywords":88,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":106},"100528642","phase-1-a-phase-12-clinical-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-efficacy-of-tern-701-in-participants-with-chronic-myeloid-leukemia-cardinal-100528642","NCT06163430","A Phase 1\u002F2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia (CARDINAL)","A Phase 1\u002F2 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants With Chronic Myeloid Leukemia","CARDINAL","Key Inclusion Criteria:\n\n* Male or female participants ≥ 18 years of age at the time of signing the informed consent\n* Have an ECOG performance status score of 0 to 2\n* Have an established cytopathologically confirmed diagnosis of BCR-ABL1 positive CML in Chronic Phase\n* Have received treatment with at least one prior TKI and have treatment failure, suboptimal response, or treatment intolerance\n* Prior treatment with asciminib is allowed\n* Adequate organ function, as assessed by local laboratory\n\nKey Exclusion Criteria:\n\n* Systemic antineoplastic therapy (including prior TKIs, interferon-alfa, therapeutic antibodies, chemotherapy) or other experimental therapy 7 days before the first dose of TERN-701\n* Have completed previous anticancer therapy without resolution of all associated clinically significant toxicity (to ≤ Grade 2 or baseline)",{"count":83,"type":21},180,[85,24],"PHASE1","The goal of the study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of TERN-701, a highly selective allosteric inhibitor of BCR-ABL1, in participants with previously treated chronic phase - chronic myeloid leukemia (CP-CML).\n\nThe study has two parts: Part 1 of the trial (Dose Escalation) will evaluate sequential dose escalation cohorts of TERN-701 administered once daily.\n\nPart 2 (Dose Expansion) consists of randomized, parallel dose expansion cohorts of TERN-701 that will further evaluate the efficacy and safety of 2 recommended dose levels for expansion selected from Part 1. Part 2m (mutation cohort) will further evaluate the efficacy and safety of 500mg of TERN-701 in previously treated CP-CML participants with certain resistance mutations.\n\nIn both Part 1 and Part 2, participants will receive continuous once daily dosing of TERN-701 divided into 28-day cycles. During the treatment period, participants will have scheduled visits to the trial center at Cycle 1 day 1(C1D1), C1D2 (Part 1 only), C1D8, C1D15, and C1D16 (Part 1 only), followed by Day 1 of Cycles 2 through 7, and Day 1 of every 3 cycles thereafter.\n\nApproximately 180 participants could be enrolled in this trial, up to 80 participants in Part 1 (dose escalation), including optional backfill cohorts, approximately 80 participants in Part 2 (randomized dose expansion), and approximately 20 participants in Part 2m (mutation cohort).\n\nAll participants will receive active trial intervention.\n\nFour dose-level cohorts have been evaluated in Part 1; two dose levels will be evaluated in Part 2 (Randomized Dose Expansion), and one dose level will be evaluated in Part 2m (mutation cohort).",[27,32],[89,90,91,92,93,94,80,95],"allosteric inhibitor of BCR-ABL1","CML","TERN-701","chronic myeloid leukemia","T315I","T315I mutant","HS-10382","2026-01-08",{"date":98,"type":40},"2026-01-12",{"date":100,"type":40},"2024-03-26",{"date":102,"type":21},"2030-05-31",{"name":104,"class":105},"Terns, Inc.","INDUSTRY",54,{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":22,"phases":117,"briefSummary":118,"conditions":119,"keywords":122,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":134},"100547589","phase-2-pearl-study-potential-of-asciminib-in-the-early-treatment-of-cml-100547589","NCT06409936","PEARL Study: PotEntial of Asciminib in the eaRly Treatment of CML","Asciminib as Single Agent or in Combination With Nilotinib in the 1st-line Treatment of BCR-ABL1+ Chronic Myeloid Leukemia: a Randomized GIMEMA-GELMC Phase II Study PEARL Study: PotEntial of Asciminib in the eaRly Treatment of CML","PEARL","Inclusion Criteria:\n\n* Cytogenetic and molecular confirmed diagnosis of Ph+ and BCR::ABL1+ CML\n* Age ≥ 18 years\n* Early chronic phase, less than 3 months from diagnosis\n* Evidence at the time of study entry of typical BCR::ABL1 RNA transcripts e13a2 or e14a2 (b2a2 or b3a2), which are required for BCR::ABL1 international scale reporting\n* Prior treatment with any TKI for 30 days or less; prior treatment with hydroxyurea or anagrelide is allowed\n* ECOG performance status of 0, 1 or 2\n* Adequate end organ function as defined by Total bilirubin ≤ 1.5 x ULN except for patients with Gilbert's syndrome who may only be included if total bilirubin ≤ 3.0 x ULN or direct bilirubin ≤ 1.5 x ULN Aspartate transaminase (AST) ≤ 3.0 x ULN Alanine transaminase (ALT) ≤ 3.0 x ULN Serum amylase ≤ ULN Serum lipase ≤ ULN Alkaline phosphatase ≤ 2.5 x ULN, unless considered tumor related Creatinine clearance \\> 50 ml\u002Fmin using Cockcroft-Gault formula\n* Signed written informed consent according to ICH\u002FEU\u002FGCP and national local laws prior to any study procedure\n* An effective form of contraception with their sexual partners from enrolment through 30 days after the end of treatment\n\nExclusion Criteria:\n\n* CML in blast phase (BP) or in second chronic phase after previous BP, according to WHO criteria\n* Previous treatment with TKIs for more than 30 days\n* Refusal or impossibility to give an informed consent\n* History or current diagnosis of cardiac disease indicating significant risk of safety for patients participating in the study such as uncontrolled or significant cardiac disease, including any of the following: recent myocardial infarction (within last 6 months), uncontrolled congestive heart failure, unstable angina (within last 6 months), clinically significant (symptomatic) cardiac arrhythmias (e.g., sustained ventricular tachycardia, and clinically significant second or third degree AV block without a pacemaker).\n* Severe and\u002For uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol (e.g. uncontrolled diabetes, active or uncontrolled infection)\n* History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis\n* History of acute or chronic liver disease\n* History of other active malignancy within 2 years prior to study entry with the exception of previous or concomitant basal cell skin cancer and previous carcinoma in situ treated curatively\n* Known history of Human Immunodeficiency Virus (HIV), Hepatitis B (HBV), or Hepatitis C (HCV) infection. Testing for Hepatitis B surface antigen (HBs Ag) and Hepatitis B core antibody (HBc Ab \u002F anti HBc) will be performed at study entry\n* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection, or gastric bypass surgery)\n* Pregnant or lactating women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.\n* Women of child-bearing potential, unless they are using highly effective methods of contraception during dosing and for 30 days after the end of treatment",{"count":116,"type":21},160,[24],"A phase 2, interventional, randomized unblinded study will be conducted in newly diagnosed CP CML patients, to investigate the efficacy and the safety of asciminib at a dose of 80 mg QD as single agent (arm A) or 40 mg BID in combination with nilotinib 300 mg BID (arm B).\n\nAll patients in both arm A and arm B will be treated for a minimum of 2 years (core phase). If they will have achieved a DMR (MR4), or if it will be in the interest of the patient, the treatment will be continued.\n\nDuring the consolidation phase (2 years) asciminib will be continued at the same dose in both arms; in the combination arm the nilotinib dose will be reduced to 300 mg daily.\n\nThe patients maintaining a stable MR4 up to the end of the fourth year will discontinue the treatment (TFR phase). The rate of TFR at 5 year (1 year after discontinuation) will be evaluated.",[120,27,121,32],"CML, Chronic Phase","Chronic Myeloid Leukemia, BCR\u002FABL-Positive",[123,124],"asciminib","nilotinib","2025-07-07",{"date":127,"type":40},"2025-07-08",{"date":129,"type":40},"2025-06-26",{"date":131,"type":21},"2032-06",{"name":133,"class":47},"Gruppo Italiano Malattie EMatologiche dell'Adulto",11,{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":144,"phases":4,"briefSummary":145,"conditions":146,"keywords":147,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":162},"100525248","ponatinib-in-chronic-myeloid-leukemia-patients-in-chronic-phase-100525248","NCT06119269","Ponatinib in Chronic Myeloid Leukemia Patients in Chronic Phase","Ponatinib in cHronic myelOid LEukemia patieNts In Chronic phaSe: the PHOENICS Protocol","PHOENICS","Patients will be enrolled according the following inclusion criteria:\n\n* Subjects ≥18 years old affected by CML\n* Patients being treated with ponatinib at a dose of 45, 30 or 15 mg\u002Fday for more than 14 days\n* Patients who have provided informed consent to the study\n\nExclusion criteria:\n\n* Subjects \\\u003C18 years old\n* Patients who did not provide an informed consent to the study\n\nThe co-administration of drugs other than ponatinib will not be considered an exclusion criterium, but all of the drugs will be registered (together with daily doses and duration of treatment) as possible factors of ponatinib PK variability.",{"count":20,"type":21},"OBSERVATIONAL","The goal of this retrospective observational study is to evaluate any possible association between plasma concentrations of ponatinib and its pharmacodynamics (efficacy\u002Ftolerability) in patients affected by chronic myeloid leukemia in chronic phase (CML-CP).\n\nIn particular, the aims of the study will be:\n\n* primary aim: to investigate the relationships (if any) between plasma concentrations and activity\u002Ftoxicity of ponatinib in a population of CML-CP patients enrolled in several Italian hematological centers;\n* secondary aim: to set up an algorithm aimed at helping physicians to improve drug dosing based on several variables (i.e., plasma drug concentrations, tolerability, molecular response to therapy).\n\nThe study will enroll CML-CP patients who were exposed to ponatinib as second, third or fourth line of chemotherapy.",[27],[148,149,150,151,152],"Chronic myeloid leukemia, chronic phase","Ponatinib","Therapeutic drug monitoring","Efficacy","Tolerability","2025-06-02",{"date":155,"type":40},"2025-06-05",{"date":157,"type":40},"2023-08-02",{"date":159,"type":21},"2025-12-31",{"name":161,"class":47},"University of Pisa",5,{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":170,"targetDuration":4,"studyType":22,"phases":172,"briefSummary":174,"conditions":175,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":187},"100321030","phase-3-a-phase-3-study-for-the-efficacy-and-safety-of-radotinib-in-cp-cml-patients-with-failure-or-intolerance-to-previous-tkis-100321030","NCT03459534","A Phase 3 Study for the Efficacy and Safety of Radotinib in CP-CML Patients With Failure or Intolerance to Previous TKIs","A Phase 3 Multinational, Multi-center, Single-arm, Open-label Study for the Efficacy and Safety of Radotinib in Ph+ Chronic Phase Chronic Myeloid Leukemia Patients With Failure or Intolerance to Previous TKIs Therapy Including Imatinib","Inclusion Criteria:\n\n1. Male or female patients aged 18 years old\n2. Chronic Phase Ph+ Chronic Myeloid Leukemia patients who failed or intolerance the previous TKIs therapy including Imatinib Imatinib\n3. ECOG scale 0, 1 or 2\n4. Chronic phase is defined as all of the following conditions that subjects meet.\n\n   * Blast in peripheral blood and bone marrow \\\u003C15%\n   * The sum of blast and promyelocyte in peripheral blood and bone marrow \\\u003C30%\n   * Basophil in peripheral blood \\\u003C20%\n   * Platelets count ≥50 × 10\\^9\u002FL (≥ 50,000\u002Fmm3) (But, transient prior therapy related thrombocytopenia \\[\\\u003C 50 × 109\u002FL (\\\u003C 50,000\u002Fmm3)\\] is acceptable\n   * No evidence of involvement of extramedullary leukemia other than enlargements of liver and spleen\n5. Patients who have adequate organ functions as defined below:\n\n   * Total bilirubin \\\u003C 1.5 × upper limit of normal (ULN)\n   * SGOT and SGPT \\\u003C 2.5× ULN\n   * Creatinine \\\u003C 1.5 × ULN\n   * Serum amylase and lipase ≤ 1.5 × ULN\n   * Alkaline Phosphatase ≤ 2.5 × ULN (only if not related to the tumor)\n6. Women of childbearing potential should have a negative serum or urine pregnancy test within 14 days of the enrollment.\n7. Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month (4 weeks) after the last dose of investigational product in such a manner that the risk of pregnancy is minimized.\n\nExclusion Criteria:\n\n1. Patients who have been diagonised accelerated phase and blast crisis CML in previous therapy if only once.