[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-lymphoblastic-leukemia-pediatric\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-lymphoblastic-leukemia-pediatric":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,40,74,103,131,166,190,211,229,254,280],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100521828","behavioral-parenting-skills-as-a-novel-target-for-improving-pediatric-medication-adherence-study-3-100521828",false,"NCT06074666","Behavioral Parenting Skills as a Novel Target for Improving Pediatric Medication Adherence: Study 3","Inclusion Criteria:\n\n* Parent of a child who is diagnosed and being treated for any type of acute lymphoblastic leukemia (ALL) at a study site.\n* Parent has primary medication responsibility.\n* Pediatric patient aged 3-9 years\n* Child on therapy that includes home-based oral anti-cancer medication, such as 6-MP.\n* Parent has verbal English or Spanish fluency.\n* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board approved written informed consent form prior to receiving any study related procedure\n\nExclusion Criteria:\n\n* Parent is unwilling or unable to follow protocol requirements","ALL","3 Years","9 Years",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23],"NA","The current study will assess the acceptability and feasibility of the CareMeds intervention with a larger sample (N = 100) across multiple sites in Buffalo, NY, and Atlanta, GA.",[26],"Acute Lymphoblastic Leukemia, Pediatric","RECRUITING","2026-04-22",{"date":30,"type":31},"2026-04-23","ACTUAL",{"date":33,"type":31},"2024-11-07",{"date":35,"type":20},"2027-10-01",{"name":37,"class":38},"Roswell Park Cancer Institute","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":15,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":52,"conditions":53,"keywords":59,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100584654","massage-impact-on-sleep-in-pediatric-oncology-100584654","NCT06892158","Massage Impact on Sleep in Pediatric Oncology","Massage Impact on Sleep in Hospitalization for Pediatric Oncology and Stem Cell Transplant Patients","Inclusion Criteria:\n\n1. Diagnosis of cancer, such as acute myeloid leukemia (AML) or relapsed acute lymphoblastic leukemia (rALL) OR admitted to receive autologous or allogeneic HSCT for any indication\n2. Expected to be an inpatient for at least 21 days\n3. Aged 12 to 21 years at enrollment.\n4. Inpatient at Children's National or Children's Hospital of Philadelphia (CHOP).\n\nExclusion Criteria:\n\n1. Cognitive impairment sufficient to preclude completing questionnaires appropriately\n2. Insufficient knowledge of English or Spanish that would prohibit completing the study instruments\n3. Previous enrollment","12 Years","21 Years",{"count":50,"type":20},70,[23],"This study aims to determine the impact of massage therapy for pediatric patients receiving intensive chemotherapy or stem cell transplant (SCT).",[54,55,56,57,26,58],"Cancer","Pediatric Cancer","Chemotherapy Effect","Acute Myeloid Leukemia","Hematopoietic Stem Cell Transplantation (HSCT)",[60,61,62,63],"Stem cell transplant (SCT)","Decreased sleep efficiency","Pediatric cancer diagnosis","Circadian activity rhythm (CAR)","2026-04-13",{"date":66,"type":31},"2026-04-15",{"date":68,"type":31},"2025-01-23",{"date":70,"type":20},"2028-07",{"name":72,"class":38},"Children's Hospital of Philadelphia",2,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":15,"minAge":47,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":73},"100601313","phase-1-a-phase-i-dose-finding-study-of-mb-cart22191-100601313","NCT07108868","A Phase I Dose Finding Study of MB-CART2219.1","A Phase I Dose Finding Study of MB-CART2219.1 Targeting CD19\u002FCD22 in Adult and Pediatric Patients With Relapsed\u002FRefractory B-cell Malignancies","Inclusion Criteria:\n\n1. For Cohort I Lymphoma, adults: Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).\n2. For Cohort II ALL, pediatrics: Subject is ≥ 12 years of age at the time of signing ICF.\n3. Patient or legal guardian understand and voluntarily sign an informed consent document prior to any study related assessments\u002Fprocedures.\n4. Able to adhere to the study visit schedule and other protocol requirements as well as agrees to continued follow up for up to 15 years as mandated by the regulatory guidelines for gene therapy trials.\n5. CD19 or CD22 expression must be detected on the malignant cells by flow cytometry or immunohistochemistry. Results of previous assessments after the last treatment with CD19 targeted therapies but preceding inclusion of the patient in this trial are acceptable, if available.\n6. Female Subject of childbearing potential and male subjects with female partner of childbearing potential is willing to use highly effective contraceptive methods during treatment until 12 months after IMP exposure.\n7. All subjects must agree to refrain from donating blood while on study drug and for 1 year after discontinuation from this study treatment.\n8. Male or female patients must have relapsed refractory (r\u002Fr) CD19 or CD22 -expressing ALL or Lymphoma\u002FCLL and meet the following disease-specific criteria.