[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-lymphoblastic-leukemia-all\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-lymphoblastic-leukemia-all":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,24,0,[8,43,74,113,151,174,202,231,255,283,319,345,372,406,431,464,492,516,545,576,602,624,649,671],{"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":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100607635","transcutaneous-auricular-vagus-nerve-stimulation-for-insomnia-in-survivors-of-childhood-acute-lymphoblastic-leukemia-100607635",false,"NCT07191119","Transcutaneous Auricular Vagus Nerve Stimulation for Insomnia in Survivors of Childhood Acute Lymphoblastic Leukemia","Feasibility and Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation for Insomnia in Survivors of Childhood Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* Survivor of Acute Lymphoblastic Leukemia (ALL)\n* Enrolled on SJLIFE\n* Participant was less than 21 years of age at time of diagnosis.\n* Age 20-50 years at the time of enrollment\n* Insomnia Severity Index \\>=8 (Proxy \\>=8) confirmed prior to enrollment\n* Access to home Wi-Fi and Smartphone\n* Participant is able to speak and understand the English language\n* Participant is able and willing to give consent\n\nExclusion Criteria:\n\n* Unable to understand the details and requirements of the study (at the discretion of the PI)\n* Female participants who are pregnant or planning to become pregnant\n* Presence of implanted electrical medical devices (i.e. pacemaker)\n* Currently taking medication intended to treat neurocognitive impairment (i.e. stimulants) or medications prescribed for seizure management\n* History of skin irritation or other issues during stimulation of inner ear\n* Currently utilizing a technological intervention for a sleep disorder (e.g. CPAP)\n* Medications and behavioral practices (white noise, night-time yoga, etc) are acceptable as long as the insomnia is persistent.\n* History of a contraindicated health condition including:\n* Syncope (CTCAE \\>2)\n* Cardiac dysrhythmia (CTCAE \\>2)\n* Vascular Disease (CTCAE \\>2)\n* Coronary Artery Disease (CTCAE \\>2)\n* Active contraindicated heath condition including:\n* Cranial Nerve Disorder (CTCAE \\>2)\n* Neuropathy (Cranial Nerves) (CTCAE \\>2)\n* Neuralgia (Cranial Nerves) (CTCAE \\>2)\n* Overt Cerebrovascular Accident (CTCAE \\>2)\n* Seizures (Any in most recent 1 year\n* Currently enrolled or participating in any other neurostimulation or neuromodulation ancillary research studies","ALL","20 Years","50 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"NA","This pilot study will assess the usefulness and potential effectiveness of using transcutaneous auricular vagus nerve stimulation (tVNS) for treating insomnia in adult survivors of childhood acute lymphoblastic leukemia (ALL). Participants will be randomized to receive either active (verum) or inactive (sham) nightly stimulation using a non-invasive earbud device over two time periods: 2 weeks and 8 weeks. The study will assess adherence to the intervention and estimate its effects on sleep quality, stress, and neurocognitive function.\n\nPrimary Objective:\n\nAim 1: To determine a) short-term and b) long-term feasibility of tVNS in terms of participation in ALL Survivors with moderate to severe insomnia.\n\nAim 2: To estimate the effect size of tVNS on sleep quality, stress, and neurocognitive outcomes in ALL survivors with insomnia.\n\nExploratory Objectives\n\nAim 1: To investigate the onset of tVNS effect via actigraphy measures over the intervention epoch.\n\nAim 2: To estimate the effect size of genetic variants on sleep quality within verum tVNS.",[27,28,29],"Survivor of Childhood Cancer","Insomnia","Acute Lymphoblastic Leukemia (ALL)","RECRUITING","2026-06-15",{"date":33,"type":34},"2026-06-17","ACTUAL",{"date":36,"type":34},"2026-03-31",{"date":38,"type":21},"2029-12",{"name":40,"class":41},"St. Jude Children's Research Hospital","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100642229","phase-1-first-in-human-study-of-a-new-treatment-4a10-for-patients-with-relapsed-or-hard-to-treat-acute-lymphoblastic-leukemia-or-lymphoblastic-lymphoma-focused-on-safety-and-how-the-drug-behaves-in-the-body-and-early-signs-of-effect-100642229","NCT07586618","First-in-human Study of a New Treatment (4A10) for Patients With Relapsed or Hard-to-treat Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma, Focused on Safety and How the Drug Behaves in the Body and Early Signs of Effect.","A First in Human, Phase 1, Open-Label Study on the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of 4A10 Monotherapy In Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma","ALT-101","Key Inclusion Criteria:\n\n1. Confirmed diagnosis of T\u002FB-ALL or T\u002FB-LL\n2. Relapsed or refractory disease without curative options\n3. Adequate organ function and performance status\n\nKey Exclusion Criteria:\n\n1. Patients with CNS3 disease\n2. Patients with DNA fragility syndromes (e.g., Fanconi, Bloom), trisomy 21 (Down Syndrome)\n3. Prior exposure to anti-CD127 therapies\n4. Uncontrolled infections","18 Years",{"count":5,"type":21},[54],"PHASE1","ALT-101 is a first-in-human Phase 1 clinical trial testing a new antibody drug called 4A10 in patients with relapsed or hard-to-treat acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma.\n\n4A10 is a targeted therapy designed to recognize and attach to a specific protein (CD127) found on leukemia cells. Once it binds, it works in two ways: it blocks growth signals that help cancer cells survive, and it helps the immune system find and destroy those cancer cells.\n\nIn this study, patients receive 4A10 through an intravenous (IV) infusion once a week. The main goal of the trial is to find out if the drug is safe, what dose can be given, and how the body processes it. Researchers will also look for early signs that the treatment may be working.\n\nThe study starts with small groups of patients receiving increasing doses to carefully monitor safety. Each patient is closely observed during the first treatment cycle (about 4-6 weeks) to watch for side effects. If the treatment is helping and is well tolerated, patients may continue treatment for up to six cycles.\n\nOverall, this study is an early step in testing a new, targeted immune-based therapy for difficult-to-treat blood cancers.",[57,58],"Lymphoblastic Lymphoma","Acute Lymphoblastic Leukemia ALL",[60,61,62],"Leukemia","Refractory","Relapsed","2026-06-09",{"date":65,"type":34},"2026-06-11",{"date":67,"type":34},"2026-06-01",{"date":69,"type":21},"2028-09",{"name":71,"class":72},"Allterum Therapeutics, Inc","INDUSTRY",4,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":86,"conditions":87,"keywords":91,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":112},"100643783","caya-cancer-prospective-cohort-study-100643783","NCT07632014","CAYA Cancer Prospective Cohort Study","Improving Cancer Outcomes for Children, Adolescents, and Young Adults: A Multicenter Prospective Cohort Study on Treatment Failure and Toxicity in Low- and Middle-Income Countries.","Inclusion Criteria:\n\nSubjects must meet all the following criteria to be included in this study:\n\n1. Age 0 to 21 years at study enrollment.\n2. Diagnosed with cancer and receiving active treatment or undergoing follow-up at the participating sites.\n\n   a. Note: Patients seen solely for consultation or diagnostic evaluations without subsequent treatment and those who have been off treatment for more than 5 years and are seen only for survivorship follow-up are not considered as meeting this criterion.\n3. Willingness to provide informed consent\u002Fassent. For minors incapable of providing assent, or individuals unable to provide consent, consent must be obtained from a legal representative and in accordance with local requirements.\n\nExclusion Criteria:\n\nSubjects meeting any of the following criteria must be excluded from this study:\n\n1\\. Any medical or psychological condition that, in the investigator's opinion, might compromise the ability of the patient to provide assent\u002Finformed consent\u002Fassent.","0 Years","21 Years",{"count":84,"type":21},6000,"OBSERVATIONAL","Cancer is a leading cause of illness and death among children, adolescents, and young adults(CAYAs), especially in low- and middle-income countries(LMICs), where access to timely diagnosis and treatment is often limited. As a result, patients in these settings may experience higher rates of treatment complications, interruptions, and poorer outcomes compared with those in high-income countries (HICs).\n\nThis is a prospective, multicenter observational study that will follow children, adolescents, and young adults(CAYAs) with cancer who are receiving routine care at participating hospitals in low - and middle - income countries(LMICs). The study does not involve experimental treatments or changes to standard medical care. Information will be collected from medical records and from questionnaires that address access to care and social factors affecting treatment.