[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapserecurrence\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapserecurrence":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,51,75,106,137],{"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":29,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100570945","phase-3-impact-aml-a-randomized-pragmatic-clinical-trial-for-relapsed-or-refractory-acute-myeloid-leukemia-100570945",false,"NCT06713837","IMPACT-AML: A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia.","IMPACT-AML: A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia. IMPACT-AML RPCT","IMPACT-AML","Inclusion Criteria:\n\n* Non-Acute promyelocytic leukemia (APL) AML defined according World Health Organization (WHO) 2022 (or International Consensus Classification (ICC) 2022) criteria\n* 1st or 2nd relapse or refractory according to European leukemia Network (ELN) 2022\n* Patient is clinically candidate to both low intensity therapy and high dose chemotherapy in the opinion of the physician\n* Both low intensity therapy and high dose chemotherapy to which patient is candidate are available and can be provided as per local practice\n* No specific treatment protocol can be rationally considered better suited to patient needs.This specifically include, but is not limited to:\n\n  i) the availability of a drug that is already demonstrated superior to comparator arm and can be considered the only standard of care ii) specific contraindications related to fitness or any medical conditions that deem to avoid one of the two arms of this randomization iii) patient willingness to avoid one of the two arm of this randomization iv) lack of social support that make unfeasible one of the two arm of this randomization\n* Male or Female, aged\\>18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C4\n* A female participant is eligible to participate if she is not pregnant and not breastfeeding. If Women of childbearing potential (WOCBP), negative serum pregnancy test within 14 days of starting treatment must be obtained. WOCBP must adopt highly effective birth control methods, according to guideline \"Recommendation related to contraception and pregnancy testing in clinical trials\". Male patient and his female partner who is of childbearing potential must use 2 methods of birth control (a condom as a barrier method of contraception and one of the highly effective birth control methods, according to guideline \"Recommendation related to contraception and pregnancy testing in clinical trials\". Use of- and compliance to- birth control methods are required beginning at the screening visit and continuing until 6 months following last treatment with study drug.\n* Participant is willing and able to give informed consent for participation in the study\n\nExclusion Criteria:\n\n* Known contraindication to the study drug that will be selected by the treating physician within the list of high or low intensity treatment, according to most update version of Summary of Product Characteristics (SmPC) (e.g. hypersensitivity, allergy, organ failure precluding treatment)\n* Participation in another clinical trial with any investigational agents within 14 days or 5 drug half-lives (whatever comes first) prior to randomization\n* Active infections or other clinical conditions that in the opinion of the investigator make the patient ineligible to receive study treatment.","ALL","18 Years",{"count":20,"type":21},339,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a multicenter, randomized, open-label, pragmatic low intervention clinical trial comparing high intensity reinduction chemotherapy with low intensity therapies in 1st or 2nd relapse Acute Myeloid Leukemia. The study is funded by European Commission (HORIZON-MISS-2022-CANCER-01-03, Project ID 101104421)",[27,28],"Acute Myeloid Leukemia","Relapse\u002FRecurrence",[30,27,31,32,33,34,35,36,37],"Relapsed\u002FRefractory","Low Intensity therapy","Pragmatic","Low intervention Clinical trial","Randomized controlled trial","Horizon Europe","Mission Cancer","Diagnosis and treatment","RECRUITING","2026-06-09",{"date":41,"type":42},"2026-06-10","ACTUAL",{"date":44,"type":42},"2025-02-27",{"date":46,"type":21},"2028-01",{"name":48,"class":49},"Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS","OTHER",47,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100636245","phase-2-bugitinib-combined-with-venetoclax-and-cytarabine-in-relapsedrefractory-acute-myeloid-leukemia-100636245","NCT07563179","Bugitinib