\n\n   1. Patients with r\u002Fr lymphoma with following entities according to 5th edition of the WHO Classification of Haematolymphoid Tumors after two or more systemic therapies, including one approved in label CAR-T-cell or bispecific antibody treatment option or with contraindications for such treatments:\n\n      * B-lymphoblastic lymphomas\n      * B-Chronic lymphocytic leukemia\n      * Splenic B-cell lymphoma\n      * Marginal zone lymphoma\n      * Follicular lymphoma\n      * Mantle cell lymphoma\n      * Large B-cell lymphoma\n      * Burkitt lymphoma\n      * Transformation from indolent lymphoma\n   2. Patients with r\u002Fr CLL after established and approved treatment options including therapy with BTK inhibitors have failed\n   3. Patients with lymphoma recommended for autologous or allogeneic stem cell transplant (SCT) therapy by interdisciplinary boards, but not consenting or ineligible for this treatment (including patients with refractory disease precluding allo SCT at this time, which can be included in the study as bridge to allo SCT)\n   4. Patients with lymphoma relapse after SCT, or afterCD19 or CD22 targeting therapies and with confirmed either CD19 or CD22 expression after relapse\n   5. Patients with CNS involvement by lymphoma are eligible if disease is successfully controlled at the time of inclusion\n\nExclusion Criteria:\n\n1. Subject received any of the following within the last 7 days of leukapheresis:\n\n   * Any investigational agent\n   * Immunsupressive medication\n   * Plasmapheresis\n   * Major surgery (as defined by the investigator)\n   * Radiation therapy other than local therapy for underlying malignancy\n   * Use of any systemic anti-neoplastic drug therapy or immune suppressive medication applied for graft versus-host-disease or other, including the use of high dose steroids e.g. \\>0,5 mg\u002Fkg BW methylprednisolone other than hydrocortisone replacement and other than intermittent topical, inhaled or intranasal corticosteroids which are allowed\n2. Subject has ECOG \\> 3 at screening for inclusion in the trial\n3. Subject has clinical evidence of pulmonary leukostasis, disseminated intravascular coagulation or active graft versus-host-disease\n4. History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, subarachnoid hemorrhage or other CNS bleed, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis\n5. Subject has any of the following laboratory abnormalities:\n\n   * Absolute neutrophil count (ANC) \\\u003C 500\u002FμL\n   * Absolute lymphocyte count \\\u003C 200\u002FµL at time of leukapheresis\n   * Platelet count \\\u003C 50,000 mm3 (platelet transfusion allowed)\n   * Serum Creatinine Clearance (CrCl) \\\u003C 45 mL\u002Fmin\n   * Corrected serum calcium \\> 13.5 mg\u002FdL (\\> 3.4 mmol\u002FL)\n   * Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 2.5 × upper limit of normal (ULN)\n   * Serum total bilirubin \\> 1.5 × ULN or \\> 3.0 mg\u002FdL for subjects with documented Gilbert's syndrome\n   * International ratio (INR) or partial thromboplastin time (PTT) \\> 1.5 × ULN, or history of Grade ≥ 2 hemorrhage within 30 days, or subject requires ongoing treatment with chronic, therapeutic dosing of anticoagulants (eg, warfarin, low molecular weight heparin, Factor Xa inhibitors)\n6. Patient has no adequate vascular access for leukapheresis\n7. Echocardiogram (ECHO) or multi-gated acquisition (MUGA) with left ventricular ejection fraction \\\u003C 45%\n8. Patient with a history of Class III or IV congestive heart failure (CHF) or severe nonischemic cardiomyopathy, unstable or poorly controlled angina, myocardial infarction, or ventricular arrhythmia within the previous 3 months prior to starting study treatment\n9. Inadequate pulmonary function defined as oxygen saturation (Sa02) \\\u003C 90 % on room air\n10. Subject has history of primary immunodeficiency\n11. Subject is positive for human immunodeficiency virus (HIV-1), uncontrolled hepatitis B or C or active hepatitis A\n12. Subject with ongoing (incl. controlled) infections or infestations where inclusion of the patient into the clinical trials may significantly jeopardize the health and wellbeing of the patient, as determined by the investigator.\n13. Subject with malignancy other than the underlying malignancy in this protocol, unless this disease has been controlled for ≥ 1 year and the exception of the following noninvasive malignancies:\n\n    * Basal cell carcinoma of the skin\n    * Squamous cell carcinoma of the skin\n    * Carcinoma in situ of the cervix\n    * Carcinoma in situ of the breast\n    * Incidental histologic finding of prostate cancer (T1a or T1b using the TNM \\[tumor, nodes, metastasis\\] clinical staging system) or prostate cancer that is curative\n14. Patient is a female who is pregnant, nursing, or breastfeeding, or who intends to become pregnant during participation in the study\n15. Patient with known hypersensitivity to any component of MB-CART2219.1 product, cyclophosphamide, fludarabine, and\u002For tocilizumab\n16. Patient has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study\n17. Patient has any further condition including the presence of further laboratory abnormalities, which places the subject at unacceptable risk if he\u002Fshe were to participate in the study or confounds the ability to interpret data from the study","75 Years",{"count":83,"type":20},36,[85],"PHASE1","A Phase I dose finding study of MB-CART2219.1 targeting CD19\u002FCD22 in adult and pediatric patients with relapsed\u002Frefractory B-cell malignancies",[88,89,26],"Lymphoma","CLL",[91,92,93],"MB-CART2219.1 targeting CD19\u002FCD22","CD19\u002FCD22","CAR-T cells","2025-08-04",{"date":96,"type":31},"2025-08-07",{"date":98,"type":31},"2025-06-23",{"date":100,"type":20},"2027-06",{"name":102,"class":38},"University Hospital Tuebingen",{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":15,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":21,"phases":115,"briefSummary":117,"conditions":118,"keywords":119,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":130},"100535866","phase-2-treatment-of-pediatric-very-high-risk-acute-lymphoblastic-leukemia-in-korea-100535866","NCT06257394","Treatment of Pediatric Very High-risk Acute Lymphoblastic Leukemia in Korea","Multi-center Clinical Trial for Optimal Treatment of Pediatric Very High-risk Acute Lymphoblastic Leukemia in Korea","VHR ALL","Inclusion Criteria:\n\n* Pediatric patients diagnosed with ALL between the ages of 1 and 19 years at the time of diagnosis who meet one or more of the following conditions:\n\n  * Philadelphia chromosome-positive t(9;22)(q34;q11) or\n  * Patients with failed remission who had blast \\> 5% on bone marrow test after initial remission induction therapy or\n  * Hypodiploidy (Number of chromosomes \\< 44 (less than 44)) or\n  * E2A-HLF(Hepatic Leukemia Factor) translocation-positive or\n  * When the prognosis is judged to be poor according to NGS-MRD