\n\nBy describing treatment outcomes and the challenges patients and families face during cancer care, this study aims to provide data that can help inform future efforts to improve access to care and cancer outcomes in resource-limited settings.",[88,89,90,29],"Cancer","Pediatric Cancer","Lymphoblastic Lymphoma (LBL)",[92,93,94,95,96,97,98,99,100,101,102],"Children, Adolescents, and Young Adults (CAYA)","Low- and middle-income countries (LMIC)","Observational Study","Cancer Outcomes","Treatment-Related Toxicity","Treatment Failure","Treatment Abandonment","Diagnostic Delay","Socioeconomic Factors","High-income countries (HICs)","Central Nervous System(CNS)","2026-06-03",{"date":105,"type":34},"2026-06-08",{"date":107,"type":34},"2025-11-11",{"date":109,"type":21},"2032-11-11",{"name":111,"class":41},"Resonance, Inc.",3,{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":150},"100159702","a-multicenter-access-and-distribution-protocol-for-unlicensed-cryopreserved-cord-blood-units-cbus-100159702","NCT01351545","A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)","A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs) for Transplantation in Pediatric and Adult Patients With Hematologic Malignancies and Other Indications","Inclusion Criteria:\n\n* Disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment\n* Signed informed consent (and signed assent, if applicable) obtained prior to study enrollment\n* Pediatric and adult patients of any age\n\nExclusion Criteria:\n\n* Patients who are receiving only licensed CBUs\n* Cord blood transplant recipients at international transplant centers\n* Patients who are enrolled on another IND protocol to access the unlicensed CBU(s)\n* Patients whose selected unlicensed CBU(s) will be more than minimally manipulated",{"count":121,"type":21},99999,"This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications.",[124,125,126,127,128,29,129,130,131,132,133,134,135,136,137,138,139],"Hematologic Malignancies","Inherited Disorders of Metabolism","Inherited Abnormalities of Platelets","Histiocytic Disorders","Acute Myelogenous Leukemia (AML or ANLL)","Other Acute Leukemia","Chronic Myelogenous Leukemia (CML)","Myelodysplastic (MDS) \u002F Myeloproliferative (MPN) Diseases","Other Leukemia","Hodgkin Lymphoma","Non-hodgkin Lymphoma","Multiple Myeloma\u002F Plasma Cell Disorder (PCD)","Inherited Abnormalities of Erythrocyte Differentiation or Function","Disorders of the Immune System","Autoimmune Diseases","Severe Aplastic Anemia","2026-06-02",{"date":142,"type":34},"2026-06-04",{"date":144,"type":4},"2011-10",{"date":146,"type":21},"2041-10",{"name":148,"class":149},"Center for International Blood and Marrow Transplant Research","NETWORK",142,{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":158,"enrollmentInfo":159,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":161,"conditions":162,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":42},"100467423","bio-car-t-bs-study-100467423","NCT05366569","Bio-CAR-T BS Study","Bio-CAR-T Study on Pre and Post-infusion CAR-T Cell Therapy","Inclusion Criteria:\n\n* Patients with B-cell-ALL (≤ 25 years) or patients with DLBCL (18-70 years) or patients with PMBCL (18-70 years) who were relapsed\u002Frefractory after two lines of treatments;\n* Adequate performance status (0 or 1);\n* Adequate organ function;\n* No active or uncontrolled infections;\n* No thrombo-embolisms within the last 6 months;\n* Absence of clinically relevant co-morbidities (e.g., select cardiovascular, neurologic, or immune disorders with organ dysfunction or requiring immunosuppressive treatment in the last 24 months);\n* Life expectancy of at least 3 months.\n\nExclusion Criteria:\n\n* Patients with B-cell-ALL \\> 25 years\n* Patients with DLBCL \\\u003C18 or \\>70 years\n* Patients with PMBCL \\\u003C18 or \\>70 years\n* Performance status \\> 1;\n* Active or uncontrolled infections;\n* Thrombo-embolisms within the last 6 months;\n* Presence of clinically relevant co-morbidities (e.g., select cardiovascular, neurologic, or immune disorders with organ dysfunction or requiring immunosuppressive treatment in the last 24 months);\n* Life expectancy \\\u003C 3 months.","70 Years",{"count":160,"type":21},45,"The aim of this Study is the evaluation of post-infusion CAR-T (Chimeric Antigen Receptor T Cell) expansion and persistence in patients with DLBCL, PMBCL and ALL undergoing CAR-T therapy; and the feasibility and efficacy of the treatment in the real life practice.",[163,164,29],"Diffuse Large B Cell Lymphoma (DLBCL)","Primary Mediastinal Large B-cell Lymphoma (PMBCL)","2026-04-27",{"date":167,"type":34},"2026-04-30",{"date":169,"type":34},"2022-04-26",{"date":171,"type":21},"2026-12-31",{"name":173,"class":41},"Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia",{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":182,"sex":16,"minAge":183,"maxAge":184,"enrollmentInfo":185,"targetDuration":4,"studyType":22,"phases":187,"briefSummary":188,"conditions":189,"keywords":190,"overallStatus":192,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":197,"leadSponsor":199,"locationsCount":201},"100633633","role-of-t-lymphocytes-in-hypersensitivity-reactions-to-asparaginase-in-patients-treated-for-acute-lymphoblastic-leukemia-100633633","NCT07529223","Role of T Lymphocytes in Hypersensitivity Reactions to Asparaginase in Patients Treated for Acute Lymphoblastic Leukemia.","Role of T Lymphocytes in Hypersensitivity Reactions to Asparaginase in Patients Treated for Acute Lymphoblastic Leukemia. ASTRA - Asparaginase T Cell Response Analysis","ASTRA","Inclusion Criteria:\n\n* Confirmed diagnosis of B- or T-lineage acute lymphoblastic leukemia (ALL) according to current morphological, immunophenotypic, and molecular criteria.\n* Treatment according to a standard therapeutic protocol including administration of asparaginase (PEG-asparaginase or native E. coli asparaginase).\n* Age ≥ 1 year.\n* Inclusion prior to the consolidation phase (sampling scheduled between induction and consolidation).\n\nExclusion Criteria:\n\n* Prior hematopoietic stem cell transplantation (HSCT).\n* Trisomy 21 (Down syndrome), due to distinct immunological features and potentially different tolerance to asparaginase.\n* Emergency situation or clinical context not allowing appropriate patient information and informed consent.",true,"1 Year","99 Years",{"count":186,"type":21},20,[24],"Acute lymphoblastic leukemia is a type of blood cancer that primarily affects children. Fortunately, current treatments are highly effective. One of the key drugs used is asparaginase, which works by depriving leukemic cells of a substance that is essential for their survival.\n\nHowever, asparaginase can also cause adverse effects, including severe allergic reactions in some patients. These reactions may be related to specific genetic factors and\u002For individual differences in immune responses.\n\nThe aim of this research project is to better understand why certain patients develop poor tolerance to asparaginase. To achieve this, the investigators plan to collect blood cells from patients during treatment and then re-expose these cells to the drug in the laboratory. the investigators will assess whether specific immune cells-particularly T lymphocytes-become abnormally activated, which could help explain hypersensitivity reactions.\n\nUltimately, our goal is to develop a biological assay capable of predicting which patients are at increased risk of reacting adversely to asparaginase, so that they can be offered a more tailored and safer treatment strategy.",[58],[191],"Asparaginase","NOT_YET_RECRUITING","2026-04-13",{"date":195,"type":34},"2026-04-14",{"date":167,"type":21},{"date":198,"type":21},"2027-04-30",{"name":200,"class":41},"Centre Hospitalier Universitaire de Nice",2,{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":182,"sex":16,"minAge":4,"maxAge":51,"enrollmentInfo":210,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":212,"conditions":213,"keywords":214,"overallStatus":192,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":4},"100630115","study-of-cell-free-dna-in-children-and-adolescents-with-acute-lymphoblastic-leukemia-100630115","NCT07483476","Study of Cell-free DNA in Children and Adolescents With Acute Lymphoblastic Leukemia","Etude de l'ADN Libre Circulant Dans Les leucémies Aigues Lymphoblastiques de l'Enfant et de l'Adolescent","CIRCALL","Inclusion Criteria:\n\nALL population\n\n* Age \\\u003C 18 years\n* Newly diagnosed B-cell or T-cell acute lymphoblastic leukemia\n* Absence of BCR::ABL1 rearrangement\n* For infants (\\\u003C12 months), absence of KMT2A rearrangement\n* Inclusion before initiation of corticosteroid therapy or chemotherapy\n* Written informed consent from legal guardians\n* Affiliation to a national health insurance system Control population\n* Age \\\u003C 18 years\n* Undergoing blood sampling for HLA typing in the context of bone marrow donor evaluation\n* Sibling of a patient with leukemia\n* Written informed consent from legal guardians\n* Affiliation to a national health insurance system\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding patients\n* Patients not affiliated with a health insurance system",{"count":211,"type":21},205,"Minimal residual disease (MRD) monitoring is a key prognostic factor in pediatric acute lymphoblastic leukemia (ALL). Currently, MRD assessment relies mainly on cellular DNA obtained from bone marrow aspirates. Although highly informative, this approach has limitations, including the need for invasive procedures and the fact that it reflects only the bone marrow compartment.\n\nTumor cells release fragments of genomic DNA into the bloodstream, known as circulating cell-free DNA (cfDNA). In solid tumors, cfDNA analysis has emerged as a valuable non-invasive biomarker for disease monitoring and treatment response. Recent studies have shown that cfDNA is detectable in pediatric ALL.\n\nThis study aims to investigate whether plasma cfDNA analysis could represent an alternative or complementary approach to bone marrow-based MRD assessment. cfDNA may better reflect the global tumor burden across the entire body and allow more frequent longitudinal monitoring during treatment.\n\nThe primary objective is to assess the correlation between MRD measured in plasma cfDNA and MRD measured in bone marrow cellular DNA at two key timepoints of treatment: the end of induction (Day 29) and the end of consolidation (Day 71-78).\n\nSecondary objectives include evaluating the correlation between peripheral blood cellular DNA and bone marrow MRD, describing clonal evolution using cfDNA throughout treatment and follow-up, exploring the concordance of genomic alterations detected in cfDNA and other biological compartments, assessing the prognostic value of cfDNA MRD for relapse risk and event-free survival, and characterizing cfDNA fragmentome and methylome signatures in patients compared with healthy controls.