[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"t-cell-acute-lymphoblastic-leukemialymphoblastic-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:t-cell-acute-lymphoblastic-leukemialymphoblastic-lymphoma":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,38,74],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":4},"100638295","autologous-versus-allogeneic-hematopoietic-stem-cell-transplantation-for-t-lymphoblastic-leukemialymphoma-in-first-complete-remission-100638295",false,"NCT07577531","Autologous Versus Allogeneic Hematopoietic Stem Cell Transplantation for T-Lymphoblastic Leukemia\u002FLymphoma in First Complete Remission","* Inclusion Criteria:\n* Age 14-55 years, no gender restriction\n* Expected survival \\>12 weeks\n* ECOG performance status 0-2\n* Pathologically or by bone marrow flow cytometry confirmed •T-lymphoblastic lymphoma in first complete remission (CR1) after chemotherapy; CR1 criteria: first complete remission, defined as: ① For intramedullary disease, meeting the CR criteria of the 2024 Chinese Adult Acute Lymphblastic Leukemia Diagnosis and Treatment Guidelines (2024 edition) with flow cytometric\u002Fgene testing showing MRD negativity; ② For extramedullary disease, meeting the Lugano 2014 response criteria for CR with a PET-CT score of 1-2\n* Hepatic, renal, cardiac, and pulmonary function meeting the following requirements:\n\n  1. Creatinine clearance (by Cockcroft-Gault formula) ≥60 mL\u002Fmin\n  2. Cardiac ejection fraction \\>50%, with no clinically significant ECG abnormalities\n  3. Baseline oxygen saturation \\>92%\n  4. Total bilirubin ≤1.5×ULN; ALT and AST ≤3×ULN\n* Ability to understand the trial and signed informed consent\n* Exclusion Criteria:\n* Malignancies other than acute T-lymphoblastic leukemia, T-cell lymphoma, or T-lymphoblastic lymphoma within 5 years prior to screening, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery, or thyroid cancer after radical surgery.\n* Active, uncontrolled bacterial, viral, or fungal diseases requiring treatment; HBsAg or HBcAb positive with peripheral blood HBV DNA ≥ lower limit of detection; HCV antibody positive with peripheral blood HCV RNA positive; positive TRUST test for syphilis; positive HIV antibody.\n* Dysfunction of vital organs (cardiovascular, cerebrovascular, pulmonary);history of active gastrointestinal bleeding within the past 3 months; uncontrolled hypertension or history of hypertensive crisis or hypertensive encephalopathy; history or evidence of major cardiovascular risk, including any of the following: congestive heart failure, unstable angina, clinically significant arrhythmias (e.g., ventricular fibrillation, ventricular tachycardia); history of arterial thrombosis within the past 3 months (e.g., stroke, transient ischemic attack); history of symptomatic deep vein thrombosis or pulmonary embolism within the past 6 months, or history of coronary angioplasty, defibrillation, or any clinically relevant complication or disease that may pose a risk to subject safety or interfere with study assessments, procedures, or completion.\n* Any other uncontrolled active disease that precludes participation in the trial.\n* Active, uncontrolled central nervous system involvement, or subjects with a history of CNS disease requiring treatment (e.g., epilepsy patients).\n* Pregnant or breastfeeding women; subjects planning to become pregnant within 1 year after infusion, or during or after treatment.\n* Presence of uncontrolled active infection (excluding simple urinary tract infection or upper respiratory tract infection).\n* Known allergy to conditioning regimen drugs.