results among high-risk ALL patients (i) In B-ALL, the NGS-MRD(Next Generation Sequencing-Minimal Residual Disease) after consolidation therapy is 0.01% or more, and the NGS-MRD followed during interim maintenance treatment is also 0.01% or more, (ii) In T-ALL, NGS-MRD(Next Generation Sequencing-Minimal Residual Disease) is more than 0.01% after consolidation therapy\n\nExclusion Criteria:\n\n* Participants with contraindications to medications\n* When the study participant or their legal representative withdraws consent\n* Pregnant or lactating women (patients of child-bearing potential require adequate contraception during the study period)\n* Participants who are medically unsuitable to participate in this study at the discretion of the investigator Participants participating in other interventional studies other than this protocol","1 Year","19 Years",{"count":114,"type":20},74,[116],"PHASE2","Very high-risk acute lymphoblastic leukemia",[26],[109,120],"NGS-MRD","2025-06-04",{"date":123,"type":31},"2025-06-08",{"date":125,"type":31},"2024-10-20",{"date":127,"type":20},"2034-12-31",{"name":129,"class":38},"Hyoung Jin Kang",6,{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":138,"enrollmentInfo":139,"targetDuration":4,"studyType":21,"phases":141,"briefSummary":143,"conditions":144,"keywords":145,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":165},"100335119","phase-3-treatment-protocol-for-children-and-adolescents-with-acute-lymphoblastic-leukemia---aieop-bfm-all-2017-100335119","NCT03643276","Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017","International Collaborative Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017","Inclusion Criteria:\n\n* newly diagnosed acute lymphoblastic leukemia or\n* newly diagnosed mixed phenotype acute leukemia (MPAL) meeting one of the following criteria:\n* biphenotypic with a dominant T or B lineage assignment\n* bilineal either with a dominant lymphoblastic population or if another reasonable rationale exists to treat the patient with an ALL-based therapy regimen\n* newly diagnosed acute undifferentiated leukemia\n* age \\\u003C 18 years (up to 17 years and 365 days) at the day of diagnosis\n* patient enrolled in a participating center\n* written informed consent to trial participation and transfer and processing of data A subsequent removal from the study is only allowed if the inclusion criteria turn out not to be fulfilled or in the case of pregnancy of the patient.\n\nExclusion Criteria:\n\n* Ph+ (BCR-ABL1 or t(9;22)-positive) ALL\n* bilineal leukemia with a lymphoblastic and a separate non-lymphoblastic (≥ 10% of total cells) blast subset\n* pre-treatment with cytostatic drugs\n* glucocorticoid pre-treatment with ≥ 1 mg\u002Fkg\u002Fd for more than two weeks during the last month before diagnosis\n* treatment started according to another protocol\n* underlying disease that does not allow treatment according to the protocol (e.g. severe congenital heart disease, Charcot-Marie Syndrome, Ataxia-teleangiectasia…)\n* ALL diagnosed as second malignancy and preceding chemotherapy and\u002For radiotherapy\n* evidence of pregnancy or lactation period\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* participation in another clinical trial except for add-on trials within the scope of supportive care approved by the sponsor\n* live vaccine immunization within 2 weeks before start of protocol treatment","17 Years",{"count":140,"type":20},5000,[142],"PHASE3","The understanding of acute lymphoblastic leukemia (ALL) in childhood and adolescence has largely changed due to extensive genetic research in recent years: ALL is now considered to be a very heterogeneous disease group. The leukemia cells present themselves with quite differently activated regulatory mechanisms of the malignant phenotype. The introduction of more accurate methods of assessing therapy response (\"minimal residual disease \\[MRD\\] tests\") has provided new insights into very different mechanisms of action, including factors influenced by host factors; this has had practical clinical consequences for the use of more individualized therapy. Multimodal therapies have enabled a cure level of over 80% for ALL in this age group. However, the own and international study data show that the therapy toxicity of the contemporary chemotherapy concepts has become unacceptably high, in particular with respect to those intensified therapies used for the treatment of patients at high risk of ALL relapse.\n\nThe AIEOP-BFM ALL 2017 study therefore aims for an innovative integrated approach that will not only adapt the risk stratification to new prognostic markers using more comprehensive diagnostics, but above all, qualitatively reorient the therapy. The most important consequence will be that this study is testing immunotherapy with the bispecific antibody blinatumomab as an alternative to particularly intensive and toxic chemotherapy elements in precursor B-cell ALL (pB-ALL) patients with detectable chemotherapy resistance and at high risk of relapse. With the aim to complement the effects of the conventional chemotherapy, Blinatumomab is in addition tested in the large group of pB-ALL patients at intermediate relapse risk with seemingly unremarkable leukemia, but who account for a large proportion of all relapses. Targeted therapy is also used in the form of the proteasome inhibitor bortezomib for patients with pB-ALL and slow response to the drugs of the induction chemotherapy with the aim to overcome intrinsic chemotherapy resistance of the ALL cells. In patients with T-lineage ALL, who have particularly poor chances for cure after relapse, the established consolidation chemotherapy has proved to be particularly effective. This chemotherapy phase is therefore tested in a longer and more intensive form in such T-ALL patients with intermediate or slow early treatment response with the aim to reduce the relapses rate in this subgroup.",[26],[146,147,148,149,150,151,152,153,154,155],"Acute Lymphoblastic Leukemia","Childhood","Pediatric","Immunotherapy","Blinatumomab","Proteasome