\n\nThe study will include children and adolescents with newly diagnosed ALL treated at two AP-HP pediatric hematology centers, as well as a control cohort of healthy children undergoing HLA typing for sibling stem cell transplant.",[58],[215,216,217,218,219,220,221],"Pediatric acute lymphoblastic leukemia","Minimal residual disease","Cell-free DNA","Liquid biopsy","Fragmentomics","Methylome","Clonal evolution","2026-03-16",{"date":224,"type":34},"2026-03-19",{"date":226,"type":21},"2026-04-01",{"date":228,"type":21},"2034-04-01",{"name":230,"class":41},"Assistance Publique - Hôpitaux de Paris",{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":238,"enrollmentInfo":239,"targetDuration":4,"studyType":22,"phases":241,"briefSummary":243,"conditions":244,"keywords":245,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":254},"100331048","phase-2-international-study-for-treatment-of-high-risk-childhood-relapsed-all-2010-100331048","NCT03590171","International Study for Treatment of High Risk Childhood Relapsed ALL 2010","International Study for Treatment of High Risk Childhood Relapsed ALL 2010 A Randomized Phase II Study Conducted by the Resistant Disease Committee of the International Berlin, Frankfurt, Münster (BFM) Study Group","Inclusion Criteria:\n\n* Morphologically confirmed diagnosis of 1st relapsed precursor B-cell or T-cell ALL\n* Children less than 18 years of age at date of inclusion into the study\n* Meeting HR criteria any BM relapse, early\u002Fvery early isolated BM relapse, very early isolated\u002Fcombined extramedullary relapse)\n* Patient enrolled in a participating centre\n* Written informed consent\n* Start of treatment falling into the study period\n* No participation in other clinical trials 30 day prior to study enrolment that interfere with this protocol, except trials for primary ALL\n\nExclusion Criteria:\n\n* Breakpoint cluster region-Abelson (BCR-ABL)\u002F t(9;22) positive ALL\n* Pregnancy or positive pregnancy test (urine sample positive for β-humane choriongonadotropin (HCG) \\> 10 U\u002Fl)\n* Sexually active adolescents not willing to use highly effective contraceptive method (pearl index \\\u003C1) until 12 months after end of anti-leukemic therapy\n* Breast feeding\n* Relapse post allogeneic stem-cell transplantation\n* Neuropathy \\> II°\n* The whole protocol or essential parts are declined either by patient himself\u002Fherself or the respective legal guardian\n* Objection to the study participation by a minor patient, able to object\n* Any patient being dependent on the investigator\n* No consent is given for saving and propagation of pseudonymized medical data for study reasons\n* Severe concomitant disease that does not allow treatment according to the protocol at the investigator's discretion (e.g. malformation syndromes, cardiac malformations, metabolic disorders)\n* Subjects unwilling or unable to comply with the study procedures\n* Subjects who are legally detained in an official institute","17 Years",{"count":240,"type":21},250,[242],"PHASE2","The main goal of this study is to improve the outcome of children and adolescents with acute lymphoblastic leukemia with high risk first relapse by optimization of treatment strategies within a large international trial and the integration of new agents.",[29],[16],{"date":247,"type":34},"2026-03-17",{"date":249,"type":34},"2017-09-01",{"date":251,"type":21},"2027-12-31",{"name":253,"class":41},"Charite University, Berlin, Germany",15,{"id":256,"slug":257,"hasResults":11,"nctId":258,"briefTitle":259,"officialTitle":259,"acronym":4,"eligibilityCriteria":260,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":261,"phases":4,"briefSummary":262,"conditions":263,"keywords":270,"overallStatus":277,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":281,"locationsCount":4},"100295215","expanded-access-to-venetoclax-100295215","NCT03123029","Expanded Access to Venetoclax","Exclusion Criteria:\n\n* There are other suitable treatment options.\n* The participant qualifies for ongoing clinical trials.","EXPANDED_ACCESS","This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to Venetoclax prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.",[264,265,266,267,29,268,269],"Chronic Lymphocytic Leukemia (CLL)","Multiple Myeloma","Acute Myeloid Leukemia (AML)","Non-Hodgkin's Lymphoma","Amyloidosis","Plasma Cell Leukemia",[271,272,273,274,275,276],"Expanded Access","Pre-approval Access","Compassionate Use","Special Access Program","Named Patient Basis","Special Access Scheme","AVAILABLE","2026-01-29",{"date":280,"type":34},"2026-01-30",{"name":282,"class":72},"AbbVie",{"id":284,"slug":285,"hasResults":11,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":289,"eligibilityCriteria":290,"healthyVolunteers":11,"sex":16,"minAge":291,"maxAge":292,"enrollmentInfo":293,"targetDuration":4,"studyType":22,"phases":295,"briefSummary":296,"conditions":297,"keywords":298,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":42},"100618093","childrens-laughter-and-fun-yoga-as-adjunctive-pain-relief-following-chemotherapy-100618093","NCT07327138","Children's Laughter and Fun Yoga as Adjunctive Pain Relief Following Chemotherapy.","A Multi-center, Assessor-blinded, Randomized, Parallel Group, Superiority Trial Evaluating the Efficacy of Home-based Laughter and Fun Yoga as an Adjunct for Pain Reduction in Pediatric Oncology Patients Receiving Chemotherapy.","CLAP","Inclusion Criteria:\n\n* Children aged 2-10 years.\n* Medically diagnosed with acute lymphoblastic leukemia (ALL) and currently receiving chemotherapy that includes dexamethasone pulses during the maintenance phase.\n* Clinically stable and able to participate in gentle, low-intensity yoga movements as determined by the treating physician.\n* At least one parent or legal guardian willing and able to supervise and participate in the home-based intervention sessions.\n* Written informed consent from parent\u002Flegal guardian, with age-appropriate assent from the child.\n\nExclusion Criteria:\n\n* Recent major surgery (within the past 2 weeks) that may limit safe participation in gentle activity.\n* Severe uncontrolled medical conditions (unstable vital signs, decompensated cardiac or respiratory disease, uncontrolled epilepsy) that may place the child at risk during light movement or laughter.\n* Severe visual, hearing, or cognitive impairment preventing engagement with video-based instructions and exercises.\n* Physical limitations or musculoskeletal injuries that prevent participation in the intervention.\n* Any other condition that, in the judgment of the treating physician, would interfere with safe participation or adherence.\n* Currently enrolled in another interventional clinical trial for pain management.","2 Years","10 Years",{"count":294,"type":21},60,[24],"The goal of this clinical trial is to learn if a home-based program that combines laughter and fun yoga can help lower pain in children receiving chemotherapy. The study focuses on children with acute lymphoblastic leukemia who experience pain during treatment with chemotherapy and steroids.\n\nThe main questions this study aims to answer are:\n\n1. Does adding laughter and fun yoga to usual care lower pain levels in children receiving chemotherapy?\n2. Does this program reduce the need for strong pain medicines, such as opioids?\n3. Does the program help improve mood, anxiety, and sleep during treatment?\n\nResearchers will compare children who receive laughter and fun yoga plus usual care with children who receive usual care alone to see if the program works.\n\nParticipants will:\n\n1. Be randomly assigned to either the laughter and fun yoga group or the usual care group\n2. Take part in the study during a 6-day period after receiving their chemotherapy treatment\n3. Have their pain measured once each day using a child-friendly pain scale\n4. Have parents answer short questions about pain medicine use, mood, anxiety, and sleep\n\nThe laughter and fun yoga activities are gentle, safe, and designed to be done at home with the help of a parent. All participants will continue to receive their regular medical care throughout the study.",[58],[299,300,301,302,303,304,305,306,307,308,309],"Acute Lymphoblastic Leukemia","Chemotherapy","Steroids","Pediatric Oncology","Pain Management","Cancer-related Pain","Laughter Therapy","Yoga Therapy","Non-pharmacological Intervention","Home-based Intervention","Supportive Cancer Care","2025-12-25",{"date":312,"type":34},"2026-01-08",{"date":314,"type":34},"2025-10-15",{"date":316,"type":21},"2026-12",{"name":318,"class":41},"Bahaa Bou Dargham",{"id":320,"slug":321,"hasResults":11,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":4,"eligibilityCriteria":325,"healthyVolunteers":11,"sex":16,"minAge":326,"maxAge":238,"enrollmentInfo":327,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":329,"conditions":330,"keywords":331,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":112},"100618077","tracjectories-and-predictors-of-chemotherapy-induced-peripheral-neuropathy-in-children-with-acute-lymphoblastic-leukemia-100618077","NCT07326930","Tracjectories and Predictors of Chemotherapy Induced Peripheral Neuropathy in Children With Acute Lymphoblastic Leukemia","Tracjectories and Predictors of Chemotherapy Induced Peripheral Neuropathy in Children With Acute Lymphoblastic Leukemia: A Perspective Longitudinal Study","Inclusion Criteria:\n\n* diagnosed with acute lymphoblastic leukemia\n* aged from 8 to 17 years\n* will receive vincristine according the Chinese Children's Cancer Group Acute Lymphoblastic Leukemia-2020 Project (CCCG-ALL-2020)\n* conscious with sufficient cognitive abilities to understand and express their physical state and psychological feelings accurately\n* written informed assent is obtained from the children and their parents for their participation in the study\n\nExclusion Criteria:\n\n* participating other experimental trials, such as electrical stimulation, exercise therapy may improve CIPN symptoms.\n* with severe complications, including but not limited to significant heart, brain, or lung function failure.\n* had peripheral neuropathy symptoms caused by other diseases like genetic diseases, spinal cord injury.\n* had neuromuscular diseases (e.g., traumatic brain injury and cerebral palsy).\n* had central nervous system cancer or secondary cancer.