[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cml-chronic-phase\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cml-chronic-phase":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,47,74,98,129,154],{"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":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100547589","phase-2-pearl-study-potential-of-asciminib-in-the-early-treatment-of-cml-100547589",false,"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","ALL","18 Years",{"count":20,"type":21},160,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","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.",[27,28,29,30],"CML, Chronic Phase","Chronic Myeloid Leukemia, Chronic Phase","Chronic Myeloid Leukemia, BCR\u002FABL-Positive","Chronic Myeloid Leukemia",[32,33],"asciminib","nilotinib","RECRUITING","2025-07-07",{"date":37,"type":38},"2025-07-08","ACTUAL",{"date":40,"type":38},"2025-06-26",{"date":42,"type":21},"2032-06",{"name":44,"class":45},"Gruppo Italiano Malattie EMatologiche dell'Adulto","OTHER",11,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100548662","phase-3-study-of-olverembatinib-hqp1351-in-patients-with-cp-cml-100548662","NCT06423911","Study of Olverembatinib (HQP1351) in Patients With CP-CML","This is a Global, Multi-center, Open-label Randomized and Registrational Phase 3 Study of Olverembatinib (HQP1351) in Patients With Chronic Phase Chronic Myeloid Leukemia","POLARIS-2","Inclusion Criteria:\n\nPatients eligible for inclusion in this study must meet all of the following criteria.\n\n1. Age ≥ 18 years old.\n2. Diagnosis of CML-CP\n3. Part A: Previously treated with at least two approved TKIs Part B: T315I mutation at screening.\n4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2.\n5. Written informed consent obtained prior to any screening procedures.\n6. Patients with adequate organ functions\n\nExclusion Criteria:\n\nPatients eligible for this study must not meet any of the following criteria.\n\n1. For Part A only: T315I mutation at any time prior to starting study treatment.\n2. Active infection that requires systemic drug therapy\n3. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter absorption of study drugs\n4. Previous treatment with or known \u002F suspected hypersensitivity to olverembatinib or any of its excipients.\n5. Previous treatment with or known \u002F suspected hypersensitivity to bosutinib or any of its excipients.\n6. Pregnant or nursing (lactating) women.","99 Years",{"count":57,"type":21},285,[59],"PHASE3","A Global Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients with Chronic Phase Chronic Myeloid Leukemia (POLARIS-2)",[30,62,27],"CML","2025-05-29",{"date":65,"type":38},"2025-06-03",{"date":67,"type":38},"2024-02-05",{"date":69,"type":21},"2026-02",{"name":71,"class":72},"Ascentage Pharma Group Inc.","INDUSTRY",1,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":97},"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":82,"type":21},173,[59],"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.",[28,27,86,87],"CML, Refractory","CML - Philadelphia Chromosome","2024-10-24",{"date":90,"type":38},"2024-10-28",{"date":92,"type":38},"2018-06-25",{"date":94,"type":21},"2027-12-31",{"name":96,"class":72},"Il-Yang Pharm. Co., Ltd.",18,{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":105,"enrollmentInfo":106,"targetDuration":4,"studyType":22,"phases":108,"briefSummary":110,"conditions":111,"keywords":115,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":125,"leadSponsor":127,"locationsCount":4},"100556876","phase-1-study-of-hs-10382-combination-in-patients-with-chronic-myeloid-leukemia-cml-100556876","NCT06530810","Study of HS-10382 Combination in Patients With Chronic Myeloid Leukemia (CML)","A Phase 1b, Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10382 Combination Therapy in Patients With Chronic Myeloid Leukemia","Inclusion Criteria:\n\n* Signed informed consent form.\n* Men or women aged more than or equal to (≥) 18 years, and less than (\\\u003C) 75 years.\n* CML-CP\u002FAP patients with the Ph chromosome or BCR-ABL1 fusion genes.\n* Patient with CML-CP\u002FAP who are resistant to or intolerant to previous TKIs therapy.\n* ECOG performance status of 0-1 and no worsening within 2 weeks before the first dose.\n* Life expectancy ≥ 12 weeks.