Inhibitor","Bispecific antibody","Bortezomib","Chemotherapy","Randomized trial","2025-04-03",{"date":158,"type":31},"2025-04-06",{"date":160,"type":31},"2018-07-15",{"date":162,"type":20},"2028-07-14",{"name":164,"class":38},"Martin Schrappe",115,{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":15,"minAge":111,"maxAge":138,"enrollmentInfo":173,"targetDuration":4,"studyType":21,"phases":175,"briefSummary":176,"conditions":177,"keywords":179,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":39},"100582712","cd-19-car-t-cell-for-pediatric-all-or-lymphoma-100582712","NCT06866873","CD-19 CAR-T Cell for Pediatric ALL or Lymphoma","Safety and Feasibility Study of CD19 Chimeric Antigen Receptor (CAR) T Cells in Children with Relapsed or Refractory CD19 Positive Acute Lymphoblastic Leukemia or Lymphoma","Inclusion Criteria:\n\n* Subjects must have relapsed or refractory ALL or lymphoma treated with at least two lines of therapy. Disease must have either progressed after the last regimen or presented failure to achieve partial or complete remission with the last regimen.\n* The patient's disease must be CD19 positive, either by immunohistochemistry or flow cytometry analysis on the last biopsy available.\n* Age 1-17 years.\n* Performance status: Subjects \\> 10 years of age: Karnofsky ≥ 50%; Subjects ≤ 10 years of age: Lansky scale ≥ 50%.\n* Normal organ function.\n\n  * Total bilirubin ≤ 3 times upper limit of normal\n  * AST (SGOT) ≤ 5 times upper limit of normal\n  * ALT (SGPT) ≤ 5 times upper limit of normal\n  * Serum Creatinine ≤ 2 times upper limit of normal\n  * Subjects must have the following hematologic function parameters: Hemoglobin (Hb) level \\> 8 g\u002FdL; Absolute Lymphocyte Count \\> 0.1x10\\^9\u002FL; Platelet \\> 50x10\\^9\u002FL\n* Prior therapy wash-out. At least 2 weeks or 5 half lives, whichever is shorter, must have elapsed since any prior systemic therapy at the time the subject is planned for leukapheresis.\n* Subjects' parent or legal guardian must have the ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Autologous transplant within 6 weeks of planned CAR T cell infusion.\n* Recipient of CAR-T cell therapy outside of this protocol.\n* Active central nervous system (CNS) or meningeal involvement by tumor.\n* History of additional active malignancy other than non-melanoma skin cancer, carcinoma in situ (e.g. cervix, bladder, breast).\n* Active human immunodeficiency virus (HIV) infection.\n* Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant or breastfeeding women.\n* Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy.\n* Serologic status reflecting active hepatitis B or C infection.",{"count":174,"type":20},18,[23],"This study seeks to examine the efficacy and safety of the administration of autologous T cells that have been modified through the introduction of a chimeric antigen receptor (CAR) targeting the B cell surface antigen CD19 following administration of chemotherapy lymphodepletion regimen in children with relapsed or refractory acute lymphoblastic leukemia (ALL) or lymphoma. The overall goal of this study is to validate the safety profile of administration CD19-CAR T cells and describe the response rate in children with relapsed\u002Frefractory ALL or lymphoma.",[178,26],"Lymphoma, B-Cell",[180,148],"CAR-T cell","2025-03-04",{"date":183,"type":31},"2025-03-10",{"date":185,"type":31},"2024-05-01",{"date":187,"type":20},"2037-12-31",{"name":189,"class":38},"Hong Kong Children's Hospital",{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":4,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":15,"minAge":111,"maxAge":138,"enrollmentInfo":197,"targetDuration":4,"studyType":21,"phases":199,"briefSummary":200,"conditions":201,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":39},"100559466","phase-2-a-prospective-open-label-randomized-controlled-multicenter-clinical-study-of-msd-hsct-using-a-tbi-or-tmli-conditioning-regimen-for-pediatric-all-100559466","NCT06564493","A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of MSD-HSCT Using a TBI or TMLI Conditioning Regimen for Pediatric ALL","A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of Matched Sibling Donor Hematopoietic Stem Cell Transplantation Using a TBI or TMLI Conditioning Regimen for Pediatric Lymphoblastic Leukemia","Inclusion Criteria:\n\n1. Informed Consent: Participants or guardians must voluntarily sign a written informed consent form.\n2. Age and Gender: Participants should be male or female, aged 1-17 years, inclusive.\n3. Diagnosis: Participants must be diagnosed with acute lymphoblastic leukemia (ALL) according to World Health Organization (WHO) criteria, and the diagnosis must apply to pediatrics aged 1-17 years.\n4. Remission Status: The participant's leukemia must be in hematologic remission (complete remission, CR) prior to transplantation.\n5. Donor Availability: There must be a suitable matched sibling donoravailable, and the participant must consent to undergo MSD hematopoietic stem cell transplantation (MSD-HSCT).\n6. Karnofsky Performance Status: The participant must have a Karnofsky score of 70 or higher, indicating that they are capable of caring for themselves and carrying out normal activities. Additionally, they must not have significant organ dysfunction, defined by the following:\n\n   * Cardiac Function: New York Heart Association (NYHA) classification of class II or lower.\n   * Liver Function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be no more than 2.5 times the upper limit of normal. Bilirubin levels should be no more than 2 times the upper limit of normal.\n   * Renal Function: Serum creatinine levels should be no more than 1.5 times the upper limit of normal, or the creatinine clearance rate should be at least 60 ml\u002Fmin. o Pulmonary Function: Participants should not experience significant dyspnea, should not require oxygen therapy, should not have interstitial lung disease, and should not have any active pulmonary infections.