\n* had multiple treatment like radiotherapy.","8 Years",{"count":328,"type":21},173,"The goal of this study is to explore the trajectory patterns of chemotherapy induced peripheral neuropathy over the course of chemotherapy and identify predictors of distinct trajectories in children with acute lymphoblastic leukemia. A perspective longitudinal study design is utilized. Chemotherapy induced peripheral neuropathy was assessed at one week after the first use of Vincristine (VCR) (T1), one week after the second use of VCR (T2), one week after the third use of VCR (T3), one week after the fourth use of VCR (T4), two weeks after T4 (T5), two weeks after T5 (T6), two weeks after T5 (T7). Patients' demographic and clinical characteristics, physical symptoms, nutrition status, psychological distress, sleep quality, physical activity, perceived social support and coping strategy are obtained at baseline.",[58],[332,333,334,335,336],"Chemotherapy induced peripheral neuropathy","tracjectory","predictor","children","acute lymphoblastic leukemia","2025-12-24",{"date":312,"type":34},{"date":340,"type":34},"2025-06-02",{"date":342,"type":21},"2026-01-07",{"name":344,"class":41},"The Hong Kong Polytechnic University",{"id":346,"slug":347,"hasResults":11,"nctId":348,"briefTitle":349,"officialTitle":349,"acronym":350,"eligibilityCriteria":351,"healthyVolunteers":11,"sex":16,"minAge":352,"maxAge":353,"enrollmentInfo":354,"targetDuration":4,"studyType":22,"phases":356,"briefSummary":358,"conditions":359,"keywords":4,"overallStatus":192,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":363,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":371},"100615846","phase-2-framework-for-optimizing-refining-and-unifying-management-of-hsct-in-pediatric-all-100615846","NCT07297914","Framework for Optimizing, Refining, and Unifying Management of HSCT in Pediatric ALL","FORUM2","Inclusion criteria applicable to all substudies\n\n* Male and female patients with allogenic transplant indication for ALL, as determined by national frontline protocols\n* Age ≥3 months to ≤25 years at the time of HSCT.\n* Patients must be in complete remission (with \\\u003C5% blasts and absence of leukemia cells in extramedullary sites) prior to undergoing HSCT.\n* Selected donor must be either a matched donor (matched donor category includes 9\u002F10 identical siblings and 10\u002F10 or 9\u002F10 HLA-matched unrelated donors) or a mismatched family donor (≤8\u002F10 HLA match). Either bone marrow or peripheral blood stem cell grafts are permitted. Cord blood is permitted, as well, provided that the unit is at least 6\u002F8 HLA matched and with a cryopreserved cellularity of at least 3x107 nucleated cells\u002FKg recipient body weight.\n* Female patients of childbearing potential must have a negative pregnancy test at screening, and all patients must agree to adhere to effective contraception during the study period.\n* Written study informed consent and\u002For assent from the patient and\u002For the parent, or guardian\n\nExclusion criteria applicable to all substudies\n\n* Patients \\\u003C 3 months and \\> 25 years of age at the time of HSCT.\n* Patients not in complete morphological remission at the time of enrollment.\n* Patients with an initial diagnosis of Non-Hodgkin Lymphoma (NHL).\n* Patients with ALL as a secondary malignancy.\n* Patients with a history of previous autologous or allogeneic HSCT (prior allogeneic transplantation is permitted for subjects receiving post-transplant interventions, such as those enrolled in the R2 and P1 substudies, provided that this is their first allogeneic HSCT).\n* Female patients who are pregnant or breast feeding.\n* Fertile male or female patients of childbearing potential who do not agree to abstinence or, if sexually active, do not agree to the use of contraception.\n* Active clinically uncontrolled bacterial, fungal, parasitic, or viral infection. Infections are considered controlled if appropriate therapy has been instituted and, at the time of screening, no physical or radiographic signs of infection progression are present.\n* Active HBV or HCV infection that requires treatment, or at risk for HBV reactivation (e.g. positive HBsAg). Subjects with negative HbsAg and positive total HB core antibody may be included if HBV DNA is undetectable at the time of screening. Subjects who are positive for HCV antibody are eligible only if polymerase chain reaction test is negative for HCV RNA. Subjects whose immune status is unknown or uncertain must have results confirming immune status before enrollment. Prior serology results are acceptable for determining eligibility.\n* Known human immunodeficiency virus infection (HIV).\n* Significant respiratory disease including patients who are on mechanical ventilation or who have resting O2 saturation \\\u003C90% by pulse-oximetry on room-air.\n* Presence of severely impaired renal function (confirmed within 72 hours prior to study treatment start) defined by:\n* Glomerular Filtration Rate (GFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m2 using estimated creatinine clearance calculated by updated bedside Schwartz equation or Cockcroft Gault equation OR\n* Renal dialysis requirement\n* Clinically significant or uncontrolled cardiac disease including any of the following:\n* Uncontrolled hypertension\n* New York Heart Association Class III or IV congestive heart failure\n* Clinically significant cardiac arrhythmias\n* Severe hepatic insufficiency, defined by any of the following:\n* Child-Pugh Class C liver disease\n* AST (aspartate aminotransferase) or ALT (alanine aminotransferase) levels \\> 5 times the upper limit of normal (ULN), unless attributable to GvHD\n* Total bilirubin \\> 3.0 mg\u002FdL, unless attributable to GvHD\n* INR (International Normalized Ratio) ≥ 1.7\n* Clinical evidence of hepatic encephalopathy or ascites\n* Presence of severe concomitant constitutional disease that precludes treatment as per protocol, based on the investigator's judgment. Examples include but are not limited to: Down syndrome with severe comorbidities, significant cardiac malformations, and metabolic disorders affecting treatment feasibility.\n* Underlying or current medical or psychiatric condition that, in the opinion of the Investigator, would interfere participation in the study, pose a significant risk to the patient or interfere with interpretation of study data.\n* Karnofsky or Lansky performance score \\\u003C50%, indicating significant functional impairment.\n* Patients who are unwilling or unable to comply with study procedures, including follow-up requirements and treatment schedules.","3 Months","25 Years",{"count":355,"type":21},1000,[242,357],"PHASE3","Current therapeutic strategies for high-risk or relapsed ALL patients often involve intensive treatments, including allogeneic hematopoietic stem cell transplantation (HSCT). HSCT remains a cornerstone of therapy, offering curative potential; however, it is associated with considerable risks, including non-relapse mortality (NRM), significant morbidity, and long-term complications that continue to be major concerns.\n\nIn response to these challenges, the FORUM consortium has made substantial progress in improving outcomes for children with ALL undergoing HSCT. The consortium focuses on reducing life-threatening and lifelong complications, ultimately aiming to enhance quality of life for these high-risk patients. Building on the robust evidence generated by FORUM1, the FORUM2 study has been designed to further optimize the role of HSCT in ALL across all age groups and donor settings within a harmonized and internationally coordinated framework.\n\nThe FORUM2 study introduces a master protocol structure that encompasses multiple hypothesis-driven substudies, each addressing a specific determinant of HSCT outcomes. This design enables simultaneous or sequential evaluation of novel strategies while ensuring uniform governance, endpoint definitions, and data-quality standards. The overarching objective is to refine the role of HSCT in ALL by reducing treatment-related toxicity while preserving the essential graft-versus-leukemia effect.",[29,360,361],"Stem Cell Transplant","Graft -Versus-host-disease","2025-12-17",{"date":364,"type":34},"2025-12-22",{"date":366,"type":21},"2026-01-15",{"date":368,"type":21},"2032-12-01",{"name":370,"class":41},"Bambino Gesù Hospital and Research Institute",9,{"id":373,"slug":374,"hasResults":11,"nctId":375,"briefTitle":376,"officialTitle":377,"acronym":4,"eligibilityCriteria":378,"healthyVolunteers":11,"sex":16,"minAge":81,"maxAge":82,"enrollmentInfo":379,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":381,"conditions":382,"keywords":386,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":405},"100611871","caya-cancer-retrospective-cohort-study-100611871","NCT07246213","CAYA Cancer Retrospective Cohort Study","Improving Cancer Outcomes for Children, Adolescents, and Young Adults: A Multicenter Retrospective Cohort Study on Treatment Failure and Toxicity in Low- and Middle-Income Countries","Inclusion Criteria:\n\nSubjects must meet all the following criteria to be included in this registry:\n\n1. Participants must be willing and able to provide informed consent prior to enrollment in the registry.\n\n   1. For minors or individuals unable to provide informed consent, assent must be obtained along with consent from a legal guardian.\n   2. Note: Exemption applies to this criterion when waiver of informed consent\u002Fassent is granted by Institutional Review Board(IRB)\u002FIndependent Ethics Committee(IEC)\u002FCompetent Authorities(CAs).\n2. A confirmed diagnosis of any type of cancer within the 15 years prior to the site's activation date.\n3. Age 0 to 21 years at the time of diagnosis.\n4. Received substantial anti-cancer treatment at the participating center, including but not limited to:\n\n   1. Chemotherapy\n   2. Surgery\n   3. Radiation therapy\n   4. Immunotherapy\n5. Medical records are available and accessible for review\n\nExclusion Criteria:\n\n* Subjects meeting any of the following criteria will be excluded from this registry:\n\n  1. Patients who only visited the participating center for:\n\n     1. Consultation without subsequent primary anti-cancer treatment at the participating center\n     2. Pathology, radiology, or other diagnostic evaluations without treatment",{"count":380,"type":21},18000,"Despite advances in cancer treatment, significant disparities in outcomes persist between high-income countries (HICs) and low-and middle-income countries (LMICs). Around 80% of children with cancer live in LMICs, where they face challenges such as delayed diagnosis, misdiagnosis, comorbidities, distance to treatment, financial barriers, and limited access to risk-adapted therapies.