\n* Any condition that, in the investigator's judgment, would compromise subject safety or interfere with study objectives, or subjects deemed unsuitable for participation in this trial; subjects with illnesses affecting their ability to give written informed consent or to comply with study procedures; unwilling or unable to comply with study requirements","ALL","14 Years","55 Years",{"count":19,"type":20},84,"ESTIMATED","24 Months","OBSERVATIONAL","To evaluate, through a prospective multicenter observational study, autologous or allogeneic hematopoietic stem cell transplantation (Auto-SCT\u002Fallo-SCT)as consolidation therapy in subjects with T lymphoblastic leukemia\u002FLymphoblastic lymphoma(T-ALL\u002FLBL)who have achieved first complete remission (CR). Assess relapse-free survival (RFS), overall survival (OS), cumulative incidence of relapse (CIR), and non-relapse mortality (NRM) among different treatment regimens",[25],"T Cell Acute Lymphoblastic Leukemia\u002FLymphoblastic Lymphoma","NOT_YET_RECRUITING","2026-05-10",{"date":29,"type":30},"2026-05-13","ACTUAL",{"date":32,"type":20},"2026-05-05",{"date":34,"type":20},"2029-05-05",{"name":36,"class":37},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine","OTHER",{"id":39,"slug":40,"hasResults":11,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":15,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":51,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100521077","phase-1-cd7-car-t-cells-in-pediatric-relapsedrefractory-cd7-t-allll-100521077","NCT06064903","CD7-CAR-T Cells in Pediatric Relapsed\u002FRefractory CD7+ T-ALL\u002FLL","Phase I\u002FII Study of Anti-CD7 Chimeric Antigen Receptor-Expressing T Cells in Pediatric Patients Affected by Relapsed\u002FRefractory CD7+ T-cell Acute Lymphoblastic Leukemia\u002FLymphoma","CD7-CAR01","Procurement eligibility\n\nInclusion Criteria:\n\n1. Diagnosis of CD7 expressing (\\> 98% CD7 expression on blast cells) T-ALL or LL and one of the following:\n\n   1. Patients in 1st or subsequent relapse, after at least one standard frontline chemotherapy with BM involvement (MRD \\>1% in 2 consecutive determinations or evidence of morphological relapse, i.e. \\>5% blasts in BM);\n   2. Relapse after allogeneic HSCT, if at least 100 days post-transplant, if there is no evidence of active GVHD and if the patient is no longer taking immunosuppressive agents for at least 30 days prior to enrollment;\n   3. CNS disease as defined as \\> 5 WBCs\u002FmcL in CSF with morphological\u002Fflow-cytometry evidence of blasts or biopsy proven recurrence in the eye or brain;\n   4. Extramedullary relapse as defined by morphological evidence of blasts in the testis or any other extramedullary sites;\n   5. Refractory disease, defined as MRD ≥ 1% or \\\u003C1% but persistently positive (i.e. a positive MRD value confirmed by PCR at 2 subsequent evaluations performed at least 2 weeks apart), at the end of consolidation blocks in newly diagnosed patients;\n2. Age: 6 months - 25 years.\n3. Adequate venous access for apheresis or eligible for appropriate catheter placement, and no other contraindications for leukapheresis.\n4. Voluntary informed consent is given. For subjects \\\u003C18-year-old, or below the age required by each Country regulation, their legal guardian must give informed consent. Pediatric subjects will be included in age-appropriate discussion and verbal assent will be obtained for those greater than or equal to 12 years of age, when appropriate, or to sign age-adapted informed consent, according to the regulatory requirement of each Country.\n5. Clinical performance status: Patients \\> 16 years of age: Karnofsky greater than or equal to 60%; Patients \\\u003C 16 years of age: Lansky scale greater than or equal to 60%.\n\nExclusion Criteria:\n\n1. Severe, uncontrolled active intercurrent infections.\n2. HIV, or active HCV and\u002For HBV infection.\n3. Blast contamination in peripheral blood \\>5%, by flow-cytometry, at the time of leukapheresis collection.\n4. Concurrent or recent prior therapies, before apheresis:\n\n   1. Systemic steroids (at a dose equivalent to or greater than 2 mg\u002Fkg prednisone) in the 2 weeks before apheresis collection. Recent or current use of inhaled\u002Ftopical\u002Fnon-absorbable steroids is not exclusionary\n   2. Systemic chemotherapy in the 2 weeks preceding apheresis collection\n   3. Nelarabine, daratumomab, clofarabine exposure in the 3 weeks preceding apheresis collection\n   4. Anti-thymocyte globulin (ATG) or Alemtuzumab (Campath®) in the 8 weeks preceding apheresis collection\n   5. Immunosuppressive agents in the 2 weeks preceding apheresis collection\n   6. Radiation therapy must have been completed at least 2 weeks prior to apheresis\n   7. Other anti-neoplastic investigational agents currently administered or within 30 days prior to apheresis (i.e. start of protocol therapy)\n   8. Exceptions:\n\n      * There is no time restriction with regard to prior intrathecal chemotherapy, provided that there is complete recovery from any acute toxic effects of such chemotherapy;\n      * Patients who relapse while receiving standard ALL maintenance chemotherapy will not be required to have a waiting period before entry onto this study provided they meet all other eligibility criteria;\n      * Subjects receiving steroid therapy at physiologic replacement doses only are allowed provided there has been no increase in dose for at least 2 weeks prior to starting apheresis.