[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cmlblast-phase\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cmlblast-phase":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"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":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100612867","phase-2-modified-conditioning-regimen-for-cml-bp-100612867",false,"NCT07259161","Modified Conditioning Regimen for CML-BP","Prospective, Single-Arm Study on the Efficacy of a Reduced-Toxicity Conditioning Regimen Containing Thiotepa and Melphalan for Patients With Blast Phase Chronic Myeloid Leukemia","Inclusion Criteria:\n\n* (1) Confirmed diagnosis of blast-phase chronic myeloid leukemia, with diagnostic criteria referring to the 2020 Chinese Guidelines for Diagnosis and Treatment of Chronic Myeloid Leukemia.\n\nDiagnostic criteria for chronic myeloid leukemia: Typical clinical manifestations combined with the presence of Philadelphia chromosome and\u002For BCR-ABL fusion gene positivity confirm the diagnosis.\n\nDiagnostic criteria for blast phase:\n\n1. Peripheral blood or bone marrow blasts ≥20%\n2. Aggregates of blasts on bone marrow biopsy\n3. Extramedullary blast cell infiltration (2) Age ≥18 years (3) Ability to provide self-signed informed consent (4) Must meet adequate organ function requirements:\n\nRenal and hepatic function as follows:\n\nAST, ALT and ALP \\\u003C2× upper limit of normal (ULN) Total bilirubin \\\u003C1.5× ULN Creatinine clearance \\>50 mL\u002Fmin\n\nPancreatic function:\n\nSerum amylase ≤1.5× ULN Serum lipase ≤1.5× ULN\n\nNormal cardiac function:\n\nEjection fraction (EF) \\>60% Pulmonary artery systolic pressure ≤50 mmHg (5) HIV negative, HBV negative, HCV negative (6) Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2 (7) Signed informed consent must be obtained before study procedures begin. For subjects aged 18 years or older, informed consent shall be signed by the patient themselves or direct family members. Considering the patient's medical condition, if the patient's own signature is medically inadvisable, the informed consent shall be signed by a legal guardian or the patient's direct family member.\n\nExclusion Criteria:\n\n* 1\\. (1) Patients with previous autologous or allogeneic stem cell transplantation; (2) Patients concurrently diagnosed with other malignant tumors; patients assessed by investigators as having concomitant diseases that severely endanger their life safety or affect their ability to complete this study; (3) Patients with psychiatric disorders or other medical conditions that cannot comply with the requirements of study treatment and monitoring; (4) Patients unable or unwilling to sign the consent form; (5) Pregnant or lactating women; (6) Patients assessed by investigators as ineligible due to other special circumstances.","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Study on the Efficacy and Safety of a Reduced-Toxicity Conditioning Regimen Containing Thiotepa and Melphalan in Patients with Blast Phase Chronic Myeloid Leukemia",[26,27],"CML,Blast Phase","HSCT","NOT_YET_RECRUITING","2025-11-21",{"date":31,"type":32},"2025-12-02","ACTUAL",{"date":34,"type":20},"2025-12-15",{"date":36,"type":20},"2029-09-14",{"name":38,"class":39},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100574328","phase-1-olverembatinib-combined-with-venetoclax-and-azacitidine-in-blast-phase-ph-chromosome-positive-cml-100574328","NCT06757855","Olverembatinib Combined With Venetoclax and Azacitidine in Blast Phase Ph Chromosome-positive CML","A Multicenter, Single-arm I\u002FII Clinical Study of Olverembatinib Combined With Venetoclax and Azacitidine in in Blast Phase Ph Chromosome- Chronic Myeloid Leukemia","Inclusion Criteria:\n\n1. Patients with t(9;22)(q34;q11)\u002FBCR::ABL1 positive blast-phase CML who are aged 15 years or older, whether initially in the blast phase or progressing from the chronic phase, with no gender restriction.\n\n   Blast phase criteria: Conforming to the 2022 WHO criteria for CML Blast phase: bone marrow or peripheral blood blast cells ≥ 20%; for diagnosis of acute lymphoblastic transformation, if the immature lymphoblasts (determined by immunophenotype) ≥ 5% according to the ICC 2022 criteria; blast cell aggregation in bone marrow or extramedullary tissues.\n2. ECOG performance status score ≤ 2.\n3. Major organ function assessment criteria: Total bilirubin \\\u003C 1.5×upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5×ULN; serum creatinine \\\u003C 2×ULN; myocardial enzymes \\\u003C 2×ULN; serum amylase ≤ 1.5×ULN; left ventricular ejection fraction (LEF) within the normal range on echocardiography.