\n\nAcute lymphoblastic leukemia(ALL)\u002Flymphoblastic lymphoma(LBL), for example, is one of the greatest success stories in pediatric oncology, however, such improvements are not evenly distributed worldwide, and the outcomes for leukemia patients are poorer in LMICs compared to HICs, primarily due to reduced access to quality healthcare.\n\nThis study aims to assess cancer treatment outcomes in LMICs, focusing on acute lymphoblastic leukemia\u002Flymphoblastic lymphoma. The findings will inform future studies to implement evidence-based interventions that improve care quality and reduce treatment failures through targeted strategies.",[299,57,383,384,385,29,90],"Young Adult Cancer","Adolescent Cancer","Childhood Cancers",[387,388,389,390,391,392,393,394,395,396],"Cancer outcomes","Low- and Middle-Income Countries (LMICs)","Childhood cancer","Adolescent and young adult cancer (CAYA)","Treatment failure","Therapy-related toxicities","Retrospective cohort","Leukemia outcomes","Oncology disparities","High-Income Countries (HICs)","2025-12-12",{"date":399,"type":34},"2025-12-19",{"date":401,"type":34},"2025-06-04",{"date":403,"type":21},"2028-12-04",{"name":111,"class":41},5,{"id":407,"slug":408,"hasResults":11,"nctId":409,"briefTitle":410,"officialTitle":411,"acronym":4,"eligibilityCriteria":412,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":413,"enrollmentInfo":414,"targetDuration":4,"studyType":22,"phases":416,"briefSummary":417,"conditions":418,"keywords":420,"overallStatus":192,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":423,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":4},"100610438","phase-2-all-backbone-in-ayas-100610438","NCT07227584","ALL Backbone in AYAs","Treatment of Newly Diagnosed Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia in Adolescents and Young Adults (AYAs)","Inclusion Criteria:\n\n3.1.1Confirmed diagnosis of Philadelphia chromosome-negative acute lymphoblastic leukemia.\n\n* Diagnosis should be made by peripheral blood, bone marrow aspirate, bone marrow biopsy, or tissue biopsy demonstrating ≥25% involvement by lymphoblasts, with flow cytometry or immunohistochemistry confirming B-ALL or T-ALL.\n\n  o Participants with B-cell and T-cell lymphoblastic lymphoma are eligible regardless of bone marrow involvement Participants with mixed phenotype acute leukemia (MPAL) ARE eligible, if an ALL regimen is felt to be most appropriate treatment.\n* Participants with CNS leukemia ARE eligible. 3.1.2 Allowed prior therapy:\n* Corticosteroids, hydroxyurea, all-trans retinoic acid (ATRA).\n* IT chemotherapy.\n* Emergent radiation therapy or leukapheresis for life threatening complications.\n* One cycle of prior chemotherapy (i.e. an induction cycle given at another institution and participant transfers care for post-induction treatment; OR a participant does not meet eligibility prior to induction but does meet eligibility after remission induction).\n\n3.1.3 Age 18.00 - 50.99 years 3.1.4 Direct bilirubin \\\u003C1.4 mg\u002FdL (total bilirubin \\\u003C 1.4 mg\u002FdL is acceptable). 3.1.5 Willingness to use effective means of birth control. The effects of chemotherapy on the developing human fetus are unknown. For this reason and because therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of study.\n\n3.1.6 Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\nPhiladelphia chromosome-positive \u002F BCR::ABL1 fusion 3.2.2 Participants with mature B-cell (Burkitt's) ALL. Mature B-cell ALL is defined by the presence of surface immunoglobulin AND any of the following: t(8;14)(q24;q32), t(8;22), t(2;8), or c-myc-gene rearrangement by FISH, PCR or other testing. \\[FISH\u002FPCR testing for c-myc rearrangements is not required prior to study entry, but it is suggested for participants with surface immunoglobulin expression or L3 morphology\\]. 3.2.3 Participants with acute undifferentiated leukemia. 3.2.4 Participants receiving any other investigational agent for this condition.\n\n3.2.5 Uncontrolled intercurrent illness including but not limited to ongoing infection with vital sign instability (hypotension, respiratory insufficiency), life-threatening acute tumor lysis syndrome (e.g., with renal failure), symptomatic congestive heart failure, cardiac arrhythmia, intracranial or other uncontrolled bleeding. Circumstances that may significantly interfere with a participant's ability to safely comply with study procedures, such as attend scheduled study visits, adhere to treatment protocols, or complete study assessments. These include a lack of reliable transportation, unstable housing, or psychiatric illness, but reasonable attempts should be made to overcome these circumstances, including but not limited to identifying sponsor, institutional, or thirdparty financial or social support as well as psychiatric consultation for objective assessment. 3.2.6 Sexually active participants of reproductive potential who have not agreed to use an effective contraceptive method for the duration of study participation are ineligible.\n\n3.2.7 Pregnant women are excluded from this study because many of the agents used on this protocol have potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these chemotherapy agents, breastfeeding should be discontinued if the mother is enrolled.","51 Years",{"count":415,"type":21},67,[242],"The goal of this research study is to evaluate a chemotherapy regiment for the treatment of newly diagnosed Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL) in adolescents and young adults (AYAs).\n\nThe names of the study drugs involved in this study are:\n\n* blinatumomab (a type of immunotherapy drug)\n* cyclophosphamide (a type of chemotherapy drug)\n* cytarabine (a type of antineoplastic agent)\n* dexamethasone (a type of synthetic glucocorticoid)\n* doxorubicin (a type of antineoplastic agent)\n* etoposide (a type of antineoplastic agent)\n* mercaptopurine (a type of antineoplastic agent)\n* methotrexate (a type of chemotherapy drug)\n* pegaspargase (a type of antineoplastic agent)\n* vincristine (a type of antineoplastic agent)",[299,419,29,60],"Philadelphia Chromosome-Negative Lymphoblastic Leukemia",[299,421,29,60],"Philadelphia Chromosome-Negative lymphoblastic leukemia","2025-11-10",{"date":424,"type":34},"2025-11-12",{"date":426,"type":21},"2026-04",{"date":428,"type":21},"2035-07-31",{"name":430,"class":41},"Dana-Farber Cancer Institute",{"id":432,"slug":433,"hasResults":11,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":4,"eligibilityCriteria":437,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":438,"enrollmentInfo":439,"targetDuration":4,"studyType":22,"phases":441,"briefSummary":442,"conditions":443,"keywords":447,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":456,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":462,"locationsCount":42},"100507203","phase-2-cord-blood-transplant-in-adults-with-blood-cancers-100507203","NCT05884333","Cord Blood Transplant in Adults With Blood Cancers","Optimized Cord Blood Transplantation for the Treatment of High-Risk Hematologic Malignancies in Adults","Inclusion Criteria:\n\n* I. Acute myelogenous leukemia (AML):\n* Complete first remission (CR1) at high risk for relapse such as any of the following:\n\n  * Known prior diagnosis of myelodysplasia (MDS) or myeloproliferative disorder (MPD).\n  * Therapy-related AML.\n  * Presence of extramedullary leukemia at diagnosis.\n  * Requirement for 2 or more inductions to achieve CR1.\n  * Intermediate or high ELN2017 genetic risk AML.\n  * Any patient unable to tolerate consolidation chemotherapy as would have been deemed appropriate by the treating physician.\n  * Other high-risk features not defined above.\n* Complete second remission (CR2) or greater (CR2+).\n* Patients in morphologic remission with persistent cytogenetic, flow cytometric, or molecular aberrations are eligible\n\nII. Acute lymphoblastic leukemia (ALL):\n\n* Complete first remission (CR1) at high risk for relapse such as any of the following:\n\n  * Presence of any high-risk cytogenetic abnormalities such as t(9;22), t(1;19), t(4;11) or other MLL rearrangements (11q23) or other high-risk molecular abnormality.\n  * Failure to achieve MRD- complete remission after induction therapy.\n  * Persistence or recurrence of minimal residual disease on therapy.\n  * Any patient unable to tolerate consolidation and\u002For maintenance chemotherapy as would have been deemed appropriate by the treating physician.\n  * Other high-risk features not defined above.\n* Complete second remission (CR2) or greater (CR2+). Note: ALL with less than 5% blasts at time of transplant but persistent cytogenetic, flow cytometric or molecular aberrations are eligible.\n\nIII. Other acute leukemias: Acute leukemias of ambiguous lineage or mixed phenotype with less than 5% blasts. Leukemias in morphologic remission with persistent cytogenetic, flow cytometric or molecular aberrations are eligible.\n\nIV. Myelodysplastic Syndromes (MDS) and Myeloproliferative Disorders (MPD) other than myelofibrosis:\n\n* International prognostic scoring system (IPSS) risk score of INT-2 or high risk at the time of diagnosis.\n* Any IPSS risk category if life-threatening cytopenia(s) exists.\n* Any IPSS risk category with karyotype or genomic changes that indicate high risk for progression to acute myelogenous leukemia.\n* MDS\u002FMPD overlap syndromes without myelofibrosis.\n* MDS\u002F MPD patients must have less than 10% bone marrow myeloblasts and ANC \\> 0.2 (growth factor supported if necessary) at transplant work-up.\n\nV. Non-Hodgkin lymphoma (NHL) at high-risk of relapse or progression if not in remission:\n\nEligible patients with aggressive histologies (such as, but not limited to, diffuse large B-cell NHL, mantle cell NHL, and T-cell histologies) in CR by PET\u002FCT imaging.\n\no Eligible patients with indolent B-cell NHL (such as, but not limited to, follicular, small cell or marginal zone NHL) will have 2 nd or subsequent progression with PR or CR by PET\u002FCT imaging.\n\nVI. Blastic plasmacytoid dendritic cell neoplasm (BPDCN) in morphologic remission.\n\nOrgan Function and Performance Status Criteria:\n\n* Karnofsky score equal or greater than 80% (See Appendix B; inpatient Leukemia service transfers without discharge are acceptable provided patient has equivalent KPS as if were outpatient).\n* Calculated creatinine clearance \\> 70 ml\u002Fmin.\n* Bilirubin \\\u003C 1.5 mg\u002FdL (unless benign congenital hyperbilirubinemia or hemolysis).