[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"t-cell-lymphoblastic-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:t-cell-lymphoblastic-lymphoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,77],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100491602","phase-3-capizzi-escalating-methotrexate-versus-high-dose-methotrexate-in-children-with-newly-diagnosed-t-cell-lymphoblastic-lymphoma-t-lbl-100491602",false,"NCT05681260","Capizzi Escalating Methotrexate Versus High Dose Methotrexate in Children With Newly Diagnosed T-cell Lymphoblastic Lymphoma (T-LBL)","A Randomized Trial Using a Modified COG ABFM Regimen Backbone to Investigate Capizzi Escalating Methotrexate Versus High Dose Methotrexate in Children With Newly Diagnosed T-cell Lymphoblastic Lymphoma (T-LBL)","Inclusion Criteria:\n\n* Newly diagnosed T-lineage lymphoblastic lymphoma (T-LBL) Stage II-IV\n\nExclusion Criteria:\n\n* Patients with Down syndrome or primary immune comprised disease.\n* Ph+ T-LBL\n* Patients must not have received any prior cytotoxic chemotherapy\n* Any steroids pretreatment for \\> 5 days in the 7 days or for \\>14 days in the 28 days before the initiation of Induction chemotherapy. The dose of prednisone or methylprednisone pretreatment does not affect eligibility. Any steroids exposure that occurred \\> 28 days before the initiation of Induction chemotherapy is allowed. Inhalation and topical steroids are not considered pretreatment. A single dose of vincristine is allowed.","ALL","12 Months","18 Years",{"count":20,"type":21},200,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","T-cell lymphoblastic lymphoma (T-LBL) is the second most common subtype of non-Hodgkin lymphoma (NHL) in children and adolescents. With current treatment, event-free survival (EFS) rates vary between 75%\\~85%. Two different MTX intensification strategies are used commonly: HD-MTX with leucovorin rescue, and Capizzi-style MTX without leucovorin rescue plus PEG-ASP (C-MTX). Although superior outcome of patients with T-ALL receiving C-MTX compared with HD-MTX on the AALL0434 trial, the 2 approaches had not been compared directly in patients with T-LBL. There remains controversy on PET\u002FCT interpretation in children with NHL. Large prospective studies in pediatric patients with T-LBL regarding PET\u002FCT value for this is scarce. Around 1% pediatric patients with T-LBL will not achieve remission at the end of Induction (induction failure). The optimal treatment for this small subgroup is largely unclear. The BFM HR Blocks usually are applied to these patients even though the efficacy is unknown. Novel targeted therapies are needed for use. Dasatinib is identified as a targeted therapy for T-cell ALL in preclinical drug screening.",[27],"T-cell Lymphoblastic Lymphoma",[29,30,31,32,33,34,35,36],"T-cell lymphoblastic lymphoma","Pediatric","Capizzi-style Methotrexate","High dose Methotrexate","bortezomib","treatment","survival","PET scan","RECRUITING","2026-03-17",{"date":40,"type":41},"2026-03-19","ACTUAL",{"date":43,"type":41},"2023-02-06",{"date":45,"type":21},"2029-12-31",{"name":47,"class":48},"Children's Cancer Group, China","NETWORK",2,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":76},"100559203","phase-2-a-phase-2-study-to-evaluate-efficacy-of-calaspargase-pegol-mknl-and-decitabine-combined-with-venetoclax-in-pediatric-adolescent-and-young-adult-patients-with-relapsedrefractory-t-cell-acute-lymphoblastic-leukemia-t-all-and-t--cell-lymphoblastic-lymphoma-t-lly-100559203","NCT06561074","A Phase 2 Study to Evaluate Efficacy of Calaspargase Pegol-mknl and Decitabine Combined With Venetoclax in Pediatric, Adolescent, and Young Adult Patients With Relapsed\u002FRefractory T-cell Acute Lymphoblastic Leukemia (T-ALL) and T- Cell Lymphoblastic Lymphoma (T-LLy)","Inclusion Criteria:\n\n1. Pediatric, adolescent, or young adult patients who have relapse or refractory T-cell lymphoblastic leukemia (T-ALL) or T-Cell lymphoblastic lymphoma (T-LLy) according to 2017 WHO classification and NCCN v1 2021.\n2. Patients have adequate performance status (ECOG ≤2) for patients≥16 years old, Lansky score \\>50 for patients\\\u003C16 years old.\n3. Patients must be 1mo to 21 years of age at time of signing\u002For having proxy sign the informed consent.\n4. Patients with asymptomatic CNS disease are eligible (see also Exclusion Criterion #2 in section 4.2.)\n5. The following conditions are allowed on study: conditions requiring systemic glucocorticoid use, such as autoimmune disease, acute or chronic controlled graft versus host disease (GVHD) or severe asthma. Patients are also allowed up to 5 days of glucocorticoids as cytoreduction in combination with up to 3 doses of cyclophosphamide (200 mg\u002Fm2\u002Fday) are allowed as standard pre-phase treatment up to 1 day before start of study treatment or cytarabine up to 2gm\u002Fm2. This can also be discussed with PI.