\n* Men or women should be using adequate contraceptive measures throughout the study; Females should not be breastfeeding at the time of screening, during the study and until 6 months after completion of the study.\n* Females must have evidence of non-childbearing potential.\n\nExclusion Criteria:\n\n* CML-CP patients who have acquired CCyR and have not lost it.\n* Patients with CML-CP who have progressed to AP or blast phase(BP.)\n* Patients with CML-AP who have obtained CHR or no evidence of CML in peripheral blood.\n* Patients with CML-AP who have progressed to BP.\n* Previous treatment with a BCR-ABL1 TKI allosteric inhibitor .\n* Impaired cardiac function including any one of the following:\n* Resting corrected QT interval (QTc) \\> 470 ms obtained from electrocardiogram (ECG), using the screening clinic's ECG machine and Fridericia's formula for QT interval correction (QTcF).\n* Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG.\n* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events,\n* Left ventricular ejection fraction (LVEF) ≤ 50%.\n* Myocardial infarction occurred within 6 months of the first scheduled dose of study drug.;\n* Congestive heart failure occurred within 6 months of the first scheduled dose of study drug.;\n* Uncontrollable angina.\n* History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis\n* Any severe or uncontrolled systemic diseases (i.e. uncontrolled hypertension or diabetes).\n* Clinically severe gastrointestinal dysfunction that may affect drug intake, transport or absorption.\n* Severe infection within 4 weeks prior to the first scheduled dose of study drug\n* Inadequate other organ function.\n* History of other malignancies.\n* History of hypersensitivity to any active or inactive ingredient of HS-10382 and flumatinib.\n* History of neuropathy or mental disorders, including epilepsy and dementia.\n* Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements","75 Years",{"count":107,"type":21},100,[109],"PHASE1","HS-10382 is a small molecular, oral potent, allosteric inhibitor. By binding a myristoyl site of the BCR-ABL1 protein, HS-10382 locks BCR-ABL1 into an inactive conformation. Flumatinib is the first approved second generation TKI in China and a derivative of imatinib.\n\nThe primary objective of this study is to evaluation the safety and tolerability and of HS-10382 combination therapy in patients with chronic myeloid leukemia (CML).\n\nThe secondary objectives is to evaluate the PK profile, major metabolites and efficacy of HS-10382 in CML-CP\u002FAP subjects after combination therapy, and to explore the kinase domain mutations associated with TKI resistance",[112,113,114],"Chronic Myelogenous Leukemia","CML Chronic Phase","CML Accelerated Phase",[116,117,118,119],"CML-CP\u002FAP","HS-10382","Flumatinib","Allosteric inhibitor","NOT_YET_RECRUITING","2024-07-26",{"date":123,"type":38},"2024-07-31",{"date":123,"type":21},{"date":126,"type":21},"2028-05-08",{"name":128,"class":72},"Jiangsu Hansoh Pharmaceutical Co., Ltd.",{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":136,"enrollmentInfo":137,"targetDuration":4,"studyType":22,"phases":139,"briefSummary":140,"conditions":141,"keywords":143,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":73},"100467510","phase-1-a-study-of-hs-10382-in-patients-with-chronic-myeloid-leukemia-100467510","NCT05367700","A Study of HS-10382 in Patients With Chronic Myeloid Leukemia.","A Phase I, Open-label, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of Single and Multiple Doses of Oral Administration of HS-10382 in Patients With Chronic Myeloid Leukemia.","Inclusion Criteria:\n\n1. Signed informed consent form.\n2. Men or women aged more than or equal to (≥) 18 years, and less than (\\\u003C) 75 years.\n3. CML-CP\u002FAP patients with the Ph chromosome or BCR-ABL1 fusion genes.\n4. Patient with CML-CP\u002FAP who are resistant to or intolerant to previous TKIs therapy.\n5. ECOG performance status of 0-2.\n6. Life expectancy ≥ 12 weeks.\n7. Men or women should be using adequate contraceptive measures throughout the study; Females should not be breastfeeding at the time of screening, during the study and until 6 months after completion of the study.\n8. Females must have evidence of non-childbearing potential.\n\nExclusion Criteria:\n\n1. CML-CP patients who have acquired CCyR and have not lost it.\n2. Patients with CML-CP who have progressed to AP or blast phase(BP.)