[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Federal Research Institute of Pediatric Hematology, Oncology and Immunology\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":377},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,50,84,109,139,167,198,227,257,278,298,317,343],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100621818","phase-3-chemoimmunotherapy-combined-with-autologous-nk-cell-therapy-for-pediatric-patients-with-refractory-and-relapsed-high-risk-neuroblastoma-and-ganglioneuroblastoma-100621818",false,"NCT07375563","Chemoimmunotherapy Combined With Autologous NK Cell Therapy for Pediatric Patients With Refractory and Relapsed High-Risk Neuroblastoma and Ganglioneuroblastoma","Chemoimmunotherapy Combined With Autologous NK Cell Therapy for the Treatment of Pediatric Patients With Refractory and Relapsed High-Risk Neuroblastoma and Ganglioneuroblastoma","NB-NK-2026","Inclusion Criteria:\n\n* Signed voluntary informed consent to participate in the clinical trial\n* Histologically verified diagnosis of neuroblastoma or ganglioneuroblastoma\n* Patients stratified to the high-risk group according to the criteria of the German Society of Pediatric Oncology and Hematology (GPOH) - NB 2004, aged from 18 months to 18 years, and meeting the following conditions:\n\n  1. Arm A: Refractory disease - patients who have completed the induction phase of therapy (6 cycles of N5\u002FN6) with a poor response to therapy (MR, SD), with the exception of PD\n  2. Arm В: Relapsed\u002Fprogressive disease - patients who develop any new tumor lesions (after having previously achieved СR), or any new tumor lesion; an increase of \\>25% in any previously existing measurable lesion; or newly detected bone marrow involvement by NB cells in cases where the bone marrow had previously been free of involvement\n* Performance status ≥ 70% (Lansky or Karnofsky scale) at the time of determining the indication for chemoimmunotherapy combined with NK cell therapy.\n* Expected life expectancy ≥ 12 weeks.\n* No signs of drug-induced neuropathy or neuropathic pain.\n* Adequate liver function: alanine aminotransferase (ALT) \u002F aspartate aminotransferase (AST) activity \\\u003C 5 × upper limit of normal (ULN).\n* Adequate renal function: creatinine clearance or glomerular filtration rate (GFR) \\> 60 mL\u002Fmin\u002F1.73 m².\n* Coagulation parameters: prothrombin index (PTI) 70-120%; activated partial thromboplastin time (APTT) \\\u003C 36 seconds.\n* No clinical signs of heart failure; left ventricular ejection fraction (LVEF) ≥ 55%.\n* Adequate respiratory function (oxygen saturation by pulse oximetry \\> 94% on room air, no dyspnea at rest), and no pathological findings on chest X-ray.\n* Completion of comprehensive assessment to evaluate the extent of the tumor process.\n\nExclusion Criteria:\n\n* Lack of a signed voluntary informed consent form for participation in the clinical study.\n* Absence of comprehensive pre-treatment assessment results at the time of initiation of specific therapy.\n* Patients with NBL or ganglioneuroblastoma stratified to low or intermediate-risk group\n* Good response (PR, VGPR, CR) or PD at the end of the induction phase of therapy (applicable only to patients receiving therapy within the framework of the intensified induction phase).\n* Progressive or relapsed disease with central nervous system involvement and\u002For leptomeningeal involvement.\n* History of acute intolerance reactions to the main chemotherapeutic and immunobiological agents and supportive care drugs used in this clinical trial protocol.\n* Presence of complications of the underlying disease and comorbidities that preclude treatment within this protocol, including severe type I hypersensitivity reactions in the medical history.\n* Requirement for concomitant medications with known cross pharmacodynamic interactions with the drugs used in this clinical trial protocol.\n* Presence of ultrasonographic signs of heart failure (LVEF ≤ 55%), clinical and laboratory signs of chronic kidney disease of stage ≥ III, or kidney injury of grade I, F or L according to the standardized RIFLE criteria for acute kidney injury (an acronym for \"risk, injury, failure, loss, end-stage\").\n* Pregnancy, due to the high teratogenicity and toxicity of the drugs used in this clinical trial protocol. Female patients of childbearing potential are required to undergo pregnancy testing.\n* Mental illness of the patient or legal guardians that makes it impossible to understand the nature of the study and compromises adherence to medical prescriptions and sanitary-hygienic requirements.","ALL","18 Months","18 Years",{"count":21,"type":22},5,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","Neuroblastoma (NB) is a malignant neoplasm of the sympathetic nervous system, occurring in 1 in 8,000 live births, accounting for 6-10% of all childhood malignant neoplasms and responsible for 12-15% of mortality -, making it the most common and life-threatening extracranial tumor in childhood.