\n2. Patients with CCyR at the time of screening\n3. Any below impaired cardiac function:\n\n   * LVEF \\\u003C45% or \\\u003C lower bound of normal limit of study site (whichever higher), confirmed by echocardiogram at the site\n   * Patients who cannot have QT intervals measured according to ECG\n   * Complete left bundle branch block\n   * Patients with cardiac pacemakers\n   * Patients with congenital long QT syndrome or the family history of known long QT syndrome\n   * History of, or presence of symptomatic ventricular or atrial tachyarrhythmias\n   * Clinically significant resting bradycardia (\\\u003C 50 bpm)\n   * The mean QTcF \\>450msec following three consecutive ECG tests at baseline\n\n     : Screening test will be performed again for QTcF after the adjustment of electrolyte if QTcF \\>450msec and the electrolyte is not within the normal range.\n   * Medical history of clinically confirmed myocardial infarction\n   * Medical history of unstable angina (within last 12 months)\n   * Other clinically significant cardiac disease\n4. Patients with T315I point mutations\n5. Patients with central nervous system involvement as cytopathologically confirmed\n6. Severe or uncontrolled chronic disease\n7. Significant medical history of congenital or acquired bleeding disorders that are not related to leukemia\n8. Patients who previously received radiotherapy to at least 25% of the bodies with high portion of bone marrow\n9. Patients who received the major surgery within 4 weeks before the initiation of the IP administration or who failed to recover from the surgery that was performed before then.\n10. Patients who participated in other clinical study and are receiving any other IP.\n11. Patients who cannot give consent to the clinical study.\n12. Patients who have concurrently clinically significant primary malignancy\n13. Patients currently receiving treatment with a strong CYP3A4 inhibitors or strong CYP3A4 inducers or therapeutic Cumarin derivatives and that can neither stop the administration of these drugs before the start of the IP administration nor switch to other drugs.\n14. Patients who are currently receiving treatment with a medication that has the potential to prolong QT intervals and can neither stop the administration of the drugs before the start of the IP administration nor switch to other drugs. If subjects need to start such drug treatments during the study, they should contact the sponsor, IL-YANG PHARM. Co., Ltd.\n15. Gastrointestinal disorder or gastrointestinal disease that may result in a significant change in the absorption of the investigational product\n16. Medical history of acute or chronic pancreatitis within the past one year\n17. Acute or chronic liver, pancreas, or severe kidney disease that are not associated with the disease\n18. Patients known seropositive to human immunodeficiency virus (HIV), current acute or chronic hepatitis B (hepatitis B surface-antigen positive), hepatitis C, or cirrhosis. Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B (HBV DNA \\\u003C 500 IU\u002FmL or site specific local lab normal range lower limit assessed by investigator), and cured hepatitis C patients can be enrolled.\n19. Women patients that meet the following conditions should be excluded from the clinical study.\n\n    * Pregnancy\n    * Breastfeeding\n    * Pregnancy confirmed at screening pregnancy test\n    * Women of childbearing potential who is unwilling to use an appropriate method of contraception during the study\n20. Men patients who are unwilling to use and appropriate method of contraception during the study\n21. Patients who have hypersensitivity to active ingredient or any of the excipients of this investigational product",{"count":171,"type":21},173,[173],"PHASE3","In a multinational, multicenter, single-arm, open-label and Phase III Radotinib clinical study, chronic phase Ph+ chronic myeloid leukemia patients with failure or intolerance to previous TKIs therapy including Imatinib will be recruited. In this phase 3 study, 173 subjects are expected to be enrolled in a single arm with the administration of Radotinib 400mg twice daily, which includes 10% of dropout rate.",[27,120,176,177],"CML, Refractory","CML - Philadelphia Chromosome","2024-10-24",{"date":180,"type":40},"2024-10-28",{"date":182,"type":40},"2018-06-25",{"date":184,"type":21},"2027-12-31",{"name":186,"class":105},"Il-Yang Pharm. Co., Ltd.",18]