\n3. Patients with CML-AP who have obtained CHR or no evidence of CML in peripheral blood.\n4. Patients with CML-AP who have progressed to BP.\n5. Previous treatment with a BCR-ABL1 TKI allosteric inhibitor .\n6. Impaired cardiac function including any one of the following:\n\n   1. Resting corrected QT interval (QTc) \\> 470 ms obtained from electrocardiogram (ECG), using the screening clinic's ECG machine and Fridericia's formula for QT interval correction (QTcF).\n   2. Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG.\n   3. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events,\n   4. Left ventricular ejection fraction (LVEF) ≤ 50%.\n   5. During screening period, ECG examination showed average heart rate \\\u003C50 beats per minute.\n   6. Myocardial infarction occurred within 6 months of the first scheduled dose of HS-10382.;\n   7. Congestive heart failure occurred within 6 months of the first scheduled dose of HS-10382.;\n   8. Uncontrollable angina.\n7. History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis\n8. Any severe or uncontrolled systemic diseases (i.e. uncontrolled hypertension or diabetes).\n9. Clinically severe gastrointestinal dysfunction that may affect drug intake, transport or absorption.\n10. Severe infection within 4 weeks prior to the first scheduled dose of HS-10382.\n11. History of significant congenital or acquired bleeding disorders unrelated to CML.\n12. Inadequate other organ function.\n13. History of other malignancies.\n14. History of hypersensitivity to any active or inactive ingredient of HS-10382.\n15. History of neuropathy or mental disorders, including epilepsy and dementia.\n16. Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.","74 Years",{"count":138,"type":21},108,[109],"HS-10382 is a small molecular, oral potent, allosteric inhibitor. By binding a myristoyl site of the BCR-ABL1 protein, HS-10382 locks BCR-ABL1 into an inactive conformation. The purpose of this study is to investigate the safety\u002Ftolerability and the pharmacokinetic(PK) profile of HS-10382 in patients with chronic myeloid leukemia (CML). Anti-CML activity will also be investigated in this study.",[27,142],"CML, Accelerated Phase",[116,117,144,145,119],"BCR-ABL TKI","Phase I","2023-01-12",{"date":148,"type":38},"2023-01-13",{"date":150,"type":38},"2022-04-28",{"date":152,"type":21},"2026-09-30",{"name":128,"class":72},{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":22,"phases":163,"briefSummary":165,"conditions":166,"keywords":167,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":73},"100467515","phase-4-a-real-world-study-of-the-efficacy-and-safety-of-flumatinib-versus-imatinib-in-patients-with-newly-diagnosed-chronic-myeloid-leukemia-in-chronic-phase-100467515","NCT05367765","A Real World Study of the Efficacy and Safety of Flumatinib Versus Imatinib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase","Evaluating the Efficacy and Safety of Flumatinib Versus Imatinib for in Patients With Newly Diagnosed Chronic Myeloid Leukemia (CML)-in Chronic Phase (CP): A Multicenter, Open-label, Real World Study","Inclusion Criteria:\n\n1. Men or women aged more than or equal to (≥) 18 years.\n2. Patients with Philadelphia chromosome positive chronic myelogenous leukemia in chronic phase (Ph+ CML-CP) within 6 months of diagnosis..\n3. Eastern Cooperative Oncology Group (ECOG) performance status: 0\\~2.\n4. Signed and dated Informed Consent Form.\n\nExclusion Criteria:\n\n1. Patients with previously documented T315I mutation.\n2. Received BCR-ABL TKI(s) treatment before enrollment.\n3. Any treatment with anti-CML therapy over 2 weeks or hematopoietic stem cell transplantation before enrollment\n4. Participated in other clinical trials that might affect the efficacy and safety of CML during this study.\n5. Pregnant or lactating female.",{"count":162,"type":21},2400,[164],"PHASE4","Flumatinib is an orally available TKI with high selectivity and potency against BCR-ABL1 kinase. It's a multi-center, open-label, real world study to explore the efficacy and safety of Flumatinib versus Imatinib as the first line therapy in patients with chronic myleiod leukemia(CML) in chronic phase(CP).",[27],[30,118,144,168,169],"Real World","Prospective","2022-05-05",{"date":172,"type":38},"2022-05-10",{"date":174,"type":21},"2022-04-30",{"date":176,"type":21},"2028-04-30",{"name":128,"class":72}]