\n\nPatients with stage 4 high-risk NB is the subgroup with the poorest prognosis. Within this group, two subgroups with an extremely unfavorable disease course are distinguished: patients with a poor response to the induction phase of therapy (refractory disease) and patients with relapsed or progressive disease.\n\nNowadays, 10-15% of patients show a poor end-induction response, whereas achieving a good end-induction response associated with better long-term survival. Improvement of the response to induction therapy may contribute to better treatment outcomes in newly diagnosed high-risk NB patients and can be achieved by intensification of the induction phase to decrease the number of patients with refractory disease. Also intensification of the second-line therapy may contribute to better responses in patients with relapsed and progressive disease.\n\nProtocol aimed to overcome heterogeneous tumor drug resistance through the synergistic interaction of cytostatic and immunobiological agents in combination with NK cell therapy.\n\nThis approach combines cytotoxic agents with anti-GD2 monoclonal antibodies (mAb) to enhance antitumor activity. Cultured, ex vivo-activated autologous NK cells are infused to compensate for effector cell depletion during therapy and to augment antibody-dependent cellular cytotoxicity (ADCC), potentially improving clinical outcomes.\n\nThis comprehensive approach opens novel prospects for enhancing treatment efficacy in patients with refractory and relapsed high-risk NB.\n\nThe expected outcomes of this protocol include a significant increase in therapeutic efficacy indicators - objective response rate (ORR), overall survival (OS), progression-free survival (PFS) and relapse-free survival (RFS), as well as in patient quality of life.",[28,29],"Neuroblastoma (NB)","Ganglioneuroblastoma",[31,32,33,34,35,36],"Refractory\u002Frelapsed neuroblastoma","ganglioneuroblastoma","children","autologous NK cells","chemoimmunotherapy","dinutuximab beta","RECRUITING","2026-01-21",{"date":40,"type":41},"2026-01-29","ACTUAL",{"date":43,"type":41},"2025-11-19",{"date":45,"type":22},"2028-11-19",{"name":47,"class":48},"Federal Research Institute of Pediatric Hematology, Oncology and Immunology","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":23,"phases":61,"briefSummary":63,"conditions":64,"keywords":69,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":49},"100621144","phase-2-co-infusion-of-treg-enriched-donor-lymphocytes-with-cd3-depleted-hematopoietic-stem-cell-graft-to-prevent-graft-versus-host-disease-after-allogeneic-hematopoietic-stem-cell-transplantation-among-children-with-hematologic-malignancies-100621144","NCT07366801","Co-infusion of Treg-enriched Donor Lymphocytes With CD3-depleted Hematopoietic Stem Cell Graft to Prevent Graft-versus Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation Among Children With Hematologic Malignancies","Pilot Study of Co-Infusion of Donor Lymphocytes Enriched With Regulatory T Lymphocytes With Ex-vivo CD3-Depleted Hematopoietic Stem Cell Graft for the Prevention of Graft-versus-Host Disease in Children With Hematopoietic and Lymphoid Tissue Neoplasms","Inclusion Criteria:\n\n1. Informed consent signed by the patient (age 14 to 25 years) and\u002For his\u002Fher legal representative (age 0 to 18 years).\n2. The patient has an indication for allogeneic hematopoietic stem cell transplantation (HSCT) established in accordance with the current regulatory framework\n3. Planned HSCT from a haploidentical donor\n4. The Karnofsky or Lansky score is more than 70%\n5. Life expectancy of at least 8 weeks\n6. Heart function: ejection fraction of at least 40%\n7. Consent to continue follow-up for 3 years\n\nExclusion Criteria:\n\n1. Acute viral hepatitis or acute HIV infection\n2. Hypoxemia with SaO2 \\\u003C90%\n3. Bilirubin \\>3 normal\n4. Creatinine \\>3 norms\n5. Pregnancy and lactation\n6. Life-threatening infection\n7. Severe (\\>?) pathology of the central nervous system (epilepsy, dementia, organic damage to the central nervous system)\n8. Karnofsky score or Lansky score \\\u003C70%","1 Year","25 Years",{"count":60,"type":22},64,[62,25],"PHASE2","Two key methods of GVHD prevention in allogeneic HSCT have a number of limitations: ex vivo T depletion is associated with an excess of infectious complications, and pharmacological immunosuppression with insufficient efficacy of GVHD prevention. Modern graft engineering technologies make it possible to create a graft with a balanced cell composition, reducing the risk of adverse events, in particular, severe forms of acute and chronic GVHD, while preserving the immunological function of the graft. In the proposed concept, enrichment of the T graft with regulatory cells will reduce the risk of GVHD and preserve a sufficient number of T lymphocytes in the graft for the formation