[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsedrefractory-acute-myeloid-leukaemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsedrefractory-acute-myeloid-leukaemia":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,69],{"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":25,"conditions":26,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100400967","phase-1-study-of-lisaftoclax-apg-2575-single-agent-and-combination-with-therapy-in-patients-relapsedrefractory-aml-100400967",false,"NCT04501120","Study of Lisaftoclax (APG-2575) Single Agent and Combination With Therapy in Patients Relapsed\u002FRefractory AML","A Phase Ib Study of the Safety, Pharmacokinetic of Lisaftoclax (APG-2575) Single Agent and in Combination With Homoharringtonine or Azacitidine in Patients With Relapsed\u002FRefractory AML","Inclusion Criteria:\n\nSubjects who meet each of the following inclusion criteria are eligible to participate in this study:\n\n1. In accordance with the World Health Organization (WHO) 2016 diagnostic criteria for relapsed or refractory acute myeloid leukemia (AML), Mixed phenotype acute leukemia(MPAL), Chronic myelomonocytic leukemia (CMML), Higher-risk myelodysplastic syndrome (HR-MDS) , Blastic plasmacytoid dendritic cell neoplasm (BPDCN) and naïve AML ineligible for treatment with a standard chemotherapy due to age or comorbidities.\n2. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0 -2 (0 to 3 for participants \\>= 60 to 74 years of age who are evaluated as ineligible for treatment with standard chemotherapy).\n3. Subjects can accept oral administration of Lisaftoclax (APG-2575).\n4. Life expectancy ≥ 3 months.\n5. Adequate renal and liver function.\n6. Males, female patients of childbearing potential (postmenopausal women who must have been menopausal for at least 12 months to be considered infertile) and their partners voluntarily take contraception which the investigator considers effective during treatment and at least three months after the last dose of study drug.\n7. Ability to understand and willingness to sign a written informed consent form (the consent form must be signed by the patient prior to any study-specific procedures).\n8. Willingness and ability to comply with study procedures and follow-up examination.\n\nExclusion Criteria:\n\nPatients who meet any of the following exclusion criteria are not to be enrolled in this study:\n\n1. Patients diagnosed with acute promyelocytic leukemia or t(9;22)(q34.1;q11.2); BCR-ABL1 positive AML patients.\n2. The persistent toxicities caused by previous chemotherapy or radiotherapy has not been restored to lower than grade 2 by CTCAE 5.0 (except for alopecia).\n3. Known leukemia infiltration of the central nervous system.\n4. Symptomatic active fungal, bacterial and\u002For viral infections.\n5. Prior history of allogeneic hematopoietic stem cell transplantation or adoptive cell immunotherapy, autologous hematopoietic stem cell transplantation within 12 months.\n6. Within 14 days before the first dose of study drug, received chemotherapy (hydroxyurea is permitted more than 24 hours before the first dose of study drug), radiotherapy, surgery, immunotherapy, targeted therapy, biological therapy or any investigational treatment.\n7. Within 7 days before the first dose of study drug, received a strong and\u002For moderate CYP3A inducer and\u002For Inhibitor.\n8. At the discretion of the investigator, gastrointestinal diseases that affect the absorption of Lisaftoclax (APG-2575).\n9. Any other condition or circumstance, at the discretion of the investigator, that patients would be unsuitable for participation in the study.","ALL","18 Years",{"count":19,"type":20},682,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The purpose of this study is to assess the safety, pharmacokinetic profile of Lisaftoclax (APG-2575) single agent and in combination with HHT\u002FAZA in patients with relapsed\u002Frefractory AML and related myeloid malignancies.",[27,28],"Relapsed\u002FRefractory Acute Myeloid Leukaemia","Myeloid Malignancy",[30,31,28,32],"Acute Myeloid Leukaemia (AML)","Bcl-2 Inhibitor","Lisaftoclax (APG-2575)","RECRUITING","2026-04-27",{"date":36,"type":37},"2026-04-29","ACTUAL",{"date":39,"type":37},"2020-09-28",{"date":41,"type":20},"2029-09",{"name":43,"class":44},"Ascentage Pharma Group Inc.","INDUSTRY",12,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":68},"100563826","phase-2-mitoxantrone-hydrochloride-liposome-standard-dose-of-cytarabine-and-venetoclax-in-the-treatment-of-rr-aml-100563826","NCT06621212","Mitoxantrone Hydrochloride Liposome, Standard-dose of Cytarabine and Venetoclax in the Treatment of R\u002FR AML","A Prospective, Multi-center, Phase 2 Study of Mitoxantrone Hydrochloride Liposome Injection Combined With Standard-dose Cytarabine and Venetoclax in the Treatment of Relapsed\u002FRefractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n1. Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study.\n2. Age ≥18\n3. Clinically diagnosed relapsed\u002Frefractory AML, excluding acute promyelocytic leukemia.\n\n   1. Patients who failed after at least 1 courses of initial induction therapy.\n   2. Bone marrow blasts≥5% after CR\u002FCRi, or reappearance of blasts in the blood in at least 2 peripheral blood samples at least one week apart, or leukemia cell infiltration appeared in extramedullary.\n   3. Conversion from MRD negativity to MRD positivity after CR\u002FCRi.\n4. Physical status score of Eastern Oncology Collaboration Group (ECOG) 0-2.\n5. Life expectancy \\> 3 months.\n6. AST\u002FALT≤2.5 ULN (for subjects with hepatic infiltration≤5 ULN); Total bilirubin≤1.5 ULN (for subjects with hepatic infiltration≤3 ULN); Serum creatinine≤1.5 ULN.\n\nExclusion Criteria:\n\n1. Previous anti-tumor therapy meets one of the following criteria:\n\n   1. Prior therapy with mitoxantrone or mitoxantrone liposome;\n   2. Prior therapy with doxorubicin or anthracyclines, and the cumulative dose of doxorubicin \\> 360 mg\u002Fm\\^2 (1 mg doxorubicin was equivalent to 2 mg daunorubicin or 0.5 mg idarubicin);\n   3. Have received other anti-tumor therapy (including chemotherapy, targeted therapy, hormone therapy, Chinese medicines with anti-tumor activity, except those that do not affect the efficacy of the study as determined by the investigator) or participated in other clinical trials and received clinical trial drugs within 4 weeks or 5 half-lives of the drug before the study;\n2. Subjects who received strong or moderate CYP3A inducers\u002Finhibitors or P-glycoprotein (P-gp) inhibitors within 7 days before starting study treatment;\n3. Subjects who are unable to take oral medications or have malabsorption syndrome;\n4. Cardiovascular diseases, including but not limited to:\n\n   1. QTc interval \\>480 ms or long QTc syndrome in screening;\n   2. Complete left bundle branch block, 2 or 3 grade atrioventricular block;\n   3. Requiring treatment of serious and uncontrolled arrhythmia;\n   4. New York Heart Association NYHA≥2;\n   5. Cardiac ejection fraction (EF) was less than 50%;\n   6. Myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmia or any other history of arrhythmia or clinically serious pericardial disease that requires treatment within the first 6 months of enrollment, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities.\n5. Central nervous system leukemia;\n6. Previous or current occurrence of other malignancies (in addition to non-melanoma basal cell carcinoma of the skin that is effectively controlled, breast\u002Fcervical carcinoma in situ, and other malignancies that have been effectively controlled without treatment within the past five years).\n7. Subjects are suffering from any other uncontrollable disease (including but not limited to: uncontrolled diabetes and hypertension, and advanced infection);\n8. HIV infection.\n9. HBsAg or HBcAb positive, with HBV-DNA≥1x10\\^3 copies\u002FmL; or HCV-RNA≥1x10\\^3 copies\u002FmL;\n10. A history of immediate or delayed allergy to similar drug and excipients of the investigate drug.\n11. Pregnant, lactating female or subjects who refuse to use effective contraception during the study.\n12. With a history of severe neurological or psychiatric illness.\n13. Not suitable for this study as decided by the investigator.",{"count":54,"type":20},72,[24],"The purpose of this prospective, multi-center, single-arm, phase 2 study is to evaluate the efficacy and safety of a combination regimen of mitoxantrone hydrochloride liposome injection, standard-dose of cytarabine and venetoclax (MAV) in the treatment of relapsed or refractory (R\u002FR) AML. The study plan to enroll 72 R\u002FR AML patients who are expected to receive laboratory tests of bone marrow and blood specimens at regular times after MAV treatment.",[27,28],"2025-09-10",{"date":60,"type":37},"2025-09-16",{"date":62,"type":37},"2024-07-05",{"date":64,"type":20},"2027-12-31",{"name":66,"class":67},"First Affiliated Hospital of Zhejiang University","OTHER",1,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":21,"phases":78,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":68},"100549487","phase-2-mitoxantrone-hydrochloride-liposome-injection-cytarabine-combined-with-venetoclax-in-the-treatment-of-rr-aml-100549487","NCT06434662","Mitoxantrone Hydrochloride Liposome Injection, Cytarabine Combined With Venetoclax in the Treatment of R\u002FR AML","A Phase II Study of the Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Injection, Cytarabine and Venetoclax in Patients With Relapsed\u002FRefractory AML","Inclusion Criteria:\n\n1. Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study.\n2. Age ≥18.\n3. Clinically diagnosed relapsed\u002Frefractory AML, excluding acute promyelocytic leukemia.\n\n   1. Initial treatment patients who failed after 2 courses of treatment with standard regimen.\n   2. Bone marrow blasts≥5% after the first CR\u002FCRi, or reappearance of blasts in the blood in at least 2 peripheral blood samples at least one week apart, or leukemia cell infiltration appeared in extramedullary without treatment.\n   3. First conversion from MRD negativity to MRD positivity without treatment.\n4. Physical status score of Eastern Oncology Collaboration Group (ECOG) : 0-2.\n5. Researchers determined that the patients could tolerate intensive chemotherapy.\n6. Life expectancy \\> 3 months.\n7. AST\u002FALT≤2.5 ULN (for subjects with hepatic infiltration≤5 ULN); Total bilirubin≤1.5 ULN (for subjects with hepatic infiltration≤3 ULN); Serum creatinine≤1.5 ULN.\n\nExclusion Criteria:\n\n1. Previous anti-tumor therapy meets one of the following criteria:\n\n   1. Prior therapy with mitoxantrone or mitoxantrone liposome;\n   2. Prior therapy with doxorubicin or anthracyclines, and the cumulative dose of doxorubicin \\> 360 mg\u002Fm\\^2 (1 mg doxorubicin was equivalent to 2 mg daunorubicin or 0.5 mg idarubicin);\n   3. Have received other anti-tumor therapy (including chemotherapy, targeted therapy, hormone therapy, Chinese medicines with anti-tumor activity, except those that do not affect the efficacy of the study as determined by the investigator) or participated in other clinical trials and received clinical trial drugs within 4 weeks or 5 half-lives of the drug before the study;\n2. Cardiovascular diseases, including but not limited to:\n\n   1. QTc interval \\>480 ms or long QTc syndrome in screening;\n   2. Complete left bundle branch block, 2 or 3 grade atrioventricular block;\n   3. Requiring treatment of serious and uncontrolled arrhythmia;\n   4. New York Heart Association（NYHA≥3;\n   5. Cardiac ejection fraction (EF) was less than 50%;\n   6. Myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmia or any other history of arrhythmia or clinically serious pericardial disease that requires treatment within the first 6 months of enrollment, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities.\n3. Central nervous system leukemia;\n4. Previous or current occurrence of other malignancies (in addition to non-melanoma basal cell carcinoma of the skin that is effectively controlled, breast\u002Fcervical carcinoma in situ, and other malignancies that have been effectively controlled without treatment within the past five years).\n5. Subjects are suffering from any other uncontrollable disease (including but not limited to: uncontrolled diabetes and hypertension, and advanced infection);\n6. HIV infection.\n7. HBsAg or HBcAb positive, with HBV-DNA≥1x10\\^3 copies\u002FmL; or HCV-RNA≥1x10\\^3 copies\u002FmL;\n8. A history of immediate or delayed allergy to similar drug and excipients of the investigate drug.\n9. Pregnant, lactating female or subjects who refuse to use effective contraception during the study.\n10. With a history of severe neurological or psychiatric illness.\n11. Not suitable for this study as decided by the investigator.",{"count":77,"type":20},34,[24],"The goal of this study is to evaluate the efficacy and safety of a combination regimen of mitoxantrone hydrochloride liposome injection, cytarabine and venetoclax (MAV) in the treatment of relapsed or refractory (R\u002FR) AML. It will also tentatively explore the correlation between different biological characteristics and therapeutic efficacy. The main questions it aims to answer are:Dose the combination regimen of MAV enhanced the composite complete remission in R\u002FR AML? Participants will receive laboratory tests of bone marrow and blood specimens at regular times after MAV treatment.",[27,28],"2024-05-23",{"date":83,"type":37},"2024-05-30",{"date":85,"type":37},"2024-02-29",{"date":87,"type":20},"2026-06",{"name":66,"class":67}]