\n\nTreatment eligibility\n\nInclusion criteria:\n\n1. Diagnosis of CD7 expressing (\\> 98% CD7 expression on blast cells) T-ALL or LL and one of the following:\n\n   1. Patients in 1st or subsequent relapse, after at least one standard frontline chemotherapy with BM involvement (MRD \\>1% in 2 consecutive determinations or evidence of morphological relapse, i.e. \\>5% blasts in BM)\n   2. Relapse after allogeneic HSCT, if at least 100 days post-transplant, if there is no evidence of active GVHD and if the patient is no longer taking immunosuppressive agents for at least 30 days prior to enrollment\n   3. CNS disease as defined as \\> 5 WBCs\u002FmcL in CSF with morphological or flow-cytometry evidence of blasts or biopsy proven recurrence in the eye or brain\n   4. Extramedullary relapse as defined by morphological evidence of blasts in the testis or any other extramedullary sites\n   5. Refractory disease, defined as MRD ≥1% or \\\u003C1% but persistently positive (i.e. a positive MRD value confirmed by PCR at 2 subsequent evaluations performed at least 2 weeks apart), at the end of consolidation blocks in newly diagnosed patients\n2. Measurable or evaluable disease at the time of enrollment, which may include any evidence of disease, including MRD detected by flow-cytometry, cytogenetics, or polymerase chain reaction (PCR) analysis.\n3. Age: 6 months - 25 years.\n4. Before enrollment for treatment, patients must have a potential allogeneic hematopoietic stem cell (HSC) donor (matched related, matched unrelated or haploidentical) available.\n5. Voluntary informed consent is given. For subjects \\\u003C18-year-old, or below the age required according to each Country regulation, their legal guardian must give informed consent. Pediatric subjects will be included in age-appropriate discussion and verbal assent will be obtained for those greater than or equal to 12 years of age, when appropriate, or to sign age-adapted informed consent, according to the regulatory requirement of the Country.\n6. Clinical performance status: Patients \\> 16 years of age: Karnofsky greater than or equal to 60%; Patients \\\u003C 16 years of age: Lansky scale greater than or equal to 60%.\n\nExclusion criteria:\n\n1. Pregnant or lactating women.\n2. Severe, uncontrolled active intercurrent infections.\n3. HIV, or active HCV and\u002For HBV infection.\n4. Life-expectancy \\\u003C 6 weeks.\n5. Hepatic function: Inadequate liver function defined as total bilirubin \\> 4x upper limit of normal (ULN) or transaminase (ALT and AST) \\> 6 x ULN.\n6. Renal function: serum creatinine \\> 3x ULN for age.\n7. Blood oxygen saturation \\\u003C 90%.\n8. Cardiac function: Left ventricular ejection fraction lower than 45% by ECHO.\n9. Congestive heart failure, cardiac arrhythmia, psychiatric illness, or social situations that would limit compliance with study requirements or in the opinion of the PI would pose an unacceptable risk to the subject.\n10. Uncontrolled seizures or status epilepticus; increased intra-cranial pressure as evidenced by papilledema and CSF opening pressure \\> 20 cm water; decreased conscious state (any cause).\n11. Contamination of either the apheresis collection or the CD7-CART01 drug product with \\>5% blasts.\n12. Presence of active, grade 2-4 acute or extensive chronic GvHD.