of protective anti-infective immunity in the early stages after HSCT. The combination of partial T depletion and pharmacological immunosuppression minimized in volume and duration will combine the advantages of T depletion (early engraftment, low risk of GVHD, low risk of organ complications) and pharmacological prophylaxis (restoration of anti-infective immunity).",[65,66,67,68],"Acute Myeloid Leukemia, Relapsed","Acute Lymphoblastic Leukemia, High Risk","Acute Myeloid Leukemia, High Risk","Acute Lymphoblastic Leukemia, Relapse",[70,71,72,73,74,75],"Acute myeloid leukemia","Acute lymphoblastic leukemia","relapse","T regulatory","CD3 depletion","allogeneic HSCT","2026-01-16",{"date":78,"type":41},"2026-01-26",{"date":80,"type":41},"2025-09-03",{"date":82,"type":22},"2028-02-03",{"name":47,"class":48},{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":91,"enrollmentInfo":92,"targetDuration":4,"studyType":23,"phases":94,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":4},"100617282","phase-2-study-of-treosulfan-based-conditioning-for-hsct-in-nijmegen-breakage-syndrome-100617282","NCT07316595","Study of Treosulfan-Based Conditioning for HSCT in Nijmegen Breakage Syndrome","A Clinical Study of the Efficacy and Safety of Conditioning With Low Doses of Treosulfan Before Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Nijmegen Breakage Syndrome","Inclusion Criteria:\n\n* genetically confirmed Nijmegen breakage syndrome\n* availability of informed consent for study participation, signed by the patient (ages 14 to 21) and\u002For their legal representative (ages 0 to 18).\n* absence of contraindications to HSCT based on the patient's somatic status.\n\nExclusion Criteria:\n\n* other DNA repair deficiency syndromes (both specified and unspecified)","21 Years",{"count":93,"type":22},24,[62],"Nijmegen breakage syndrome is one of the DNA repair defect disorders. A characteristic feature of these syndromes is a predisposition to the development of malignant neoplasms. The only curative option for the combined immunodeficiency in Nijmegen breakage syndrome is allogeneic hematopoietic stem cell transplantation (HSCT). In addition to correcting the immunodeficiency, HSCT can reduce the risk of developing hematopoietic tumors.\n\nDue to the increased sensitivity of cells in patients with Nijmegen breakage syndrome to alkylating drugs, the use of standard myeloablative conditioning regimens for this disease significantly increases the risks of toxic complications and transplant-related mortality.\n\nTreosulfan is an alkylating agent that has demonstrated efficacy with comparatively low risks of toxic complications when used as part of conditioning prior to allogeneic HSCT for various diseases in patients of all age groups. There is currently experience using treosulfan in patients with Nijmegen breakage syndrome at reduced doses (21 and 30 g\u002Fm²). However, a number of questions remain unresolved. Based on our previous experience, a dose of 21 g\u002Fm² is sufficient for patients with Nijmegen breakage syndrome without a malignant disease, as it ensures good graft function (a high probability of full donor chimerism and control of the immunodeficiency). At the same time, there is reason to believe that this dose is insufficient to provide an antitumor effect from the conditioning.\n\nWe are planning a multicenter study to investigate treosulfan-based conditioning in patients with Nijmegen breakage syndrome, which will stratify patients based on the presence or absence of malignant disease. Patients without a tumor will receive treosulfan at a dose of 21 g\u002Fm², and patients with a tumor will receive 30 g\u002Fm².",[97,98,99],"HSCT","Nijmegen Breakage Syndrome","Treosulfan Based Conditioning","NOT_YET_RECRUITING","2025-12-18",{"date":103,"type":41},"2026-01-05",{"date":105,"type":22},"2025-12-30",{"date":107,"type":22},"2030-12-31",{"name":47,"class":48},{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":17,"minAge":116,"maxAge":58,"enrollmentInfo":117,"targetDuration":4,"studyType":23,"phases":119,"briefSummary":120,"conditions":121,"keywords":125,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":49},"100612640","phase-2-feasibility-and-safety-of-donor-derived-nk-cell-infusions-for-leukemia-relapse-prophylaxis-after-hematopoietic-stem-cell-transplantation-100612640","NCT07256210","Feasibility and Safety of Donor-derived NK-cell Infusions for Leukemia Relapse Prophylaxis After Hematopoietic Stem Cell Transplantation","Phase I\u002FII Clinical Trial of mbIL21 ex Vivo-expanded Donor-derived NK-cell Infusions With Hematopoietic Stem Cell Transplantation for Disease Relapse Prophylaxis in Pediatric and Young Adult Patients With Chemorefractory or Minimal Residual Disease Positive Acute Leukemia","Inclusion Criteria:\n\n1. Patient (age from 14 to 25 years) and\u002For patient's legal representative (age from 0 to 18 years) should provide written informed consent.