Combined With Venetoclax and Cytarabine in Relapsed\u002FRefractory Acute Myeloid Leukemia","A Prospective, Single-Arm Study of Bugitinib Combined With Venetoclax and Cytarabine in Relapsed\u002FRefractory Acute Myeloid Leukemia (Non-M3)","Inclusion Criteria:\n\nParticipants must meet all of the following criteria:\n\n* Age 18-70 years (inclusive), regardless of sex;\n* Diagnosis of non-M3 acute myeloid leukemia (AML), and meeting at least one of the following conditions:\n\n  * Failure to achieve complete remission (CR) after standard induction chemotherapy;\n  * First CR duration ≤12 months;\n  * First CR duration \\>12 months, followed by relapse and failure of at least one line of standard chemotherapy;\n  * Relapsed disease after ≥2 prior lines of therapy;\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;\n* Estimated life expectancy ≥3 months;\n* Adequate organ function, defined as:\n\n  * Cardiac: left ventricular ejection fraction (LVEF) ≥50% by echocardiography, with no clinically significant ECG abnormalities;\n  * Renal: serum creatinine ≤2.0 × upper limit of normal (ULN) and creatinine clearance ≥60 mL\u002Fmin (Cockcroft-Gault);\n  * Hepatic: ALT and AST ≤3.0 × ULN;\n  * Total bilirubin ≤2.0 × ULN (≤3.0 × ULN for patients with Gilbert syndrome);\n  * Oxygen saturation ≥92% on room air;\n* Ability to take oral medications and comply with study procedures;\n* Willingness to participate and provide written informed consent.\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will be excluded:\n\n* Known hypersensitivity to any study drug or its excipients;\n* Active central nervous system (CNS) leukemia (patients with prior CNS involvement who achieved complete remission and are clinically stable may be eligible);\n* Active, uncontrolled bacterial, viral, or systemic fungal infection;\n* Known hereditary bleeding or coagulation disorders, history of non-traumatic bleeding or thromboembolism, or other conditions that may increase bleeding risk;\n* Evidence of active infection, including:\n\n  * Hepatitis B virus (HBV) infection with positive HBsAg or HBcAb and HBV DNA \\>100 copies\u002FmL;\n  * Hepatitis C virus (HCV) antibody positive with detectable HCV RNA;\n  * Human immunodeficiency virus (HIV) infection;\n  * Positive test for syphilis;\n* Active bleeding or clinically significant bleeding tendency, including but not limited to:\n\n  * Active gastrointestinal bleeding, intracranial hemorrhage, or bleeding in other vital organs;\n  * Grade ≥3 bleeding event within 4 weeks prior to enrollment (per CTCAE);\n  * Known hereditary bleeding disorders (e.g., hemophilia);\n  * Severe platelet dysfunction not correctable;\n* Significant cardiovascular disease, including but not limited to:\n\n  * New York Heart Association (NYHA) class III-IV heart failure;\n  * Myocardial infarction or coronary artery bypass grafting (CABG) within 6 months prior to enrollment;\n  * Clinically significant ventricular arrhythmias or unexplained syncope (excluding vasovagal or dehydration-related causes);\n  * Severe cardiomyopathy;\n* History of or concurrent other malignancies (except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix);\n* Clinically significant central nervous system disorders (e.g., epilepsy, stroke, psychiatric disorders) that may affect compliance or safety;\n* Participation in another interventional clinical trial within 30 days prior to enrollment;\n* Pregnant or breastfeeding women, or subjects planning pregnancy during the study period or within 6 months after the last dose and unwilling to use effective contraception;\n* Known or suspected drug abuse or alcohol dependence;\n* Requirement for concomitant use of strong CYP3A inhibitors or inducers that cannot be discontinued or dose-adjusted per protocol;\n* Any other condition that, in the investigator's opinion, would make the subject unsuitable for participation.","70 Years",{"count":60,"type":21},10,[62],"PHASE2","This is a prospective, single-arm, exploratory study evaluating the combination of Bugitinib, Venetoclax, and Cytarabine in adult patients with relapsed or refractory acute myeloid leukemia (AML), excluding M3 subtype. The primary objective is to assess the rate of MRD (Minimal Residual Disease) negativity and the duration of MRD-negative status following treatment. Secondary objectives include evaluating overall response rate (CR\u002FCRi), overall survival, progression-free survival, and safety. Treatment consists