\n6. Patients must have adequate organ function and laboratory results (obtained within 14 days of enrolment:\n\n   1. Total serum bilirubin ≤1.5 x upper limit of normal (ULN). Patients with known Gilbert's syndrome may have a total bilirubin up to ≤3 x ULN.\n   2. Adequate renal function (creatinine clearance ≥ 30 mL\u002Fmin) unless related to disease.\n   3. Alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) ≤3 x ULN; ≤5 x ULN unless in case of suspected leukemic liver involvement\n   4. Amylase, Lipase and Triglycerides must be WNL prior to administration of calaspargase pegol-mknl. If the lab values are outside the normal range, the treating physicians can discuss dosing\u002Fenrolling per PI discretion.\n7. Females of childbearing potential must have a negative serum or urine beta-human chorionic gonadotropin (β-HCG) pregnancy test result within 14 days prior to the first dose of study drugs and must agree to use one of the following effective contraception methods during the study and for 3 months following the last dose of study drug. Effective methods of birth control include:\n\n   1. Birth control pills, skin patches, birth control injections, implants (placed under the skin by a health care provider)\n   2. Intrauterine devices (IUDs) and intra-uterine hormone-releasing systems (IUS)\n   3. Condom\n   4. Abstinence\n   5. Bilateral tubal occlusion\u002Fligation or Bilateral tubal occlusion\u002Fligation by hysteroscopy with a hysterosalpingogram to confirm the procedure's success\n8. Males need to inform the doctor right away if the partner becomes pregnant or suspects pregnancy. While in this study and for 90 days after the last treatment the patient should not donate sperm for the purposes of reproduction. He will need to use a condom while in this study and for 90 days after the last treatment.\n9. Patients must have had at least 30 days between prior hematopoietic stem cell transplant and first dose of study drug.\n10. Patients able and willing to swallow tablets or use oral dispersible tablets. No liquid formulation is available.\n\nExclusion Criteria:\n\n1. Past or current history of a secondary or other primary tumor or a chronic myeloid leukemia (CML) blast crisis with exception of:\n\n   uratively treated non-melanomatous skin cancer, other primary solid tumor treated with curative intent and no known active disease present, and no treatment administered during the last 2 years\n2. Presence of clinically significant uncontrolled CNS pathology such as epilepsy, paresis, aphasia, stroke, severe brain injuries, organic brain syndrome, or psychosis.\n\n   Presence of the following are allowed: headaches, vomiting, nerve palsy\n3. Significant traumatic injury or major surgery (major surgery means opening of a body cavity, e.g., thoracotomy, laparotomy, laparoscopic organ resection, and major orthopedic procedures, e.g. joint replacement, open reduction, and internal fixation) within 14 days of scheduled dosing day 1.\n4. Male or female subjects of childbearing potential, unwilling to use an approved, effective means of contraception in accordance with institution's standards.\n5. Patients with uncontrolled infections (viral, bacterial, or fungal) per PI's discretion. Infections controlled on concurrent anti-microbial agents are acceptable, and anti-microbial prophylaxis per institutional guidelines are acceptable.\n6. Medical history of cardiovascular disease such as:\n\n   Clinically significant cardiac disease including congestive heart failure (NYHA class III or IV), arrhythmia or conduction abnormality requiring medication, or cardiomyopathy.\n7. Female patient who is pregnant or breastfeeding. Female patient who is considering becoming pregnant during the study; or within approximately 30 days after the last dose of venetoclax, 3 months after the last dose of calaspargase or 6 months after the last dose of decitabine. For decitabine and calaspargase, also see the study drugs product label for pregnancy precautions. Male patient who is considering fathering a child within approximately 30 days or donating sperm during the study, within approximately 90 days after the last dose to venetoclax, calaspargase and decitabine. For all study drugs, also see the relevant chemotherapy product label for not fathering a child and donating sperm.\n8. Patients may be excluded if they are currently enrolled in another ongoing clinical trial with investigational products\n9. Liver cirrhosis or other active severe liver disease or with suspected active alcohol abuse.\n10. Patients who are unable or unwilling to comply with all study requirements for clinical visits, examinations, tests, and procedures.\n11. If patient has not recovered from grade 2 clinically significant adverse effect(s)\u002Ftoxicity(s) of the previous therapy- (exception no grade 3 or higher peripheral neuropathy) from previous chemotherapy, surgery, radiation before the start of study drugs.