\n2. Patients with one of the following disease:\n\n   * Acute myeloid leukemia: a. primary refractory disease (absence of complete remission (CR) after two induction regimens), b. refractory relapse (absence of CR after one salvage regimen), c. MRD-persistence before conditioning (presence of residual leukemic population more than 0,01% of bone marrow nucleated cells by flow cytometry);\n   * Acute T-lymphoblastic leukemia: a. primary refractory disease (absence of complete remission (CR) after two induction regimens), b. refractory relapse (absence of CR after one salvage regimen), c. MRD-persistence before conditioning (presence of residual leukemic population more than 0,1% of bone marrow nucleated cells by flow cytometry);\n   * Acute mixed phenotype leukemia: a. primary refractory disease (absence of complete remission (CR) after two induction regimens), b. refractory relapse (absence of CR after one salvage regimen), c. MRD-persistence before conditioning (presence of residual leukemic population more than 0,01% of bone marrow nucleated cells by flow cytometry).\n3. Patient is indicated to receive allo-HSCT according to actual clinical practice.\n4. Haploidentical or matched related donor was chosen and is available for allo-HSCT (and NK-cell therapy).\n5. Patient's clinical status: Lansky\u002FKarnowski index ≥50%.\n6. Kidney function: clearance of endogenous creatinine or glomerular filtration rate according to Schwarz equation ≥50 ml\u002Fmin\u002F1,73 m2.\n7. Liver function: total bilirubin ≤3 ULN except for Gilbert's disease, ALT\u002FAST ≤3 ULN.\n8. Heart function: left ventricular ejection fraction ≥40%.\n9. Lung function: lung capacity ≥50%, for children who cannot carry out of respiratory function - oxygen saturation during pulse oximetry ≥92% (without supplemental oxygen).\n10. Life expectancy ≥8 weeks.\n11. Patients who agree to long-term follow up for up to 2 years.\n\nExclusion Criteria:\n\n1. Inability to provide or withdrawal of written informed consent.\n2. Cellular therapy including allo-HSCT within prior 4 months period, absence of active signs of GVHD, sinusoidal obstruction syndrome, cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome.\n3. Active hepatitis B, C or HIV infection.\n4. Pregnant or lactating women.\n5. Uncontrolled infection; principal investigator is the final arbiter of this criterion.\n6. Clinical signs of grade ≥3 CNS disorders (seizure disorder, paresis, aphasia, cerebrovascular ischemia\u002Fhemorrhage, severe brain injuries, dementia, organic brain syndrome, psychosis, coordination or movement disorder).\n7. Mental illness of the patient or caregivers, making it impossible to realize the essence of the study and compromising compliance with medical appointments and sanitary and hygienic regime.","1 Month",{"count":118,"type":22},15,[62],"This pilot clinical trial aims to evaluate the feasibility, adverse reactions and maximum tolerated dose of mbIL21 ex vivo-expanded donor-derived NK-cell infusions before and after haploidentical or matched-related hematopoietic stem cell transplantation in a cohort of pediatric and young adult patients with chemorefractory or minimal residual disease (MRD) positive acute leukemia.",[122,123,124],"Acute Myeloid Leukemia","Acute Lymphoblastic T-cell Leukemia","Mixed Phenotype Acute Leukemia",[126,127,128,129,130],"Natural killer cell therapy","Hematopoietic stem cell transplantation","Leukemia, Acute","Refractory Leukemias","Pre-transplantation MRD-positivity","2025-11-20",{"date":133,"type":41},"2025-12-01",{"date":135,"type":41},"2025-05-09",{"date":137,"type":22},"2027-10",{"name":47,"class":48},{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":17,"minAge":147,"maxAge":19,"enrollmentInfo":148,"targetDuration":4,"studyType":23,"phases":150,"briefSummary":151,"conditions":152,"keywords":155,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":49},"100610788","phase-3-the-efficacy-of-therapy-in-patients-with-acute-myeloid-leukemia-and-down-syndrome-in-russia-100610788","NCT07232134","The Efficacy of Therapy in Patients With Acute Myeloid Leukemia and Down Syndrome in Russia","Prospective Non-randomized Multicenter Trial: the Efficacy of Therapy in Patients With Acute Myeloid Leukemia and Down Syndrome in Russia","AML-DS-2025","Inclusion Criteria:\n\n* Age 0-18 years\n* Diagnosis of AML, MDS and presence of Down syndrome (constitutional trisomy 21 and mutation in the GATA1 gene)\n* Signed informed consent\n\nExclusion Criteria:\n\n* Children with Down syndrome and acute lymphoblastic leukemia (ALL)\n* Severe comorbidities with contraindications to the treatment according to the protocol\n* Pre-treatment \\>14 days with intensive induction therapy\n* Refusal of all therapy or important elements of therapy","1 Day",{"count":149,"type":22},100,[25],"This prospective non-randomized multicenter trial created based on protocol ML DS 2006 and aimed at standardization of current therapy approaches and creating a national network for diagnostic, treatment and monitoring of children (0-18 years) with AML and Down syndrome in Russia. Based on the results the investigators expect to increase long-term overall and event-free survival in children with AML and DS and reduce the immediate and remote toxicity of chemotherapy by reducing the dose load of chemotherapeutic drugs.