[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568813":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":22,"centralContacts":31,"locations":37,"responsibleParty":52,"collaborators":22,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":22,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":22,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":77,"overallStatus":40,"whyStopped":22,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"combination therapy","EXPERIMENTAL","There is only 1 arm. Combination therapy arm included venetoclax combined with hypomethylating agents such as azacitidine or decitabine. 1. venetoclax: 400mg\u002Fd, po, days 1-7 of each 28-day cycle. 2.For patients without TP53 mutation, azacitidine was administered: 32mg\u002Fm2\u002Fd, ih, days 1-5 of each 28-day cycle; for patients with TP53 mutation, decitabine was administered: 5mg\u002Fm2\u002Fd, iv, days 1-5 of each 28-day cycle.",[13,14,15],"Drug: Azacitidine (AZA) Days 1 - 5","Drug: Decitabine (DAC)","Drug: Venetoclax",[17,23,27],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","Azacitidine (AZA) Days 1 - 5","Azacitidine, ih, 32mg\u002Fm2\u002Fd, days 1-5 of each 28-day cycle",[9],null,{"type":18,"name":24,"description":25,"armGroupLabels":26,"otherNames":22},"Decitabine (DAC)","decitabine, 5mg\u002Fm2\u002Fd, days 1-5 of each 28-day cycle.",[9],{"type":18,"name":28,"description":29,"armGroupLabels":30,"otherNames":22},"Venetoclax","venetoclax, 400mg\u002Fd, days 1-7 of each 28-day cycle",[9],[32],{"name":33,"role":34,"phone":35,"phoneExt":22,"email":36},"Xianmin Song","CONTACT","+8613501672508","shongxm@139.com",[38],{"facility":39,"status":40,"city":41,"state":22,"zip":22,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Shanghai General Hospital","RECRUITING","Shanghai","China","CN",{"type":45,"coordinates":46},"Point",[47,48],121.45806,31.22222,{"lat":48,"lon":47},[51],{"name":33,"role":34,"phone":35,"phoneExt":22,"email":36},{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","Xianmin Song, MD","Professor","100568813","phase-2-demethylating-agents-combined-with-venetoclax-for-high-risk-t-cell-lymphoblastic-lymphomaleukemia-post-transplant-relapse-prevention-100568813",false,"NCT06686108","Demethylating Agents Combined With Venetoclax for High-risk T-cell Lymphoblastic Lymphoma\u002FLeukemia Post-Transplant Relapse Prevention","Safety and Efficacy Study of Demethylating Agents With Venetoclax in Preventing Recurrence of High-risk T-cell Lymphoblastic Lymphoma\u002FLeukemia After Transplantation","Inclusion Criteria:\n\n* 1.14-55 years old, male,or female.\n* 2.Patients with allo-HSCT due to T-LBL\u002FALL, the donor type is not limited.\n* 3.ECOG score is 0-2 points.\n* 4.Blood routine: ANC ≥ 1.0 × 109\u002FL, PLT ≥ 50 × 109\u002FL.\n* 5.One of the following high-risk factors:\n* a. Age of initial diagnosis ≥ 35 years old.\n* b. Initial diagnosis of WBC ≥ 100 × 109\u002FL.\n* c. Initial diagnosis of LDH exceeding the upper limit of normal values.\n* d. Initial diagnosis of bone marrow involvement (blast cells ≥ 5%).\n* e. Initial diagnosis of a bulky in the mediastinum (longest diameter ≥ 10cm).\n* f. ETP immunophenotype.\n* g. During the induction chemotherapy process, 2 courses did not achieve partial remission and\u002For 4 courses did not achieve complete remission.\n* h. Residual lesions before transplantation: Flow cytometry analysis showed that the proportion of abnormal lymphoid cells in the bone marrow was greater than 0.01%; Positive detection of minimal residual lesions in molecular biology; PET-CT scan shows that residual lesions are still active.\n* i. Based on the ELN recommendation based on adult T-ALL: gene mutations involving myeloid related genes, RAS\u002FPI3K\u002FAKT, JAK\u002FSTAT signaling pathway, and epigenetics, such as FLT3, NRAS\u002FKRAS, PTEN, IL7R, JAK1, JAK3, DNMT3A, IDH1, IDH2; TP53, BCL2 mutations; t (8; 14) (q24; q11)\u002FMYC rearrangement; t (7; 19) (q34; p13)\u002FTCR-LYL1，TCR-MEF2C; del(5q) (q14).\n* j. High risk subgroups based on NGS definition: PI3K signaling pathway\u002FNRAS, KRAS\u002FTP53\u002FIKZF1\u002FDNTM3A\u002FIDH1, IDH2 gene mutation with or without NOTCH1, FBXW7\u002FPHF6\u002FEP300 gene mutation.\n\nExclusion Criteria：\n\n* 1.Central involvement during any course of the disease.\n* 2.Patients who have not achieved complete remission before transplantation.\n* 3.Identify those with available targeted drugs.\n* 4.For those who are resistant to BCL-2 inhibitors before transplantation, if the disease progresses during the application process, or if 3-4 courses of induction therapy containing BCL2 inhibitors do not improve.\n* 5.Individuals who are known to be allergic to demethylating drugs or venetoclax.\n* 6.Individuals with grade 2 or more degrees of active acute GVHD.\n* 7.Individuals with moderate to severe chronic GVHD.\n* 8.T-LBL\u002FALL relapse (flow cytometry abnormal lymphocyte cell proportion\\>0.01%, WT1 positive, fusion gene positive, or extramedullary recurrence), or transplant rejection, bone marrow donor cell chimerism\\\u003C95%.\n* 9.Blood routine: ANC\\\u003C1.0 × 109\u002FL or PLT\\\u003C50 × 109\u002FL.\n* 10.Combined with severe organ dysfunction; The ratio of aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) is more than 3 times the normal value or the normal value of direct bilirubin is more than 3 times; The endogenous creatinine clearance rate (Ccr) is less than 50mL\u002Fmin or 1.5 times the normal value of blood creatinine, regardless of whether hemodialysis treatment is used.\n* 11.Merge severe active infections.\n* 12.Pregnant or lactating women.\n* 13\\. Accepting other investigational drugs.\n* 14.According to the researchers' assessment, the patient may have complications that could lead to other dangers.","ALL","14 Years","55 Years",{"count":67,"type":68},59,"ESTIMATED","INTERVENTIONAL",[71],"PHASE2","This study is a prospective, phase II clinical trial with the primary objective of assessing the effectiveness of demethylating agents combined with venetoclax in the prevention of recurrence after allogeneic hematopoietic stem cell transplantation (allo-HSCT) of high risk T-lymphoblastic lymphoma\u002Fleukemia (T-LBL\u002FALL) patients.",[74,75,76],"T-cell Acute Lymphoblastic Leukemia","ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION","Relapse",[78,79,80],"T-cell lymphoblastic lymphoma\u002Fleukemia","relapse","allogeneic hematopoietic stem cell transplantation","2025-05-04",{"date":83,"type":84},"2025-05-07","ACTUAL",{"date":86,"type":84},"2024-10-30",{"date":88,"type":68},"2028-10-30",{"name":5,"class":6},1]