\n* ALT \\\u003C 3 x upper limit of normal (ULN).\n* Pulmonary function: Spirometry (FVC and FEV1) and corrected DLCO) \\> 60% predicted.\n* Left ventricular ejection fraction (MOD-bp)\\> 50%.\n* Albumin \\> 3.0.\n* Hematopoietic Cell Transplantation Comorbidity index (HCT-CI) ≤5.\n\nGraft criteria:\n\nTwo CB units will be selected according to current MSKCC CB unit selection algorithm. High resolution 8-allele HLA typing and recipient HLA antibody profile will be performed. Unit selection will occur based on HLA-match, total nucleated cell (TNC) and CD34+ cell dose adjusted per patient body weight. The bank of origin will also be considered. Donor specific HLA antibodies, if present, will also be taken into consideration and may influence the selection of the graft.\n\n* Each CB unit must be at least 3\u002F8 HLA-matched to the patient considering high-resolution 8-allele HLA typing. \\[Taken from the Cord Blood Summary\\]\n* Each CB unit will be required to have a cryopreserved TNC dose of at least 1.5 x 10\\^7 TNC\u002F recipient body weight (TNC\u002F kg). \\[Taken from the Cord Blood Summary\\]\n* Each CB unit will be required to have a cryopreserved CD34+ cell dose of at least 1.5 x 10\\^5 CD34+ cells\u002F recipient body weight (CD34+ cells\u002Fkg). \\[Taken from the Cord Blood Summary\\]\n* A minimum of one unit will be reserved as a backup graft. \\[Taken from the Cord Blood Summary\\]\n* Each CB unit will be required to be cryopreserved in standard cryovolume (24-27 ml\u002Fs per unit or per bag if unit in two bags) and be red blood cell depleted. \\[Taken from the Cord Blood Summary\\]\n\nExclusion Criteria:\n\n* Diagnosis of myelofibrosis or other malignancy with moderate-severe bone marrow fibrosis.\n* Patients with persistent with CNS involvement in CSF or CNS disease at time of screening\n* Prior checkpoint inhibitors\u002F blockade in the last 12 months.\n* Two prior stem cell transplants of any kind.\n* One prior autologous stem cell transplant within the preceding 12 months.\n* Prior allogeneic transplantation.\n* Prior involved field radiation therapy that would preclude safe delivery of 400cGy TBI in the opinion of Radiation Oncology.\n* Active and uncontrolled infection at time of transplantation.\n* HIV infection.\n* Seropositivity for HTLV-1.\n* Inadequate performance status\u002F organ function.\n* Pregnancy or breast feeding.\n* Patient or guardian unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, long-term follow-up, and research tests.","65 Years",{"count":440,"type":21},54,[242],"Cord blood transplants (CBT) are a standard treatment for adults with blood cancers. MSK has developed a standard (\"optimized\") practice for cord blood transplant (CBT). This optimized practice includes how patients are evaluated for transplant, the conditioning treatment (standard chemotherapy and total body irradiation therapy) given to prepare the body for transplant, the amount of stem cells transplanted, and how patients are followed during and after transplant.The purpose of this study is to collect information about participant outcomes after CBT following MSK's optimized practice. The researchers will look at outcomes of the CBT treatment such as side effects, disease relapse, GVHD, and immune system recovery after CBT treatment.",[444,29,130,445,446,267],"Acute Myelogenous Leukemia (AML)","Myelodysplastic Syndromes (MDS)","Myeloproliferative Disorder",[448,449,450,451,452,453,454],"Cord Blood Transplant","CYCLOPHOSPHAMIDE (CYTOXAN)","CYCLOSPORINE A","FLUDARABINE","MYCOPHENOLATE MOFETIL (MMF)","THIOTEPA","23-143","2025-09-05",{"date":457,"type":34},"2025-09-08",{"date":459,"type":34},"2023-05-22",{"date":461,"type":21},"2028-05-22",{"name":463,"class":41},"Memorial Sloan Kettering Cancer Center",{"id":465,"slug":466,"hasResults":11,"nctId":467,"briefTitle":468,"officialTitle":469,"acronym":470,"eligibilityCriteria":471,"healthyVolunteers":11,"sex":16,"minAge":183,"maxAge":51,"enrollmentInfo":472,"targetDuration":4,"studyType":22,"phases":474,"briefSummary":475,"conditions":476,"keywords":479,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":483,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":491},"100583878","phase-2-newly-diagnosed-low-risk-pediatric-b-cell-all-protocol-100583878","NCT06882057","Newly-diagnosed Low Risk Pediatric B-cell ALL Protocol","Chinese Children's Cancer Group-2025 Protocol for Newly Diagnosed Low Risk Childhood B-cell Acute Lymphoblastic Leukemia","CCCG-LR-B-ALL","Inclusion Criteria:\n\nMust meet all items below:\n\n1. Age older than 1 year and younger than 18 years.\n2. Diagnosis of acute lymphoblastic leukemia by bone marrow morphology.\n3. Diagnosis of B-ALL by immunophenotyping.\n4. Low risk group\n\nExclusion Criteria:\n\nShould be excluded in the presence of any item below:\n\n1. T-ALL\n2. I\u002FHR B-ALL group\n3. sIgM+\n4. Acute leukemias of ambiguous lineage diagnosed according to WHO or EGIL criteria.\n5. Philadelphia chromosome positive ALL (Ph-ALL)\n6. ALL evolved from chronic myeloid leukemia (CML).\n7. Down's syndrome, or major congenital or hereditary disease with organ dysfunction\n8. Secondary leukemia\n9. Known underlying congenital immunodeficiency or metabolic disease\n10. Congenital heart disease with cardiac insufficiency.\n11. Glucocorticoid treatment 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)",{"count":473,"type":21},3000,[242,357],"CCCG-ALL2025 LR-B-ALL plan is designed based on the CCCG-ALL2020 plan. This is a clinical trial using 14 days of blinatumomab (Blina-14) as early intensification after induction therapy and 2nd Blina-14 in consolidation therapy in all newly diagnosed provisional low-risk (LR) pediatric acute lymphoblastic leukemia (ALL) patients, regardless of measurable residual diseases (MRD) status. We will compare the efficacy of chemotherapy combined with Blina-14, comparing to CAT+ intensification or historical regimens. Patients with early remission in depth will receive chemo-light late intensification and maintenance therapy afterwards. Early complete remission in depth and maintenance reduction will be determined by next-generation sequencing (Ig-NGS MRD).",[58,477,478],"Childhood Leukemia, Acute Lymphoblastic","B Cell Acute Lymphoblastic Leukemia (B-ALL)",[480,481],"blinatumomab","chemo-light","2025-08-23",{"date":484,"type":34},"2025-08-26",{"date":486,"type":34},"2025-03-03",{"date":488,"type":21},"2033-06",{"name":490,"class":41},"Institute of Hematology & Blood Diseases Hospital, China",27,{"id":493,"slug":494,"hasResults":11,"nctId":495,"briefTitle":496,"officialTitle":496,"acronym":4,"eligibilityCriteria":497,"healthyVolunteers":182,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":498,"targetDuration":500,"studyType":85,"phases":4,"briefSummary":501,"conditions":502,"keywords":503,"overallStatus":192,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":508,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":514,"locationsCount":4},"100601641","role-of-sf3b1-mutation-in-assessment-of-acute-and-chronic-lymphatic-leukemia-100601641","NCT07113132","Role of SF3B1 Mutation in Assessment of Acute and Chronic Lymphatic Leukemia","Inclusion Criteria:\n\n* Patients with acute lymphocytic leukemia or chronic lymphocytic leukemia of both genders at any age.\n\nExclusion Criteria:\n\n* Patients with any other type of malignancies",{"count":499,"type":21},84,"6 Months","aim of the work\n\n1. To evaluate the presence of SF3B1-K700E mutation in acute lymphoblastic leukemia and chronic lymphocytic leukemia.\n2. To determine the correlation between the presence of SF3B1-K700E mutation with other laboratory findings.",[58,264],[504,505,506],"sf3b1 mutation","all","cll","2025-08-06",{"date":509,"type":34},"2025-08-08",{"date":511,"type":21},"2025-08-01",{"date":513,"type":21},"2027-07-01",{"name":515,"class":41},"Safaa Ali",{"id":517,"slug":518,"hasResults":11,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":522,"eligibilityCriteria":523,"healthyVolunteers":11,"sex":16,"minAge":292,"maxAge":82,"enrollmentInfo":524,"targetDuration":4,"studyType":22,"phases":526,"briefSummary":527,"conditions":528,"keywords":532,"overallStatus":192,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":537,"startDateStruct":539,"completionDateStruct":541,"leadSponsor":543,"locationsCount":4},"100596244","online-physical-activity-and-health-counseling-for-survivors-of-childhood-acute-lymphoblastic-leukemia-100596244","NCT07042932","Online Physical Activity and Health Counseling for Survivors of Childhood Acute Lymphoblastic Leukemia","Online Physical Activity and Health Counseling for Survivors of Childhood Acute Lymphoblastic Leukemia (OPAC-ALL)","OPAC-ALL","Inclusion Criteria:\n\n* aged 10-21 years old,\n* at least one year from ended treatment of acute lymphoplastic leukemia\n* not adhering to WHO's recommendations for physical activity (i.e., 60 minutes of daily moderate-to-vigorous intensity physical activity including two weekly sessions of strength training for children and 150 minutes of moderate-to-vigorous intensity weekly for adults),\n* followed at the pediatric oncology out-patient clinic at Copenhagen University Hospital, Rigshospitalet.\n\nExclusion Criteria:\n\n* Children with a mental disability,\n* other severe physical co-morbidity contradicting physical exercise,\n* and\u002For terminal illness",{"count":525,"type":21},82,[24],"Advances in the medical treatment of childhood acute lymphoblastic leukemia (ALL) have resulted in 5-year survival rates above 90%- however, the success is not without consequences. Childhood ALL survivors experience markedly impaired physical capacity - reducing their opportunity to engage in everyday activities including leisure activities, sports, and school - affecting their quality of life. Furthermore, Childhood ALL survivors have markedly increased risk of chronic medical conditions including cardiometabolic diseases - that can be prevented through an active lifestyle. Thus, it is imperative to develop novel interventions that can mitigate these treatment-related late-effects. In this RCT, including 82 childhood ALL survivors (10-21 years-old), we will investigate a 26-week online exercise intervention combined with access to a lifestyle physical activity webpage, and health consultations on cardiorespiratory fitness (primary outcome) markers of metabolic syndrome, and physical activity habits.