\n\nThe study protocol therapy for all patients includes four chemotherapy blocks:\n\nCourse 1 AIE (cytarabine\u002Fidarubicin\u002Fetoposide) Course 2 AI (cytarabine\u002Fidarubicin) Course 3 HAD (high -dose cytarabine (1g)\u002Fdaunorubicin) Course 4 HA (high-dose cytarabine) Safety to be monitored based on CTCAE v5.0",[153,154],"AML (Acute Myelogenous Leukemia)","Down Syndrome (DS)",[156,157,158,159],"AML","Acute Myelogenous Leukemia","Down Syndrome","DS","2025-11-17",{"date":131,"type":41},{"date":163,"type":41},"2025-07-24",{"date":165,"type":22},"2032-12-30",{"name":47,"class":48},{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":17,"minAge":147,"maxAge":91,"enrollmentInfo":174,"targetDuration":4,"studyType":23,"phases":176,"briefSummary":177,"conditions":178,"keywords":185,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":49},"100574197","phase-2-preventing-of-gvhd-with-post-transplantation-cyclophosphamide-abatacept-vedolizumab-and-ruxolitinib-at-children-and-young-adults-with-hemoblastosis-100574197","NCT06756152","Preventing of GVHD with Post-transplantation Cyclophosphamide, Abatacept, Vedolizumab and Ruxolitinib At Children and Young Adults with Hemoblastosis","Prospective Pilot Study of the Clinical Efficacy and Safety of the Method for Preventing a Graft-versus-host Disease Through the Agency of Using the Combination of Post-transplantation Cyclophosphamide with Abatacept, Vedolizumab and Ruxolitinib At Children and Young Adults with Hemoblastosis After Hematopoietic Stem Cell Transplantation from an Unrelated or Haploidentic Donor","Inclusion Criteria:\n\n1\\. Patients under the age of 21 years with following diseases:\n\n* acute lymphoblastic,\n* myeloblastic,\n* biphenotypic,\n* bilinear leukemia,\n* malignant lymphoma,\n* myelodysplastic syndrome,\n\nExclusion Criteria:\n\nAge over 21 years\n\n* Patients with ALL outside clinical and hematological remission\n* Clinical status:\n\n  * Lansky\u002FKarnowski index \\\u003C70% (supplement No.1)\n  * Heart function: left ventricular ejection fraction \\\u003C40% according to ultrasound of the heart1\n  * Kidney function: clearance of endogenous creatinine \\\u003C 70 ml \u002F min\n  * Liver function: total bilirubin, ALT, AST, ALP \\> 2 norms\n  * Lung function: lung capacity \\\u003C50%, for children who cannot carry out of respiratory function - oxygen saturation during pulse oximetry \\\u003C92%\n* Uncontrolled viral, fungal or bacterial infection.\n* Mental illness of the patient or caregivers, making it impossible to realize the essence of the study and compromising compliance with medical appointments and sanitary and hygienic regime 1 These patients may receive treatment according to the protocol, but the results will be evaluated separately",{"count":175,"type":22},50,[62,25],"GVHD prevention using a combination of post-transplantation cyclophosphamide in combination with abatacept, vedolizumab and Ruxolitinib in children and young adults with hematoloblastosis after myeloablative conditioning regimen with treosulfan\u002FTBI, etoposide, fludarabine after HSCT from matched unrelated and haploidentical donors",[179,180,181,182,183,184],"Biphenotypic Acute Leukemia","Acute Lymphoblastic Leukemia","Myeloblastic Leukemia","Bilinear Leukemia","Malignant Lymphoma, Non-Hodgkin","Myelodysplastic Syndrome",[186,187,188,189,17,156],"Hematopoetic stem cell transplantation","posttransplant cyclophosphamide","vedolizumab","hematoblastosis","2024-12-24",{"date":192,"type":41},"2025-01-01",{"date":194,"type":41},"2024-07-10",{"date":196,"type":22},"2026-10-10",{"name":47,"class":48},{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":17,"minAge":147,"maxAge":205,"enrollmentInfo":206,"targetDuration":4,"studyType":23,"phases":208,"briefSummary":209,"conditions":210,"keywords":213,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":49},"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","365 Days",{"count":207,"type":22},80,[25],"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.",[211,212],"Acute Lymphoblastic Leukemia, Pediatric","ALL, Infants",[71,33,214,215,216,217,218],"infant","treatment сhemotherapy","Immunotherapy","Blinatumomab","Stemm Cell Transplantation","2024-06-26",{"date":221,"type":41},"2024-06-28",{"date":223,"type":41},"2021-09-23",{"date":225,"type":22},"2030-07-01",{"name":47,"class":48},{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":231,"acronym":232,"eligibilityCriteria":233,"healthyVolunteers":11,"sex":17,"minAge":147,"maxAge":19,"enrollmentInfo":234,"targetDuration":236,"studyType":237,"phases":4,"briefSummary":238,"conditions":239,"keywords":242,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":49},"100538891","abdominal-neuroblastoma-laparoscopic-surgery-risk-factors-stratification-100538891","NCT06296732","Abdominal