\n\nExclusion Criteria: To be eligible for inclusion in the study, participants must not meet any of the following criteria:\n\n1\\. The patient has not achieved hematologic remission before transplantation. 2. The patient has chosen a non-MSD donor.\n\n3\\. The patient has severe cardiac, hepatic, renal, or pulmonary diseases that make them unable to tolerate the conditioning regimen.\n\n4\\. The patient has an active or refractory infection, or other life-threatening complications.\n\n5\\. The patient has a history of other malignant tumors, psychiatric disorders, or HIV infection.\n\n6\\. The patients or guardians refuses to sign the informed consent form, is unwilling to comply with clinical follow-up required by the study, or does not consent to the use of their data to support future research, project presentations, and clinical practices.\n\n7\\. The investigator deems the patient unsuitable for participation in the study for any other reason.",{"count":198,"type":20},170,[116],"This study aims to compare the effects of two different conditioning regimens on patients with acute lymphoblastic leukemia (ALL) undergoing matched sibling donor hematopoietic stem cell transplantation (MSD-HSCT): Total Body Irradiation (TBI) and Total Marrow, Central Nervous System and Lymphoid Irradiation (TMLI). Both regimens are supported and recommended by literature; however, there is no definitive evidence favoring one over the other. We hypothesize that the TMLI regimen, compared to the TBI regimen, may more effectively eliminate leukemia cells in the bone marrow and lymphoid tissues, thereby reducing the risk of relapse, while also minimizing damage to normal tissues, thus reducing conditioning-related toxicity and transplant-related mortality. This study aims to provide evidence for the optimal conditioning regimen for MSD-HSCT in pediatric ALL patients, with the goal of improving patient quality of life and survival outcomes.",[26],"2025-02-16",{"date":204,"type":31},"2025-02-18",{"date":206,"type":20},"2025-03-01",{"date":208,"type":20},"2029-12-31",{"name":210,"class":38},"The First Affiliated Hospital of Zhengzhou University",{"id":212,"slug":213,"hasResults":11,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":11,"sex":15,"minAge":111,"maxAge":138,"enrollmentInfo":218,"targetDuration":4,"studyType":21,"phases":220,"briefSummary":221,"conditions":222,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":223,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":39},"100559070","phase-2-a-prospective-open-label-randomized-controlled-multicenter-clinical-study-of-haplo-hsct-using-a-tbi-or-tmli-conditioning-regimen-for-pediatric-all-100559070","NCT06559345","A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of Haplo-HSCT Using a TBI or TMLI Conditioning Regimen for Pediatric ALL","A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of Haploidentical Hematopoietic Stem Cell Transplantation Using a TBI or TMLI Conditioning Regimen for Pediatric Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n1. Informed Consent: Participants or guardians must voluntarily sign a written informed consent form.\n2. Age and Gender: Participants should be male or female, aged 1-17 years, inclusive.\n3. Diagnosis: Participants must be diagnosed with acute lymphoblastic leukemia (ALL) according to World Health Organization (WHO) criteria, and the diagnosis must apply to pediatrics aged 1-17 years.\n4. Remission Status: The participant's leukemia must be in hematologic remission (complete remission, CR) prior to transplantation.\n5. Donor Availability: There must be a suitable haploidentical donor available, and the participant must consent to undergo haploidentical hematopoietic stem cell transplantation (haplo-HSCT).\n6. Karnofsky Performance Status: The participant must have a Karnofsky score of 70 or higher, indicating that they are capable of caring for themselves and carrying out normal activities. Additionally, they must not have significant organ dysfunction, defined by the following:\n\n   * Cardiac Function: New York Heart Association (NYHA) classification of class II or lower.\n   * Liver Function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be no more than 2.5 times the upper limit of normal. Bilirubin levels should be no more than 2 times the upper limit of normal.\n   * Renal Function: Serum creatinine levels should be no more than 1.5 times the upper limit of normal, or the creatinine clearance rate should be at least 60 ml\u002Fmin.\n   * Pulmonary Function: Participants should not experience significant dyspnea, should not require oxygen therapy, should not have interstitial lung disease, and should not have any active pulmonary infections.\n\nExclusion Criteria:\n\nTo be eligible for inclusion in the study, participants must not meet any of the following criteria:\n\n1. The patient has not achieved hematologic remission before transplantation.\n2. The patient has chosen a non-haploidentical related donor.\n3. The patient has severe cardiac, hepatic, renal, or pulmonary diseases that make them unable to tolerate the conditioning regimen.\n4. The patient has an active or refractory infection, or other life-threatening complications.\n5. The patient has a history of other malignant tumors, psychiatric disorders, or HIV infection.\n6. The patients or guardians refuses to sign the informed consent form, is unwilling to comply with clinical follow-up required by the study, or does not consent to the use of their data to support future research, project presentations, and clinical practices.