\n\nWhile other pilot studies have investigated the effects of exercise for childhood ALL survivors, this study is the first RCT internationally to investigate the effects of online exercise combined with education through an app and health counselling for childhood ALL survivor. Using this approach, we are geographically able to reach every survivor in our targeted population, thereby, minimizing logistic challenges like travel distances.\n\nThis study has the potential to radically change the way physical rehabilitation is approached in childhood ALL survivors - Potentially changing the workflow of health professionals from referring only survivors with specific deficits to local physiotherapy to referring all survivors to an exercise program tailored to their needs. By improving the children's general physical capacity, we can give the children the required tools to re-enter everyday life activities, including school physical education, leisure activities, and sports earlier after treatment has ended - ultimately minimizing the social complications of treatment. This study will also answer the government´s call to digitalize 30% of rehabilitation by the 2030.",[58,529,530,531],"Childhood Cancer Survivors","Exercise","Rehabilitation Exercise",[530,533,534,535],"rehabilitation","Acute lymphoblastic leukemia","childhood cancer survivors","2025-06-25",{"date":538,"type":34},"2025-06-29",{"date":540,"type":21},"2025-07-01",{"date":542,"type":21},"2030-12-31",{"name":544,"class":41},"Rigshospitalet, Denmark",{"id":546,"slug":547,"hasResults":11,"nctId":548,"briefTitle":549,"officialTitle":550,"acronym":551,"eligibilityCriteria":552,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":438,"enrollmentInfo":553,"targetDuration":4,"studyType":22,"phases":555,"briefSummary":556,"conditions":557,"keywords":561,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":567,"lastUpdatePostDateStruct":568,"startDateStruct":570,"completionDateStruct":572,"leadSponsor":574,"locationsCount":42},"100581075","safely-delivered-targeted-high-dose-irradiation-followed-by-adoptive-immunotherapy-with-regulatory-and-conventional-t-cells-to-increase-potency-of-hematopoietic-stem-cell-transplantation-in-high-risk-acute-leukemia-100581075","NCT06845592","Safely Delivered Targeted High-dose Irradiation Followed by Adoptive Immunotherapy with Regulatory and Conventional T Cells to Increase Potency of Hematopoietic Stem Cell Transplantation in High-risk Acute Leukemia","SHARP - Safely Delivered Targeted High-dose Irradiation Followed by Adoptive Immunotherapy with Regulatory and Conventional T Cells to Increase Potency of Hematopoietic Stem Cell Transplantation in High-risk Acute Leukemia","SHARP","Inclusion Criteria:\n\n* AML patients\n\n  * Diagnosis of AML with indication to allogeneic hematopoietic cell transplantation.\n  * Diagnosis of adverse genetic risk leukemia or presence of MRD or active disease (bone marrow infiltration 5-30%) at the time of the transplant procedure.\n  * Availability of a hematopoietic stem cell donor (family or unrelated HLA-matched or HLA-haploidentical with the patient) suitable to be treated with G-CSF (10 mcg\u002Fkg\u002Fdie) for a maximum of 7 days and able to tolerate 2 or more leukaphereses.\n  * Age ≥ 18 and ≤ 65 years\n  * ECOG ≤ 2\n  * HCT-CI ≤ 4 (51,52)\n  * Absence of relevant psychiatric diseases\n  * Signature of the informed consent\n\nALL patients\n\n* Diagnosis of ALL, either T or B (Philadelphia negative) or mixed phenotype with indication to allogeneic transplant\n* Presence of MRD or active disease (bone marrow infiltration 5-30%) or patient with ≥ 2nd complete hematologic remission at the time of the transplant procedure.\n* Availability of a hematopoietic stem cell family donor (family or unrelated HLA-matched or HLA-haploidentical with the patient) suitable to be treated with G-CSF (10 mcg\u002Fkg\u002Fdie) for a maximum of 7 days and able to tolerate 2 or more leukaphereses.\n* Age ≥ 18 and ≤ 65 years\n* ECOG ≤ 2\n* HCT-CI ≤ 4\n* Absence of relevant psychiatric diseases\n* Signature of the informed consent\n\nExclusion Criteria:\n\n* AML patients\n\n  * AML in CR MRD-\n  * AML with \\> 5% peripheral blasts or bone marrow infiltration ≥ 30%\n  * Age \\\u003C 18 years or \\> 65 years\n  * ECOG \\> 2\n  * Unacceptable lung, liver, kidney, and\u002For heart function and presence of relevant psychiatric diseases according to clinical judgment\n  * Pregnancy\n  * No signature of the informed consent\n* ALL patients\n\n  * ALL with \\> 5% peripheral blasts or bone marrow infiltration ≥30%\n  * Philadelphia positive ALL\n  * Age \\\u003C 18 years or \\> 65 years\n  * ECOG \\> 2\n  * Unacceptable lung, liver, kidney, and\u002For heart function and presence of relevant psychiatric diseases according to clinical judgment\n  * Pregnancy\n  * No signature of the informed consent",{"count":554,"type":21},51,[24],"The study is a monocentric, interventional study that evaluates the efficacy of allogeneic HLA-matched or haploidentical transplantation consisting of an irradiation-based conditioning regimen coupled with donor Treg\u002FTcon adoptive immunotherapy for high-risk acute leukemia patients.",[558,58,559,560],"Acute Myeloid Leukaemia (AML)","High Risk Leukaemia","Leukaemia Relapse",[562,16,551,563,564,565,566],"AML","Total marrow\u002Flymphoid irradiation","Treg","Tcon","Relapse","2025-03-01",{"date":569,"type":34},"2025-03-04",{"date":571,"type":34},"2025-02-25",{"date":573,"type":21},"2031-01",{"name":575,"class":41},"University Of Perugia",{"id":577,"slug":578,"hasResults":11,"nctId":579,"briefTitle":580,"officialTitle":581,"acronym":582,"eligibilityCriteria":583,"healthyVolunteers":11,"sex":16,"minAge":584,"maxAge":51,"enrollmentInfo":585,"targetDuration":4,"studyType":22,"phases":587,"briefSummary":588,"conditions":589,"keywords":590,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":593,"lastUpdatePostDateStruct":594,"startDateStruct":596,"completionDateStruct":598,"leadSponsor":600,"locationsCount":601},"100574819","phase-2-newly-diagnosed-intermediatehigh-risk-pediatric-b-cell-all-protocol-100574819","NCT06764238","Newly-diagnosed Intermediate\u002FHigh Risk Pediatric B-cell ALL Protocol","Chinese Children's Cancer Group-2025 Protocol for Newly Diagnosed for Intermediate\u002FHigh Risk Childhood B-cell ALL","CCCG-I\u002FHR-ALL","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 B-ALL by immunophenotyping.\n\nExclusion Criteria:\n\n1. Low-risk ALL\n2. sIgM+\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)","1 Month",{"count":586,"type":21},1800,[242,357],"Building upon the results from the CCCG-ALL-2015, CCCG-ALL-2020 multicenter study cohort, concurrent research findings, and the latest clinical trials, the CCCG-ALL-2025 I\u002FHR-B-ALL is thus developed to further improve the event-free survival (EFS), and overall survival (OS), and quality of life (QoL) of children with intermediate- and high- risk B-cell childhood acute lymphoblastic leukaemia (I\u002FHR-B-ALL), while decreasing adverse reactions and transplantation rates. This trial primarily aims to explore:\n\n1. The efficacy of two randomized Blinatumomab application scheme on I\u002FHR-ALL as determined by MRD negatvitiy rate.\n2. The efficacy of modified mini-hyperCVD + Venetoclax in I\u002FHR-ALL cannot afford blinatumomab, in contrast to historical control as determined by MRD negatvitiy rate.",[58,477,478],[591,592],"blinatimomab","venetoclax","2025-02-04",{"date":595,"type":34},"2025-02-07",{"date":597,"type":34},"2025-01-03",{"date":599,"type":21},"2031-06",{"name":490,"class":41},26,{"id":603,"slug":604,"hasResults":11,"nctId":605,"briefTitle":606,"officialTitle":607,"acronym":4,"eligibilityCriteria":608,"healthyVolunteers":11,"sex":16,"minAge":609,"maxAge":51,"enrollmentInfo":610,"targetDuration":4,"studyType":22,"phases":612,"briefSummary":613,"conditions":614,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":615,"lastUpdatePostDateStruct":616,"startDateStruct":618,"completionDateStruct":620,"leadSponsor":622,"locationsCount":73},"100433882","bright-ideas---cin-feasibility-study-100433882","NCT04929899","Bright Ideas - CIN Feasibility Study","Improving Chemotherapy-induced Nausea Control Through Bright Ideas®-CIN Training: a Feasibility Study in Children Receiving Oral Chemotherapy","Inclusion Criteria:\n\n* Age: ≥ 4 years (PeNAT validated in patients 4 to 18 yrs)\n* newly diagnosed or recurrent disease: first diagnosis of ALL (i.e. non-relapsed) in maintenance therapy\n* English, French or Spanish-speaking with an English, French or Spanish-speaking guardian (PeNAT available in these languages)\n* without physical or cognitive impairments that preclude use of the PeNAT\n* planned to receive PO 6-mercaptopurine\n* not planned to receive IV, IM, SC or IT chemotherapy or oral or IV corticosteroids during the 7-day study period","4 Years",{"count":611,"type":21},75,[24],"In this study investigators will determine the feasibility of a future trial comparing chemotherapy-induced nausea control in children with ALL receiving oral 6-mercaptopurine who do and do not receive problem-solving skill training. This is a novel approach to controlling an important and common treatment-related symptom.",[29],"2025-01-28",{"date":617,"type":34},"2025-01-31",{"date":619,"type":34},"2022-03-01",{"date":621,"type":21},"2025-06",{"name":623,"class":41},"The Hospital for Sick Children",{"id":625,"slug":626,"hasResults":11,"nctId":627,"briefTitle":628,"officialTitle":629,"acronym":4,"eligibilityCriteria":630,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":631,"enrollmentInfo":632,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":633,"conditions":634,"keywords":636,"overallStatus":192,"whyStopped":4,"lastUpdateSubmitDate":640,"lastUpdatePostDateStruct":641,"startDateStruct":643,"completionDateStruct":645,"leadSponsor":647,"locationsCount":42},"100571541","an-extension-study-to-evaluate-the-safety-and-efficacy-of-an-anti-cd19-car-t-product-in-patients-with-b-cell-lymphoproliferative-disorders-100571541","NCT06721598","An Extension Study to Evaluate the Safety and Efficacy of an Anti-CD19 CAR-T Product in Patients with B-cell Lymphoproliferative Disorders","An Open-label, Non-interventional, Single-group Follow-up Study to Evaluate the Safety and Efficacy of an Anti-CD19 CAR-T Product in Adult Patients with Relapsed or Refractory Forms of B-cell Lymphoproliferative Disorders","Inclusion Criteria:\n\n1. Successful completion of the HemC101-01-01 study procedures.