Neuroblastoma Laparoscopic Surgery Risk Factors Stratification","ANLAP-R","Inclusion Criteria:\n\n1. Patients with neurogenic tumors meeting the criteria of groups I-III:\n\n   Group I\n   * low or moderate risk group according to pilot difficulty scoring system (less than 5 points, see supplementary material);\n   * no IDRF;\n\n   Group II:\n   * low or moderate risk group according to pilot difficulty scoring system (less than 5 points);\n   * patients with any number of IDRFs and without central tumor location and\u002For tumor extension across the midline and\u002For tumor volume (cm3)\u002Fpatient height (m) ratio = 28 or more.\n\n   Group III:\n   * 2 and more IDRF + central tumor location and\u002For tumor extension across the midline;\n   * 2 and more IDRF + tumor volume (cm3)\u002Fpatient height (m) ratio = 28 or more;\n   * 2 and more IDRF + 2 and more other risk factors according to pilot difficulty scoring system;\n   * 1 IDRF + tumor extension across the midline + tumor volume (cm3)\u002Fpatient height (m) ratio = 28 or more.\n2. Age from 0 to 18 years.\n3. Preoperative imaging (abdominal contrast-enhanced computed tomography (CT), performed no later than 14 days before the planned surgery).\n4. Indications for surgery based on the decision of multidisciplinary experts board in centers- participants.\n5. Written voluntary informed consent of the patient and \u002F or his legal representative.\n\nExclusion Criteria:\n\n1. 3 and more IDRF + central tumor location and\u002For tumor extension across the midline and\u002For tumor volume (cm3)\u002Fpatient height (m) ratio = 28 or more.\n2. Severe concomitant pathology, increasing anesthesiologic and surgical risks, via the desicion of the research physician or conclusion by multidisciplinary team in centers- participants.\n3. Tumor volume does not technically allow to provide minimally-invasive surgery, based on the conclusion of multidisciplinary experts board team in centers- participants.\n4. Therapy strategy: observation\n\n   \\-",{"count":235,"type":22},200,"5 Years","OBSERVATIONAL","Surgery plays significant role in treatment of neurogenic tumors, both for benign ganglioneuroma and for high risk neuroblastoma. The world literature has accumulated large experience in laparoscopic surgery for abdominal neuroblastoma. The presence of IDRF (image-defined risk factors) and tumor size (\\>4-7 cm) are considered as common contraindications for minimally invasive surgery in neuroblastoma. However, the recent studies have shown that presence of IDRF is not an absolute contraindication for laparoscopic surgery. This open-label, nonrandomized, observational, phase III evaluates role and weight of different surgical risk factors (including IDRF, tumor size, tumor localization, tumor volume\u002Fpatient height ratio, previous open surgical procedures, previous chemotherapy etc.) in the laparoscopic neuroblastoma resections. The aim of this study is to create novel risk factors scoring system for laparoscopic surgery in abdominal neuroblastoma.",[240,241,29],"Neuroblastoma","Ganglioneuroma",[240,241,29,243,244,245,246,247,248],"Laparoscopic surgery","Minimally-Invasive surgery","IDRF - image-defined risk factors","Risk factors","Difficulty scoring system","Complete resection","2024-05-17",{"date":251,"type":41},"2024-05-20",{"date":253,"type":41},"2023-10-19",{"date":255,"type":22},"2031-11-01",{"name":47,"class":48},{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":11,"sex":17,"minAge":264,"maxAge":91,"enrollmentInfo":265,"targetDuration":4,"studyType":23,"phases":266,"briefSummary":267,"conditions":268,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":49},"100531409","phase-2-ptcy-and-and-ruxolitinib-for-gvhd-prophylaxis-after-hsct-with-thymoglobulin-in-conditioning-regimen-in-patients-with-inborn-errors-of-immunity-100531409","NCT06199427","PTCy and and Ruxolitinib for GVHD Prophylaxis After HSCT With Thymoglobulin in Conditioning Regimen in Patients With Inborn Errors of Immunity","Safety and Efficacy of Cyclophosphamide and Ruxolitinib for Graft-versus-host-disease Prophylaxis After Hematopoietic Stem Cell Transplantation With Thymoglobulin Serotherapy in Conditioning Regimen in Patients With Inborn Errors of Immunity","Inclusion Criteria:\n\n1. Patients aged ≥ 0 months and \\\u003C 21 years\n2. Patients diagnosed with NBS eligible for an allogeneic HSCT\n3. Signed written informed consent signed by a parent or legal guardian\n\nExclusion Criteria:\n\nConcomitant severe somatic disease associated with an additional risk of severe complications","0 Months",{"count":149,"type":22},[62],"The aim of the current study is to evaluate the efficacy of