of induction therapy with Bugitinib and Venetoclax orally for 28 days combined with Cytarabine intravenously for 7-10 days per cycle. Patients who do not achieve complete remission after the first cycle may receive a second cycle with dose-adjusted Cytarabine. MRD and bone marrow assessments will guide therapy continuation, consolidation, or maintenance. Safety and tolerability will be closely monitored throughout the study.",[27,28],"2026-04-28",{"date":67,"type":42},"2026-05-01",{"date":69,"type":42},"2026-04-21",{"date":71,"type":21},"2029-06-30",{"name":73,"class":49},"Shenzhen University General Hospital",1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":74},"100525726","tbiflubumel-combined-with-secondary-ucbt-in-patients-with-hematological-malignancies-who-relapsed-after-allo-hsct-100525726","NCT06125483","TBI\u002FFlu\u002FBu\u002FMel Combined With Secondary UCBT in Patients With Hematological Malignancies Who Relapsed After Allo-HSCT","A Clinical Study of Low-dose Total Body Irradiation and Fludarabine\u002FBusulfan\u002FMelphalan as a Conditioning Regimen for Secondary Umbilical Cord Blood Transplantation in Patients With Hematological Malignancies Who Relapsed After Allo-HSCT","Inclusion Criteria:\n\n1. Gender is not limited, patients between 10 to 65 years old (including critical value);\n2. According to the WHO diagnostic criteria, the diagnosis of hematological malignancies ( acute lymphoblastic leukemia, acute \u002F chronic myeloid leukemia, etc. ) was confirmed by bone marrow puncture or biopsy after allogeneic hematopoietic stem cell transplantation. The definition of relapse includes the proportion of bone marrow blast cells \\> 5 %, blast cells in peripheral blood ( excluding the use of G-CSF and GM-CSF ), or extramedullary leukemia infiltration;\n3. Planned to received umbilical cord blood transplantation;\n4. The indexes of cardiac function, liver and kidney function were within the following limits:(1) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3× Upper limit of normal (ULN); (2)Total bilirubin ≤ 3×ULN; (3) Serum creatinine ≤ 2×ULN or creatinine clearance ≥ 40mL\u002Fmin; (4) Left ventricular ejection fraction (LVEF) as measured by echocardiography or multi-gated acquisition (MUGA) scan is within the normal range (\\> 50%);\n5. Umbilical cord blood with HLA match ≥ 6\u002F10;\n6. Expected survival ≥3 months;\n7. Karnofsky (KPS) score ≥60%, Eastern Tumor Cooperative group (ECOG) status ≤ 2;\n8. Patient fully understood the nature of the study, and voluntarily participates and signs informed consent.\n\nExclusion Criteria:\n\n1. Patients had serious adverse reactions to investigational drugs such as allergies;\n2. Patient was complicated with pulmonary infection, which was confirmed by imaging to be progressive;\n3. Patients with hypertension, ventricular arrhythmia requiring clinical intervention, acute coronary syndrome, congestive heart failure, stroke, or other grade III or higher cardiovascular events within 6 months;\n4. Patients with active viral infections, including HIV, HBV, HCV, TP;\n5. Pregnant or lactating patients;\n6. The patient is currently participating in another clinical studies;\n7. Patients deemed unsuitable for inclusion by other investigators.","10 Years","65 Years",{"count":85,"type":21},38,[87],"NA","About 33% of patients with myeloid or lymphoid malignancies experience relapse with HLA loss after haplo-HSCT. Due to the specificity of HLA-loss relapse, the 2019 European Society for Blood and Marrow Transplantation (EBMT) pointed out that for diagnosed HLA-loss patients, it is recommended to use different HLA-haploidentical donors, and lymphocyte infusions from the original donor cannot improve the prognosis. Clinical studies have found that second transplantation can achieve prolonged disease-free survival than chemotherapy for patients with HLA loss, and it may be an effective treatment strategy for these patients.\n\nHowever, due to the high standard of second hematopoietic stem cell transplantation (HSCT), not all patients can find suitable donors. Since the first successful application of umbilical cord blood transplantation (UCBT) by Gluckman et al. in France in 1988 for the treatment of Fanconi anemia, umbilical cord blood (UCB) has been widely used as a reliable source for HSCT in the treatment of hematological diseases. In 1998, Professor Yongping Song led the first successful UCBT in the treatment of leukemia, opening up the path of it in China. Compared with peripheral blood stem cell transplantation (PBST), UCBT has a higher engraftment rate. UCB contains more primitive and purer stem cells than bone marrow hematopoietic stem cells. UCBT can be performed with only 4 HLA matches, and the degree of rejection, the risk of disease relapse, and the incidence of chronic graft-versus-host disease (cGVHD) are all relatively low, greatly improving the survival of patients.