\n12. Pancreatitis: Patients will be excluded in the presence of Grade 3 or 4 pancreatitis or if history of anaphylaxis or grade 3 pancreatitis from asparaginase.\n13. Other severe, uncontrolled acute or chronic medical or psychiatric condition or laboratory abnormality that in the opinion of the Investigator may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and\u002For would make the patient inappropriate for enrollment into this study.\n14. History of serious hypersensitivity reactions including anaphylaxis to pegylated L-Asparaginase therapy.\n15. Known history of coagulopathy (e.g., hemophilia and know protein S deficiency).\n16. Active thromboembolic event(s) (i.e., symptomatic despite initiation of anti-coagulation therapy), or history of CNS thromboses.\n17. Patients should not have received the following within 7days prior to the first dose of study drug: Strong and moderate CYP3A inducers.\n18. Malabsorption syndrome or any other condition that precludes enteral administration.\n19. Has consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Star fruit or used a strong or moderate CYP3A inhibitor within 2 days prior to the first dose of venetoclax.","1 Month","21 Years",{"count":59,"type":21},22,[61],"PHASE2","To learn if giving the study drugs calaspargase pegol-mknl and decitabine in combination with venetoclax can help to control relapsed\u002Frefractory T-ALL and T-LLy. The safety of this drug combination will also be studied.",[64,65],"T-cell Acute Lymphoblastic Leukemia","T-Cell Lymphoblastic Lymphoma","2026-03-12",{"date":68,"type":41},"2026-03-16",{"date":70,"type":41},"2025-09-25",{"date":72,"type":21},"2031-12-31",{"name":74,"class":75},"M.D. Anderson Cancer Center","OTHER",1,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":76},"100616059","phase-1-anti-ccr9-car-t-cells-for-t-cell-leukaemialymphoma-100616059","NCT07300683","Anti-CCR9 CAR T Cells for T Cell Leukaemia\u002FLymphoma","Fratricide-Resistant Autologous Chimeric Antigen Receptor T Cells Targeting CCR9 for the Treatment of T Cell Acute Lymphoblastic Leukaemia\u002F Lymphoma","FRACTALL","Key Inclusion Criteria:\n\n* Relapsed or refractory T-ALL\u002FT-LBL following at least one (≥18 years old) or two (\\\u003C18 years old) standard prior lines of combination cytotoxic therapy\n* CCR9-positive disease as assessed by flow cytometry\n* T-LBL patients only: Patients must have measurable disease\n* Agreement to have a pregnancy test, use adequate contraception (if applicable)\n* Written informed consent\n\nKey Exclusion Criteria:\n\n* ECOG performance score \\>2 (patients aged ≥10 years old) OR Lanksy score ≤50% (patients aged \\\u003C10 years old)\n* Stem Cell Transplant patients only: active significant acute GvHD or moderate\u002Fsevere chronic GvHD requiring immunosuppressive therapy and\u002For systemic steroids\n* Active CNS involvement of disease\n* Active hepatitis B, C or HIV infection\n* Oxygen saturation ≤90% on air\n* Bilirubin \\>3 x upper limit of normal\n* GFR \\\u003C30 ml\u002Fmin\n* Cardiac dysfunction\n* Patients receiving corticosteroids at a supraphysiological dose that cannot be discontinued\n* Known allergy to any component of the ATIMP\n* Any contraindications to lymphodepletion or to the use of cyclophosphamide or fludarabine as per local SmPC\n* Women who are pregnant or breastfeeding\n* Life expectancy \\\u003C3 months\n* Fulminant or rapidly progressive disease",{"count":86,"type":21},24,[88],"PHASE1","The goal of this clinical trial is to learn if anti-CCR9 CAR T cells (which will be made using the patient's own blood cells) are safe and which dose should be used in children and adults with T cell leukaemia and lymphoma.\n\nParticipants will:\n\n* have T cells collected from their blood and these T cells will be used to make the CAR-T cells in a specialized laboratory.\n* be admitted at the hospital a week before the CAR T cells infusion to receive a short course of chemotherapy drugs which prepare the body to receive the CAR T cells.\n* be given the CAR T cells into their vein.\n* stay in the hospital for a minimum of 2 weeks to be closely monitored\n* following discharge, participants will come to the clinic for check-ups (approximately 12 visits in the first two years)\n* during screening, treatment and follow up visits, participants will have physical examination, collection of blood samples and bone marrow biopsies and\u002For imaging tests (CT\u002FPET-CT scans) depending on their type of T-cell cancer.",[91,92],"T Cell Acute Lymphoblastic Leukemia","T Cell Lymphoblastic Lymphoma",[83,94,95,96],"Fratricide-Resistant","CCR9","CAR T cells","2025-12-17",{"date":99,"type":41},"2025-12-24",{"date":101,"type":41},"2025-11-11",{"date":103,"type":21},"2042-12",{"name":105,"class":75},"University College, London"]