combined regimen of GVHD prophylaxis with thymoglobulin in conditioning regimen and PTCY with ruxolitinib used after HSCT in patients with inborn errors of immunity (IEI)",[269],"Inborn Errors of Immunity","2023-12-28",{"date":272,"type":41},"2024-01-10",{"date":274,"type":41},"2023-11-21",{"date":276,"type":22},"2027-12-31",{"name":47,"class":48},{"id":279,"slug":280,"hasResults":11,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":4,"eligibilityCriteria":284,"healthyVolunteers":11,"sex":17,"minAge":285,"maxAge":91,"enrollmentInfo":286,"targetDuration":4,"studyType":23,"phases":288,"briefSummary":289,"conditions":290,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":292,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":49},"100531364","phase-2-low-dose-treosulfan-based-conditioning-regimen-and-ptcy-in-hsct-for-nijmegen-breakage-syndrome-100531364","NCT06198842","Low Dose Treosulfan Based Conditioning Regimen and PTCy in HSCT for Nijmegen Breakage Syndrome","Clinical Open-label Phase 2 Study of Low Dose Treosulfan Based Conditioning Regimen Efficacy in Hematopoietic Stem Cell Transplantation With Post-transplant Cyclophosphamide for Children Nijmegen Breakage Syndrome","Inclusion Criteria:\n\n1. Patients aged ≥ 3 months and \\\u003C 21 years\n2. Patients diagnosed with NBS eligible for an allogeneic HSCT\n3. Signed written informed consent signed by a parent or legal guardian","3 Months",{"count":287,"type":22},10,[62],"The aim of the current study is to evaluate the safety and efficacy of low dose treosulfan based conditioning regimen in HSCT with post-transplant cyclophosphamide in Nijmegen breakage syndrome",[98],"2023-12-27",{"date":272,"type":41},{"date":294,"type":41},"2023-11-22",{"date":296,"type":22},"2029-01-31",{"name":47,"class":48},{"id":299,"slug":300,"hasResults":11,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":4,"eligibilityCriteria":304,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":305,"targetDuration":4,"studyType":23,"phases":306,"briefSummary":307,"conditions":308,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":49},"100521615","phase-3-induction-chemoimmunotherapy-for-patients-with-high-risk-neuroblastoma-100521615","NCT06071897","Induction Chemoimmunotherapy for Patients With High-risk Neuroblastoma","Introduction of Induction Chemoimmunotherapy Regimen for the Treatment of Pediatric Patients With Stage 4 High-risk Neuroblastoma and Ganglioneuroblastoma Older 18 Months","Inclusion Criteria:\n\n* Signed informed consent\n* Verified diagnosis of neuroblastoma or ganglioneuroblastoma (ICD-10 codes C47.3, C47.4, C47.5, C47.6, C47.8, C47.9, C48, C74.1, C74.9, C76.0, C76.1, C76.2, C76.7, C76.8).\n* High-risk patients in accordance with the risk stratification of to the GPOH-NB2004 protocol with stage 4 according to the International Neuroblastoma Staging System (INSS) from 18 months of life to 18 years.\n* ≥ 70% estimation by Lansky or Karnowski scale at the at the start point of chemoimmunotherapy.\n* Life expectancy ≥ 12 weeks from therapy initiation\n* No signs of drug-induced neuropathy or neuropathic pain.\n* Adequate liver function: alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) activity \\\u003C 5 values of the upper limit of the norm (VGN).\n* Adequate renal function: creatinine clearance or glomerular filtration rate (GFR) \\> 60 ml\u002Fmin\u002F1.73 m2.\n* Coagulogram parameters: prothrombin index (PTI) 70-120%, activated partial thromboplastin time (APTT) \\\u003C 36 s.\n* Absence of clinical signs of heart failure, left ventricular ejection fraction (LVEF) ≥ 55%.\n* Assessment of the function of the respiratory system (saturation on the pulse oximeter \\> 94% without the use of oxygen, there is no respiratory disturbance at rest), the absence of pathology during chest X-ray.\n\nExclusion Criteria:\n\n* Neuroblastoma or ganglioneuroblastoma of the low-risk group or intermediate-risk group, by NB 2004 protocol and disease staging according to INSS (stages 1-3 and 4s without apmplification of MYCN gene, stage 4 in patients under 18 months of age) and high-risk patients with stages 1-3\u002F4s with amplification of MYCN gene.\n* Presence in anamnesis of acute intolerance reactions or contraindications to the main chemotherapeutic, immunobiological agents and any concomitant therapy drugs used within the framework of this clinical trial protocol.\n* Pregnancy due to the high teratogenic activity and toxicity of drugs used in the clinical trial protocol. A pregnancy test is indicated for patients of childbearing age.",{"count":118,"type":22},[25],"The modern strategy of therapy of high-risk neuroblastoma, stage 4, consists of three phases - induction, consolidation and post- consolidation. Still current approaches demonstrates insufficient levels of ORR (overall response rate), OS (overall survival) and EFS (event free survival).