\n\nAlthough UCBT has been a potential treatment for second transplantation, the effective conditioning regimen is still under discussion. Improving the incidence of engraftment , the tolerance of conditioning, and reducing transplant-related mortality (TRM) are issues of great concern in second transplantation. A standard RIC regimen composed of fludarabine (200mg\u002Fm2) combined with cyclophosphamide (50mg\u002Fkg) and 2Gy or 3Gy total body irradiation (TBI) is the most common conditioning regimen used in UCBT. Although the tolerance of this RIC is acceptable, the relapse rate after transplantation is relatively high, and the implantation failure rate is also high in high-risk populations. The inclusion of thiotepa (10mg\u002Fkg) combined with fludarabine, cyclophosphamide, and 4Gy TBI in an intensified version of the RIC regimen has improved the engraftment rate without increasing TRM. In addition, studies have also confirmed that increasing the dose of TBI can improve engraftment in transplant recipients at high risk of UCBT failure. The fludarabine\u002Fbusulfan\u002Fmelphalan (Flu\u002FBu\u002FMel) conditioning regimen was first used for salvaging UCBT in unresponsive hematological malignancies in 2016 and achieved good clinical outcomes. Subsequently, several transplant centers in Japan adopted the Flu\u002FBu\u002FMel conditioning regimen for UCBT and confirmed that, compared with the Flu\u002FBu4 regimen, it not only improved overall survival (OS) but also reduced disease relapse rate without increasing TRM. A recent multicenter retrospective study of UCBT in patients with acute myeloid leukemia in remission found that compared with the TBI\u002FCy conditioning regimen, the Flu\u002FBu\u002FMel conditioning regimen improved the engraftment rate and exerted the GVL effect, reducing NRM and improving OS.\n\nBased on the above, TBI\u002FFlu\u002FBu\u002FMel as a conditioning regimen for secondary UCBT in patients with hematological malignancies who relapsed after allo-HSCT is safe and feasible, and is expected to improve the prognosis of these patients. Therefore, based on existing clinical experience with research evidence, our center plans to conduct a clinical study of low-dose TBI and FBM as a conditioning regimen for secondary UCBT in patients with hematological malignancies who relapsed after allo-HSCT, observing the improvement in the cumulative incidence of engraftment, disease relapse, GVHD, and survival rate in patients who received this regimen.",[90,28,91],"Hematopoietic Malignancy","Hematopoietic Stem Cell Transplantation",[93,94,95,96],"Umbilical Cord Blood Transplantation","Conditioning Regimen","Secondary transplantation","Post-transplant Relapse","2025-04-21",{"date":99,"type":42},"2025-04-24",{"date":101,"type":42},"2023-11-01",{"date":103,"type":21},"2026-10-31",{"name":105,"class":49},"The First Affiliated Hospital of Soochow University",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":116,"conditions":117,"keywords":122,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":136},"100540447","phase-2-safety-and-efficacy-of-avapritinib-in-relapsed-or-refractory-pediatric-cbf-aml-with-kit-mutation-100540447","NCT06316960","Safety and Efficacy of Avapritinib in Relapsed or Refractory Pediatric CBF-AML With KIT Mutation","A Prospective, Multicenter Clinical Study on The Safety and Efficacy of Avapritinib in The Treatment of Relapsed\u002FRefractory Pediatric Core Binding Factor Acute Myeloid Leukemia (CBF-AML) With KIT Mutation","Inclusion Criteria:\n\n1. Gender unlimited;\n2. Under 18 years;\n3. Diagnosis of acute myeloid leukemia (according to the 2022 WHO classification).\n4. Presence of t(8;21)\u002FRUNX1::RUNX1T1 or inv(16)\u002Ft(16;16)\u002FCBFβ::MYH11;\n5. KIT mutation;\n6. Refractory AML: AML patients who do not achieve CR or CRi after induction therapy;\n7. Relapsed AML: patients who achieved remission after consolidation therapy or transplantation, FISH confirmed that the fusion gene turned positive, or extramedullary leukemia infiltration;\n8. No active infections;\n9. Liver function: Tbil ≤2×ULN, ALT\u002FAST ≤3×ULN, creatinine clearance ≥50ml\u002Fmin;\n10. ECOG score \\\u003C2;\n11. Expected survival time \\>12 weeks;\n12. Participants must have the ability to understand and be willing to participate in this study and must sign an informed consent form.