\n2. Negative pregnancy test for women of reproductive potential.\n\nExclusion Criteria:\n\n1. Uncontrolled life-threatening infection. A urinary tract infection is acceptable. Patients who received intravenous antibiotics before IMP administration or in whom intravenous antibiotics have not been discontinued 7 days before inclusion in the study. Prophylactic use of antibiotics, antiviral, or antifungal drugs is allowed.\n2. The use of therapeutic interventions prohibited by the protocol (glucocorticosteroids, allogeneic cell therapy, GVHD therapy, chemotherapy, alemtuzumab, clofarabine, cladribine, and biologics derived from mouse materials).\n3. Non-adherence to HemC101-01-01 study procedures that, in the investigator's opinion, put the patient at risk if they participate in the study and may significantly bias the assessment of study results.\n4. Any clinically relevant data that, in the investigator's opinion, affects the patient's ability to enter the study and puts the patient at risk.","71 Years",{"count":294,"type":21},"This follow-up study is designed to evaluate the long-term safety and effectiveness of a treatment called anti-CD19 CAR-T cell therapy in adults with certain B-cell blood cancers. These cancers include types that have returned after treatment or have not responded to other therapies. CAR-T cell therapy involves using a patient's own immune cells, which are modified in a lab to specifically target and destroy cancer cells with a marker called CD19. The study will look at how well patients tolerate this treatment over time, as well as its ability to keep cancer in remission or reduce its severity.\n\nPatients who have previously received CAR-T therapy in an earlier clinical trial and meet specific criteria can participate in this study. The research will include regular follow-up visits over approximately 11 months to monitor for side effects, assess cancer response, and track the activity of CAR-T cells in the body. This study does not involve additional treatments but focuses on understanding the long-term outcomes of CAR-T therapy to provide better care for patients in the future.",[635,58],"Non-Hodgkin Lymphoma, B-cell",[637,638,639],"CAR-T","B-cell lymphoma","non-Hodgkin lymphoma","2024-12-03",{"date":642,"type":34},"2024-12-06",{"date":644,"type":21},"2025-01-09",{"date":646,"type":21},"2026-09-30",{"name":648,"class":149},"National Research Center for Hematology, Russia",{"id":650,"slug":651,"hasResults":11,"nctId":652,"briefTitle":653,"officialTitle":654,"acronym":4,"eligibilityCriteria":655,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":438,"enrollmentInfo":656,"targetDuration":4,"studyType":22,"phases":657,"briefSummary":658,"conditions":659,"keywords":660,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":663,"lastUpdatePostDateStruct":664,"startDateStruct":666,"completionDateStruct":668,"leadSponsor":670,"locationsCount":42},"100562836","phase-2-autologous-hematopoietic-stem-cell-transplantation-combined-with-cd19-cart-treatment-of-adult-high-risk-acute-lymphoblastic-leukemia-100562836","NCT06608342","Autologous Hematopoietic Stem Cell Transplantation Combined With CD19-CART Treatment of Adult High-risk Acute Lymphoblastic Leukemia","Clinical Study of Autologous Hematopoietic Stem Cell Transplantation Combined With CD19-CART Treatment for Adult High-risk Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* Adult patients with high-risk acute B-lymphoblastic leukemia\n* Complete remission was achieved after induction chemotherapy, and autologous CD19-CAR-T was successfully prepared\n* Eligible for autologous hematopoietic stem cell transplantation\n* No major organ dysfunction\n\nExclusion Criteria:\n\n* Combined with malignant tumors of other organs\n* With a serious infection that is not under control\n* Syphilis, AIDS, hepatitis B, hepatitis C, any one of them positive\n* Patients who have had an allergic reaction to the drugs used in this study or similar drugs\n* Other patients deemed unsuitable for inclusion by the investigators",{"count":186,"type":21},[242],"To observe the efficacy and side effects of autologous hematopoietic stem cell transplantation combined with CD19-CART for adult acute lymphoblastic leukemia, and to evaluate the safety and efficacy of this regimen in the treatment of acute lymphoblastic leukemia.",[58],[661,662],"inaticabtagene autoleucel","auto-HSCT","2024-09-19",{"date":665,"type":34},"2024-09-23",{"date":667,"type":34},"2024-06-25",{"date":669,"type":21},"2028-05-30",{"name":490,"class":41},{"id":672,"slug":673,"hasResults":11,"nctId":674,"briefTitle":675,"officialTitle":676,"acronym":677,"eligibilityCriteria":678,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":438,"enrollmentInfo":679,"targetDuration":4,"studyType":22,"phases":681,"briefSummary":682,"conditions":683,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":686,"lastUpdatePostDateStruct":687,"startDateStruct":688,"completionDateStruct":690,"leadSponsor":691,"locationsCount":201},"100561667","phase-1-car-t-cells-in-the-treatment-of-refractory-and-relapsed-cd19-b-cell-neoplasms-100561667","NCT06593145","CAR T Cells in the Treatment of Refractory and Relapsed CD19+ B Cell Neoplasms","Application of the Autologous CAR T Cells (Tarcidomgen Kimleucel) in the Treatment of Refractory and Relapsed CD19+ B Cell Neoplasms","CARLA","Inclusion Criteria:\n\n1. Adult patients 18-65 both inclusive;\n2. Diagnosis of:\n\n   1. Refractory B-ALL (acute lymphocytic leukemia) - relapse after hematopoietic cell transplantation, second or more relapse in patients when transplantation is contraindicated)\n   2. Large B-cell lymphoma including DLBCL NOS, lymphoma with high level of malignancy, follicular lymphoma transformed to DLBCL and primary mediastinal lymphoma - refractory or relapse or after at least 2 lines of systemic treatment)\n   3. Mantle cell lymphoma (MCL) - relapsing or refractory after at least 2 lines of systemic treatment; Diagnostics of individual diagnoses (criteria for complete remission and partial responses for individual disease entities) was developed on the basis of current (July 2022) recommendations of experts of the Polish Society of Clinical Oncology\n3. Confirmed CD19 expression on malignant cells;\n4. General condition measured by ECOG (Eastern Cooperative Oncology Group) ≤ 1;\n5. Patient's weight between 40 kg - 130 kg\n6. Sufficient general condition of organs on screening visit:\n\n   1. ALT\u002FAST \\\u003C2,5 of UNL and bilirubin \\\u003C1,5 mg\u002Fdl (\\\u003C4 mg\u002Fdl for patients with Gilbert syndrome)\n   2. Ejection fraction (EF) \\>50% confirmed in ECHO with no signs of exudation in pericardium during 6 weeks before screening\n   3. Saturation of arterial blood \\>93% with no oxygen insufflation, with no significant exudation in pleural cavity\n   4. Serum creatinine clearance \\>60 ml\u002Fmin (by Cockcroft-Gault formula);\n7. Negative result for HCV, HBV, HIV, Syphilis;\n8. Negative test for pregnancy (serum or urine) in the screening visit and\u002For 7 days before leucapheresis and 7 days before lymphodepleting therapy in women in reproductive age;\n9. Assumption of at least 12 months of survival time from screening visit;\n10. Agreement to maintain sufficient method of contraception from the date of signing informed consent to 6 months after CART therapy;\n11. The last dose of SARS-CoV-2 vaccination taken at least 6 months prior to study enrollment\n12. Capable of providing written informed consent;\n13. Patients polish native language speaking or fluent in polish language\n\nExclusion Criteria:\n\n1. Any significant CNS diseases that preceded and not connected with relapse (including seizures, paresis, aphasia, stroke or CNS bleeding, severe brain trauma, dementia, Parkinson's disease, any disease affecting cerebellum, psychosis and diseases involving lack of coordination or movement);\n2. Bulky or rapidly progressing disease;\n3. Less than 3 months after allo-HSCT transplantation or DLI before screening;\n4. The need for high-dose chemotherapy less than 4 weeks before the scheduled apheresis;\n5. Concomitant presence of another malignancy and another malignancy diagnosed up to 2 years before inclusion to this trial;\n6. Patient's weight below 40 kg and above 130kg\n7. Any active bacterial, viral or fungal infection including SARS-CoV2;\n8. Latent HBV\u002FHCV\u002FHIV\u002FSyphilis infection;\n9. Any other concomitant disease which in the opinion of the investigator would be interfering with the safety of participant in the trial\n10. Allergic to penicillin, streptomycin and amphotericin B;\n11. Intolerance to cyclophosphamide or fludarabine during previous treatment with these drugs;\n12. Chronic systemic immunosuppression treatment (i.e. cyclosporin). Corticosteroids are allowed up to dexamethasone dose of 4 mg a day or equal of this dose;\n13. Systemic immunosuppression treatment of acute and\u002For chronic Graft-versus host disease (GvHD) connected to earlier allogeneic HSCT treatment;\n14. Pregnancy;\n15. Women in reproductive age as well as men (regardless of age) that do not agree to maintain effective method of contraception during the trial, lactated women can be included into the trial unless declaration of stopping breast feeding during the whole trial time;\n16. Unable to provide informed consent for this trial;\n17. Lack of actual vaccination against SARS-CoV2 by vaccine accepted to use in the EU;\n18. Patients who are not fluent in polish language;\n19. Previous use of anti-CD19 CART therapy",{"count":680,"type":21},6,[54],"One arm, open label study to assess the clinical use of Investigational Medicinal Product FCTX-CL19-1 (scientific name: Tarcidomgen Kimleucel) containing autologous anti-CD19 CAR T cells with a preliminary determination of the safety of intravenous IMP administration in patients diagnosed with refractory and relapsed CD19 + B cell neoplasms.",[29,684,685],"Mantle Cell Lymphoma (MCL)","Large B-cell Lymphoma","2024-09-12",{"date":663,"type":34},{"date":689,"type":34},"2023-05-24",{"date":621,"type":21},{"name":692,"class":72},"FamiCordTx"]