\n4. Men and women of reproductive potential agree and adopt effective contraceptive measures.\n5. The informed consent form is signed by the patient himself\u002Fherself or an immediate family member. Considering the patient's condition, if the patient's signature is not conducive to the control of the disease, the legal guardian or an immediate family member of the patient signs the informed consent form.\n\nExclusion Criteria:\n\n1. Before group entry, other systemic anti-cancer treatments for acute transformation were received (excluding single-agent TKI, hormone, or hydroxyurea for reducing tumor burden before group entry, and single-agent olverembatinib ≤ 14 days)\n2. Myocardial infarction occurred within 12 months before enrollment in this study; other clinically significant cardiac diseases (such as unstable angina, congestive heart failure, uncontrollable hypertension, uncontrollable arrhythmia, etc.)\n3. Uncontrolled active severe infection\n4. Known positive serum HIV\n5. Acute pancreatitis occurred within 1 year before study screening, or a history of chronic pancreatitis\n6. Uncontrolled hypertriglyceridemia (triglycerides \\> 450 mg\u002FdL, i.e., 5.1 mmol\u002FL) or hypercholesterolemia (total cholesterol (TC) ≥ 6.2 mmol\u002FL)\n7. Another malignancy diagnosed and treated within 5 years before diagnosis, or previously diagnosed with another malignancy with evidence of residual disease. Patients with non-melanoma skin cancer or any type of carcinoma in situ, if completely resected, should not be excluded\n8. Pregnant or lactating women\n9. Clinical manifestations of CNS leukemia or extramedullary infiltration\n10. Uncontrolled diabetes, defined as glycated hemoglobin value \\> 7.5%. Patients with previously existing but well-controlled diabetes need not be excluded\n11. Mental illness that may prevent the subject from completing treatment or providing informed consent\n12. Other conditions considered unsuitable for this study by the investigator","15 Years",{"count":49,"type":20},29,[51,23],"PHASE1","Even in the TKI era, the outcoms of patients with blast phase is still poor.The response rate to conventional intensive chemotherapy is only 12.5% and the 5-year survival rate is 0 for patients with myeloid blast crsis. The response rate of TKI monotherapy is about 50% and the response rate is further improved when combined TKI and chemotherapy for patients with lymphoid blast crsis. The induction remission rate of chemotherapy alone for patients with Ph-positive acute lymphoblastic leukemia is 50-60%, and the remission rate increases to more than 95% when combined with TKI. Therefore, the application of TKI for patients in the blast crisis phase is of great significance. Olverembatinib is the only third-generation TKI drug approved in the Chinese mainland at present. Preclinical research data show that olverembatinib has a significant inhibitory effect on wild-type and mutant ABL resistant to the first and second-generation TKIs, as well as some complex mutations resistant to ponatinib. Phase I and II clinical studies have shown that for CML patients in the chronic and accelerated phases with resistance or intolerance to various TKIs, with or without T315I mutations, there are significant hematological and molecular responses and survival benefits. Olverembatinib can also inhibit many other kinases related to tumors. In vitro studies have shown that olverembatinib downregulates MCL-1 expression and acts synergistically with BCL-2 inhibitors to induce apoptosis of AML cells.\n\nPreclinical studies have shown that venetoclax has a synergistic effect with TKIs. It upregulates apoptosis-inducing proteins, downregulates anti-apoptotic protein MCL1, inhibits the anti-apoptotic activity of BCL-XL, induces apoptosis of Ph+ cells, overcomes TKI resistance, and eliminates CML leukemia stem cells.\n\nA large amount of evidence indicates that DNA hypermethylation plays an important role in the progression of CML, and abnormal DNA methylation is associated with progression to the accelerated and blast crisis phases and resistance to TKIs.Domestic scholars have reported successful cases of combined treatment with TKI, venetoclax, and demethylating agent azacitidine for CML patients with lymphoid blast crisis.\n\nTherefore, we designed this study to explore the efficacy and safety of olverembatinib, venetoclax, and azacitidine in the treatment of CML patients in the blast crisis phase.",[26],"RECRUITING","2025-05-26",{"date":57,"type":32},"2025-05-30",{"date":59,"type":32},"2025-01-26",{"date":61,"type":20},"2028-12-01",{"name":38,"class":39},1]