\n\nExclusion Criteria:\n\n1. Have received prior treatment with avapritinib;\n2. Receiving other targeted therapies for AML at the same time, such as dasatinib, sorafenib, gilteritinib, venetoclax, etc;\n3. Presence of active uncontrolled infection (including bacterial, fungal, or viral infection);\n4. Present of significant underlying organ diseases: such as myocardial infarction, chronic heart failure, decompensated liver or kidney dysfunction；\n5. With other malignancies requiring treatment；\n6. Already enrolled in another interventional clinical study；\n7. The researchers determined that the individual is not suitable to participate in this trial.",{"count":114,"type":21},50,[62],"The purpose of this study is to evaluate the efficacy and safety of avapritinib in relapsed or refractory pediatric core binding factor acute myeloid leukemia with KIT mutation.",[118,28,119,120,121],"AML, Childhood","Refractory AML","Core Binding Factor Acute Myeloid Leukemia","C-KIT Mutation",[123,124,125,126,30],"Avapritinib","KIT","CBF AML","Childhood","2024-08-21",{"date":129,"type":42},"2024-08-22",{"date":131,"type":42},"2024-03-01",{"date":133,"type":21},"2027-03",{"name":135,"class":49},"Children's Hospital of Soochow University",12,{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":17,"minAge":144,"maxAge":145,"enrollmentInfo":146,"targetDuration":4,"studyType":22,"phases":148,"briefSummary":149,"conditions":150,"keywords":152,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":74},"100536250","combined-relapse-prediction-model-for-resectable-non-small-cell-patients---a-prospective-clinical-feasibility-trial-100536250","NCT06262386","Combined Relapse Prediction Model for Resectable Non-Small Cell Patients - a Prospective Clinical Feasibility Trial","Utilizing Perioperative Variation Trends of Circulating Tumor Cells and Tumor Pathological Characteristics as a Combined Relapse Prediction Model for Resectable Non-Small Cell Patients - a Prospective Clinical Feasibility Trial","Inclusion Criteria:\n\n1. Patients who presented with resectable disease ( Clinical stage 1a to 3a)\n2. Patients who received tumor resection\n\nExclusion Criteria:\n\n1. Pathologic stage greater than stage 3b or 4\n2. Pathologic stage less than stage 1a1\n3. Could not complete treatment course\n4. Could not receive blood sampling for CTC (circulating tumor cell) or regular surveillance","20 Years","90 Years",{"count":147,"type":21},358,[87],"For patients with lung cancer who have undergone tumor resection, early relapse significantly impacts survival. However, there are currently no reliable screening or imaging tools available to identify patients at risk of early relapse. To address this clinical challenge, many studies have focused on understanding the clinicopathologic characteristics associated with an increased risk of early relapse. Despite these efforts, we can identify patients at risk but cannot pinpoint which individuals will actually experience early relapse. Studies on adjuvant therapy have shown improved survival in cases of more advanced disease but have not demonstrated a reduction in early relapse rates.\n\nIn our preliminary analysis of previous study data, we observed that patients with a smaller reduction in circulating tumor cells (CTCs) within the first three days after surgery, followed by an increase on the third-day post-operation, are more likely to experience early relapse during regular monitoring. This pattern may be indicative of minimal residual disease. By combining trends in circulating tumor cell variations with pathologic characteristics, we aim to select patients for adjuvant therapy who are at high risk of developing early relapse.\n\nThe objective of our study is to employ screening based on circulating tumor cell dynamics and pathologic features to identify patients likely to experience early relapse and to assess the effectiveness of adjuvant therapy in these cases.",[151,28],"Lung Cancer",[153,154,155],"Circulating tumor cell","resectable non-small cell lung cancer","Early relapse","2024-02-07",{"date":158,"type":42},"2024-02-16",{"date":160,"type":42},"2023-08-01",{"date":162,"type":21},"2028-07-31",{"name":164,"class":49},"Chang Gung Memorial Hospital"]