\n7. The investigator deems the patient unsuitable for participation in the study for any other reason.",{"count":219,"type":20},276,[116],"This study aims to compare the effects of two different conditioning regimens on patients with acute lymphoblastic leukemia (ALL) undergoing haploidentical allogeneic hematopoietic stem cell transplantation (haplo-HSCT): Total Body Irradiation (TBI) and Total Marrow, Central Nervous System and Lymphoid Irradiation (TMLI). Both regimens are supported and recommended by literature; however, there is no definitive evidence favoring one over the other. We hypothesize that the TMLI regimen, compared to the TBI regimen, may more effectively eliminate leukemia cells in the bone marrow and lymphoid tissues, thereby reducing the risk of relapse, while also minimizing damage to normal tissues, thus reducing conditioning-related toxicity and transplant-related mortality. This study aims to provide evidence for the optimal conditioning regimen for haplo-HSCT in pediatric ALL patients, with the goal of improving patient quality of life and survival outcomes.",[26],{"date":204,"type":31},{"date":225,"type":20},"2025-03-17",{"date":227,"type":20},"2029-08-31",{"name":210,"class":38},{"id":230,"slug":231,"hasResults":11,"nctId":232,"briefTitle":233,"officialTitle":233,"acronym":234,"eligibilityCriteria":235,"healthyVolunteers":11,"sex":15,"minAge":236,"maxAge":4,"enrollmentInfo":237,"targetDuration":4,"studyType":21,"phases":239,"briefSummary":240,"conditions":241,"keywords":242,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":39},"100571621","virtual-reality-during-lumbar-punctures-in-acute-lymphoblastic-leukemia-100571621","NCT06722638","Virtual Reality During Lumbar Punctures in Acute Lymphoblastic Leukemia","VIRALL","Inclusion Criteria:\n\n* Initial diagnosis of ALL or Lymphoma (as they receive the same therapy)\n* In maintenance phase of treatment\n* Still have 2 maintenance cycles planned\n* Aged 7 and over\n* Patient able to speak English\n* Caregiver able to complete consent and study questionnaires in English or Spanish\n\nExclusion Criteria:\n\n* Relapsed or refractory disease\n* Previously required ultrasound guided LP procedure\n* Already does LPs without anesthesia","7 Years",{"count":238,"type":20},40,[23],"Over 90% of children and adolescents diagnosed with acute lymphoblastic leukemia (ALL) will survive long term. Part of the successful treatment that patients receive is the delivery of chemotherapy directly into their spinal fluid via a spinal tap. This takes place approximately 20 times over the course of treatment. Most children and adolescents receive general anesthesia during this procedure to manage pain and anxiety. It is now understood that general anesthesia contributes to impairments in brain functioning in the long term. Therefore, it is important to identify ways to manage pain and anxiety during these procedures that does not include general anesthesia. The investigators propose to test whether virtual reality (VR: a technology that provides immersive experiences utilizing content uploaded on a headset), used with local anesthesia and the option for an anti-anxiety medication will be an adequate replacement for general anesthesia for participants 7 years of age and over, with ALL in the maintenance phase of treatment.",[26],[243,244],"Virtual Reality","Lumbar Puncture","2024-12-03",{"date":247,"type":31},"2024-12-09",{"date":249,"type":31},"2024-08-30",{"date":251,"type":20},"2026-12",{"name":253,"class":38},"Children's National Research Institute",{"id":255,"slug":256,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":4,"eligibilityCriteria":260,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":261,"targetDuration":4,"studyType":21,"phases":263,"briefSummary":264,"conditions":265,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":73},"100337673","phase-1-treatment-of-patients-with-relapsed-or-refractory-cd19-lymphoid-disease-with-t-cells-expressing-a-third-generation-car-100337673","NCT03676504","Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Cells Expressing a Third-generation CAR","Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Lymphocytes Transduced by RV-SFG.CD19.CD28.4-1BBzeta Retroviral Vector - a Unicenter Phase I\u002FII Clinical Trial","Inclusion Criteria:\n\nStratum I\u002FII (Adults):\n\n* Confirmed CD19+ ALL, CLL, DLBCL, FL or MCL in patients ≥ 18 years\n* ALL (Ph+ and Ph-): Confirmed CD19+ ALL by cytology and flow cytometry (FACS) AND\n* Relapsed or refractory disease (including \"molecular relapse\" with minimal residual disease (MRD) levels \\> 10\\^-3 at two occasions \\> 2 weeks apart) with confirmed CD19 expression on malignant cells in relapse\n\n  * Any relapse after allogeneic stem cell transplantation (alloSCT) (≥ 6 months from alloSCT at time of CAR T cell infusion) OR\n  * Any relapse failing to achieve an MRD level of \\\u003C 10\\^-3 after ≥ 2 lines of treatment OR\n  * Primary refractory as defined by not achieving a complete remission (CR) after ≥ 2 lines of treatment\n* CLL\u002FNHL: Confirmed CD19+ CLL\u002FNHL (including CLL, DLBCL, FL or MCL) with\n\n  * CLL in need of treatment with:\n\n    1. Early relapse (within 2 years) after end of chemoimmunotherapy or chemoimmunotherapy refractoriness plus failure or intolerance of both Bruton's tyrosine kinase Inhibitor (BTKi) and B-cell lymphoma 2 inhibitors (BCL-2i) OR\n    2. Relapse after alloSCT, ineligible for or refractory to standard interventions (donor lymphocyte infusions (DLI), CD20 antibodies, chemoimmunotherapy)\n  * DLBCL with:\n\n    1. Refractoriness to a 2nd or later line of chemoimmunotherapy OR\n    2. Relapse after autologous stem cell transplantation (autoSCT) plus ineligibility for alloSCT (including refractoriness to one line of salvage chemoimmunotherapy) OR\n    3. Relapse after alloSCT\n  * FL in need of treatment with:\n\n    1. Relapse \\\u003C2 years after chemoimmunotherapy AND ineligibility for or failure of autologous stem cell transplantation (autoSCT) AND ineligibility for or failure of idelalisib OR\n    2. Relapse after alloSCT, ineligible for or refractory to standard interventions (DLI, CD20 antibodies, chemoimmunotherapy)\n  * MCL with:\n\n    1. Relapse after standard first-line therapy AND ineligibility for or failure to BTKi salvage therapy OR\n    2. Relapse after alloSCT AND ineligibility for or failure to BTKi salvage therapy\n* Measurable disease\u002FMRD at time of enrollment\n* Life expectancy ≥ 12 weeks\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 at the time of screening\n* Adequate organ function:\n\n  * Renal function defined as: serum creatinine of ≤ 2 x ULN or estimated glomerular filtration rate (eGFR) ≥ 30 mL\u002Fmin\u002F1.73 m\\^2\n  * Liver function defined as:\n  * ALT ≤ 5 times the ULN for the respective age\n  * Bilirubin ≤ 2.0 mg\u002Fdl with the exception of patients with hyperbilirubinemia explained by Gilbert-Meulengracht syndrome (may be included if total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN) or extrahepatic disease (e.g. chronic hemolytic anemia)\n  * minimum level of pulmonary reserve defined as ≤ grade 1 dyspnea and pulse oxygenation \\> 90% on room air\n  * Hemodynamic stability and left ventricular ejection fraction (LVEF) ≥ 40% as confirmed by echocardiogram\n  * Absolute neutrophil count (ANC) ≥ 500\u002Fmm3\n  * Absolute lymphocyte count (ALC) ≥ 100\u002Fmm3\n* Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) and all male participants must agree to use highly effective methods of contraception for one year following CD19.CAR T cell therapy\n* Ability to understand the nature of the trial and the trial related procedures\n* Written informed consent must be obtained prior to any screening procedures\n\nStratum III (Children and Adolescents with ALL):\n\n* Age of \\> 3 years until \\\u003C 18 years at the time of screening\n* CD19+ ALL (Ph+ and Ph-) confirmed by cytology and flow cytometry (FACS) AND\n* Relapsed or refractory disease (including \"molecular relapse\" with polymerase chain reaction (PCR) MRD \\> 10\\^-3 at two occasions \\> 2 weeks apart) with confirmed CD19 expression on malignant cells in relapse\n\n  * Any relapse after alloSCT (≥ 6 months from alloSCT at time of CAR T cell infusion) OR\n  * Any relapse failing to achieve an MRD level of \\\u003C 10\\^-3 after ≥ 2 lines of treatment OR\n  * Primary refractory as defined by not achieving a CR after ≥ 2 lines of treatment\n* Measurable disease\u002FMRD at time of enrollment\n* Life expectancy ≥ 12 weeks\n* ECOG performance status ≤ 2 (age ≥ 16 years) or Lansky performance status ≥ 50 (age \\\u003C 16 years) at the time of screening\n* Adequate organ function:\n\n  * Renal function defined as serum creatinine-clearance ≥ 30 mL\u002Fmin\u002F1.73 m\\^2\n  * Liver function defined as:\n  * ALT ≤ 5 times the ULN for the respective age\n  * Bilirubin ≤ 2.0 mg\u002Fdl with the exception of patients with hyperbilirubinemia explained by Gilbert-Meulengracht syndrome or extrahepatic disease (e.g. chronic hemolytic anemia)\n  * minimum level of pulmonary reserve defined as ≤ grade 1 dyspnea and pulse oxygenation \\> 90% on room air\n  * Hemodynamic stability and LVEF ≥ 40% or shortening fraction \\> 29% as confirmed by echocardiogram\n  * ANC) ≥ 500\u002Fmm3\n  * ALC ≥ 100\u002Fmm3\n* Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) and postpubertal male participants must agree to use highly effective methods of contraception for one year following CD19.CAR T cell therapy\n* Written informed consent of the study patient and\u002For the legal representative must be obtained prior to any screening procedures\n\nExclusion Criteria:\n\nStratum I\u002FII (Adults):\n\n* The following medications are excluded:\n\n  * Immunosuppressive medication with the exception of ≤ 30 mg prednisolone\u002Fd or equivalent at the time of CAR T cell transfusion\n  * Bridging\u002Fmaintenance therapy including chemo- and immunotherapy must be stopped ≥ 2 weeks prior to leukapheresis, but can be continued between leukapheresis and lymphodepletion\n* Intrathecal chemotherapy is possible at any time, but not during lymphodepletion until 14 days after CD19.CAR T cell transfusion\n* Any DLI must be completed \\> 6 weeks prior to CD19.CAR T cell infusion\n* Florid\u002Facute or chronic Graft-versus-Host disease (GvHD)\n* Uncontrolled active hepatitis B or C\n* HIV-positivity\n* Uncontrolled acute life-threatening bacterial, viral or fungal infection\n* Severe concomitant disease (e.g. uncontrolled arterial hypertension, heart failure New York Heart Association (NYHA) III-IV, uncontrolled diabetes mellitus, uncontrolled hyperlipidemia)\n* Unstable angina and\u002For myocardial infarction within 3 months prior to screening\n* Any previous or concurrent malignancy.\n\nThe following exceptions do NOT constitute exclusion criteria:\n\n* Adequately treated basal cell or squamous cell carcinoma (adequate wound healing is required prior to study entry)\n* In situ carcinoma of the cervix or breast, treated curatively without evidence of recurrence ≥ 3 years prior to the study\n* CLL or FL transformed into an aggressive B cell lymphoma\n* A primary malignancy which is in complete remission for ≥ 5 years\n\n  * Pregnant or nursing (lactating) women\n  * Intolerance to the excipients of the cell product\n  * Active central nervous System (CNS) involvement in ALL patient at the time of screening is not an exclusion criterion, but patients with CNS 3 status at clinical screening (d-14) are not eligible for CD19.CAR T cell transfusion\n  * Participation in another clinical trial at the time of screening\n\nStratum III (Children and Adolescents with ALL):\n\n* The following medications are excluded:\n\n  * immunosuppressive medication with the exception of \\\u003C 0.5 mg\u002Fd\\*kg body weight (BW) prednisolone-equivalent at the time of CD19.CAR T cell transfusion\n  * Bridging\u002FMaintenance therapy including chemo- and immunotherapy must be stopped ≥ 2 weeks prior to leukapheresis, but can be continued between leukapheresis and lymphodepletion\n* Intrathecal chemotherapy is possible at any time, but not during lymphodepletion until 14 days after CD19.CAR T cell transfusion\n* Any DLI must be completed \\> 6 weeks prior to CD19.CAR T cell infusion\n* Florid\u002Facute or chronic GvHD\n* Uncontrolled active hepatitis B or C\n* HIV-positivity\n* Uncontrolled acute life-threatening bacterial, viral or fungal infection\n* Severe concomitant disease (e.g. any life-limiting genetic disorder). Patients with Down Syndrome will not be excluded.\n* Any previous or concurrent malignancy.