\n13. Concurrent or recent prior therapies, before infusion:\n\n    1. Systemic steroids (at a dose \\> 2 mg\u002Fkg prednisone) in the 2 weeks before infusion. Recent or current use of inhaled\u002Ftopical\u002Fnon-absorbable steroids is not exclusionary\n    2. Systemic chemotherapy in the 2 weeks preceding infusion\n    3. Anti-thymocyte globulin (ATG) or Alemtuzumab (Campath®) in the 8 weeks preceding infusion\n    4. Immunosuppressive agents in the 2 weeks preceding infusion\n    5. Radiation therapy must have been completed at least 3 weeks prior to enrollment\n    6. Other anti-neoplastic investigational agents currently administered or within 30 days prior to infusion (i.e., start of protocol therapy)\n    7. Exceptions:\n\n       * There is no time restriction in regards to prior intrathecal chemotherapy but there must be a complete recovery from any acute toxic effects from such chemotherapy;\n       * Patients who relapse while receiving standard ALL maintenance chemotherapy will not be required to have a waiting period before entry onto this study provided that they meet all other eligibility criteria;\n       * Subjects receiving steroid therapy at physiologic replacement doses only are allowed provided that there has been no increase in dose for at least 2 weeks prior to starting apheresis.","6 Months","25 Years",{"count":49,"type":20},26,"INTERVENTIONAL",[52,53],"PHASE1","PHASE2","The main purpose of this study is to evaluate the safety, to establish the recommended dose, and to evaluate the antitumor effect of CD7-CART01 in pediatric patients with relapsed or refractory (R\u002FR) T-cell acute lymphoblastic leukemia (T-ALL) or lymphoblastic lymphoma (T-LL).",[56],"T-Cell Acute Lymphoblastic Leukemia\u002FLymphoblastic Lymphoma",[58,59,60,61,62],"T-ALL","T-LL","Relapsed","Refractory","anti-CD7 PEBL-CAR T","RECRUITING","2025-11-25",{"date":66,"type":30},"2025-12-02",{"date":68,"type":30},"2024-04-21",{"date":70,"type":20},"2040-09-30",{"name":72,"class":37},"Bambino Gesù Hospital and Research Institute",1,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":15,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":50,"phases":86,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},"100581861","phase-2-newly-diagnosed-pediatric-t-cell-all-protocol-100581861","NCT06855810","Newly-diagnosed Pediatric T-cell ALL Protocol","Chinese Children's Cancer Group T-cell Acute Lymphoblastic Leukemia -2025 Project","CCCG-TALL-2025","Inclusion Criteria:\n\n1. Age older than 1 month to younger than 18 years.\n2. Diagnosis of acute lymphoblastic leukemia by bone marrow morphology.\n3. Diagnosis of T-ALL by immunophenotyping.\n\nExclusion Criteria:\n\n1. B-ALL\n2. AML\n3. Acute leukemias of ambiguous lineage diagnosed according to WHO or EGIL criteria.\n4. ALL evolved from chronic myeloid leukemia (CML).\n5. Down's syndrome, or major congenital or hereditary disease with organ dysfunction\n6. Secondary leukemia\n7. Known underlying congenital immunodeficiency or metabolic disease\n8. Congenital heart disease with cardiac insufficiency.\n9. Treated with glucocorticoids for ≥14 days, or ABL kinase inhibitors for \\> 7 days within one month before enrollment, or any chemotherapy or radiotherapy within 3 months before enrollment (except for emergency radiotherapy to relieve airway compression)\n10. Any significant comorbidities or psychiatric disorders that may impact patient safety, compliance, informed consent, study participation, follow-up, or the interpretation of study results. In such cases, all participating sites must report directly to the PI to determine whether the patient meets exclusion criteria.\n11. Severe malnutrition, active infections, heart failure, or chemotherapy intolerance.","1 Month","18 Years",{"count":85,"type":20},610,[53,87],"PHASE3","This is a prospective, multicenter study conducted within the Chinese Children's Cancer Group (CCCG). The study aims to evaluate whether the addition of three novel agents, dasatinib, venetoclax and homoharringtonine, can improve the minimal residual disease (MRD)-negative remission rate, enhance event-free survival (EFS), and reduce the cumulative incidence of relapse (CIR) in pediatric patients with newly diagnosed T-cell acute lymphoblastic leukemia (T-ALL).",[90,91,25],"Acute Lymphoblastic Leukemia","Childhood Leukemia, Acute Lymphoblastic",[93,94,95],"dasatinib","venetoclax","homoharringtonine","2025-08-23",{"date":98,"type":30},"2025-08-26",{"date":100,"type":30},"2025-03-11",{"date":102,"type":20},"2031-06",{"name":104,"class":37},"Institute of Hematology & Blood Diseases Hospital, China",27]