\n\nThe following exceptions do not constitute exclusion criteria:\n\n* Lymphoblastic lymphoma transformed into a CD19+ acute lymphoblastic leukemia\n* A primary malignancy which is in complete remission for ≥ 5 years\n\n  * Pregnant or nursing (lactating) women\n  * Intolerance to the excipients of the cell product\n  * Active CNS involvement at the time of screening is not an exclusion criterion, but patients with CNS 3 status at clinical screening (d-14) are not eligible for CD19.CAR T cell transfusion\n  * Participation in another clinical trial at the time of screening",{"count":262,"type":20},68,[85,116],"Adult patients with r\u002Fr acute lymphoblastic leukemia (ALL) (stratum I), r\u002Fr Non-Hodgkin's lymphoma (NHL) including chronic lymphocytic leukaemia (CLL), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) or mantle cell lymphoma (MCL) (stratum II) as well as paediatric patients with r\u002Fr ALL (stratum III) will be treated with autologous T-lymphocytes transduced by the third-generation RV-SFG.CD19.CD28.4-1BBzeta retroviral vector. The main purpose of this study is to evaluate safety and feasibility of escalating CD19.CAR T cell doses (0,1-20×20\\^7 transduced cells\u002Fm\\^2) after lymphodepletion with fludarabine and cyclophosphamide.",[266,26,267,268,269,270],"Acute Lymphoblastic Leukemia, Adult","Chronic Lymphocytic Leukemia","Diffuse Large B Cell Lymphoma","Follicular Lymphoma","Mantle Cell Lymphoma","2024-07-26",{"date":273,"type":31},"2024-07-29",{"date":275,"type":31},"2018-09-07",{"date":277,"type":20},"2027-12-31",{"name":279,"class":38},"University Hospital Heidelberg",{"id":281,"slug":282,"hasResults":11,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":4,"eligibilityCriteria":286,"healthyVolunteers":11,"sex":15,"minAge":287,"maxAge":288,"enrollmentInfo":289,"targetDuration":4,"studyType":21,"phases":291,"briefSummary":292,"conditions":293,"keywords":295,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":39},"100441527","phase-3-combined-immuno-chemotherapy-for-patients-with-b-linear-acute-lymphoblastic-leukemia-diagnosed-from-0-to-365-days-of-life-all-baby-2021-100441527","NCT05029531","Combined Immuno-chemotherapy for Patients With B-linear Acute Lymphoblastic Leukemia Diagnosed From 0 to 365 Days of Life (ALL-Baby-2021)","Prospective Single Group Study Combined Immuno-hemotherapy for Patients With B-linear Acute Lymphoblastic Leukemia Diagnosed From 0 to 365 Days of Life (ALL-Baby-2021)","Inclusion Criteria:\n\n* Age at diagnosis at 1 to 365 days of life.\n* The start of induction therapy within a time interval of study recruitment phase.\n* The diagnosis of ALL is to be proved by the morphological, cytochemical, and immunological analysis of tumor cells in bone marrow (see \"Diagnostics\"). Patients with B-cell (Burkitt) ALL are excluded.\n* Informed consent of the patient parents (guardians) to be treated in one of the clinics included in this study.\n\nExclusion Criteria:\n\n* The disease is a relapse of previously misdiagnosed and, therefore, inadequately treated ALL;\n* There is severe concomitant disease, which significantly impedes chemotherapy protocol (such as multiple malformations, heart diseases, metabolic disorders, etc.);\n* There is a lack of important data needed for the exact adherence to the cytostatic therapy according to a specific chemotherapy protocol (differential diagnosis of ALL-AML (acute myeloid leukemia) is not possible, stratification according to therapeutic group is not possible);\n* The patient was treated before for a long time with cytotoxic drugs;\n* There were treatment deviations not covered by the protocol and\u002For not due to side effects of treatment and\u002For complications of the disease","1 Day","365 Days",{"count":290,"type":20},80,[142],"The innovation of this protocol is the risk-adapted choice of therapy and the use of a combination of chemotherapy with immunotherapy and hematopoietic stem cell transplantation for patients with risk factors. Investigators have proposed a two-stage stratification into risk groups:\n\nInitially:\n\n* Standard risk: patients with no rearrangement of the KMT2A gene.\n* Intermediate risk: patients with rearrangement of the KMT2A gene without damage to the central nervous system.\n* High risk: patients with rearrangement of the KMT2A gene with lesions of the central nervous system.\n\nAccording to the results of induction therapy:\n\n* The high-risk group includes patients from the standard risk group with an MRD level of more than 0.1% after the induction course and from the intermediate risk group with MRD-positive (PCR) after HR1 block.\n* The allocation of children in the first year of life without the rearranged KMT2A gene into a separate group seems to be logical, since the prognosis in this group is better than in children with the rearranged KMT2A gene. In this protocol, non-intensive therapy with consolidations and maintenance therapy remains for those who achieve a low MRD level (less than 0.1%) after a course of induction. The rest of the patients move into a high-risk group: they receive blinatumomab and HSCT.\n* The concept of therapy for patients at intermediate risk is based on the rate at which MRD-negativity is achieved: standard consolidation and maintenance therapy for those who became MRD-negative at the end of induction, \"block\" chemotherapy for those who were positive at the end of induction, but achieved negativity after HR1 block, blinatumomab with HSCT for those who have preserved the MRD after the HR1 block.\n* For high-risk patients, a combination of immunotherapy (blinatumomab - a bispecific CD3 \u002F CD19 T-cell activator) and HSCT in the first remission was chosen.",[26,294],"ALL, Infants",[296,297,298,299,149,150,300],"Acute lymphoblastic leukemia","children","infant","treatment сhemotherapy","Stemm Cell Transplantation","2024-06-26",{"date":303,"type":31},"2024-06-28",{"date":305,"type":31},"2021-09-23",{"date":307,"type":20},"2030-07-01",{"name":309,"class":38},"Federal Research Institute of Pediatric Hematology, Oncology and Immunology"]