\n\nNB-HR-2023 (neuroblastoma high risk) protocol aimed to investigate tolerability and toxicity and potential improvement of ORR, OS and EFS by overcoming of tumor heterogeneous drug resistance using the synergistic interaction of cytostatic and immunobiological agents in the induction. Protocol include the combination of standard chemotherapy (N5 and N6) with anti-GD2 MAB, which is potentially expected to improve outcomes in patients with high-risk neuroblastoma and ganglioneuroblastoma, 4th stage older 18 months.\n\nCurrently, treatment with combinations of cytostatics with immunobiological agents is limited due to the risk of complications, which, nevertheless, is controlled with proper monitoring and concomitant therapy. Still no data about use of combination of standard chemotherapy (N5 and N6) with ch14.18\u002FCHO MAB (dinutuximab beta) in induction in primary patients with neuroblastoma.\n\nProspective, interventional trial include patients with neuroblastoma and ganglioneuroblastoma, 4th stage of the high-risk group older 18 months, who will receive combination of standard induction chemotherapy (N5 and N6) with anti-GD2 MAB. Consolidation and post consolidation chemotherapy courses are not the subjects for analysis.\n\nPatients with high-risk neuroblastoma and ganglioneuroblastoma, stage 4, older 18 months who receive combination of standard induction chemotherapy (N5 and N6) with anti-GD2 MAB at the Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology Delayed surgery (if needed) will be done after the 4th or 6th course of induction therapy and stem cells apheresis after the 2nd-5th course of induction therapy.",[240,29],"2023-10-04",{"date":311,"type":41},"2023-10-10",{"date":313,"type":41},"2023-09-01",{"date":315,"type":22},"2029-09-01",{"name":47,"class":48},{"id":318,"slug":319,"hasResults":11,"nctId":320,"briefTitle":321,"officialTitle":321,"acronym":4,"eligibilityCriteria":322,"healthyVolunteers":11,"sex":323,"minAge":324,"maxAge":19,"enrollmentInfo":325,"targetDuration":4,"studyType":23,"phases":327,"briefSummary":328,"conditions":329,"keywords":331,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":49},"100481451","phase-3-efficacy-and-safety-of-sirolimus-in-children-and-adolescents-with-juvenile-nasopharyngeal-angiofibroma-jna-100481451","NCT05549167","Efficacy and Safety of Sirolimus in Children and Adolescents With Juvenile Nasopharyngeal Angiofibroma (JNA)","Inclusion Criteria:\n\n* Confirmed diagnosis of JNA.\n* Male gender.\n* Age 7-18 years.\n* Signed informed consent of the parents or the official representative for patients under 14 years of age, the patient and the patient's parents for persons from 14 to 18 years of age.\n* Adequate liver and kidney function.\n* Patients with primary JNA\n* Patients with tumor volume according to MRI \\>35 ml. Group A1 (Extended phase:) - patients with decrease or stable tumor volume or an increase in tumor volume \\\u003C 20 %, after 3 months of sirolimus therapy.\n\nGroup A2 (Extended phase:)- patients with an increase in tumor volume\\> 20 % after 3 months of sirolimus therapy or the presence of other indications for surgical treatment, according to the investigator opinion.\n\nHistorical control group - patients with diagnosed primary JNA, received treatment in Dmitry Rogachev's Center in the period from January 1, 2013 to April 15, 2022.\n\n* Group B RECCURRENT JNA, Patients with recurrent JNA after primary surgery, who have not previously received sirolimus therapy.\n* Historical control group - patients with diagnosed recurrent JNA, received treatment in Dmitry Rogachev' s Center in the period from January 1, 2013 to April 15, 2022.\n\nExclusion Criteria:\n\nHypersensitivity to sirolimus or its analogues. The presence of acute or chronic infections, including opportunistic infections.\n\nHepatic and\u002For renal insufficiency. The need for concomitant use of inducers (e.g. rifampicin, rifabutin) or inhibitors (e.g. ketoconazole) of the cytochrome CYP3A4 system Previous therapy with sirolimus or other mTOR inhibitors. Indications to palliative therapy, according to investigator's opinion. Participation in other clinical trials.","MALE","7 Years",{"count":326,"type":22},117,[25],"Juvenile nasopharyngeal angiofibroma (JNA) is a pathologically benign yet locally aggressive and destructive tumor that develops in the choana and nasopharynx. Historical treatment of JNA has included embolization, surgical resection, and radiation. mTOR signaling way demonstrated to be involved in regulation of growth and angiogenesis of JNA. Sirolimus, as mTOR inhibitor, is a potential target JNA therapy.\n\nThe main purpose of the study is to evaluate the efficacy and safety of sirolimus in children and adolescents with primary or recurrent JNA. Efficacy will be estimated based on dynamics of the JNA progression. Historical control group will be used for comparison as standard therapy.\n\nDue to limited experience of sirolimus in JNA in routine practice, study should be conducted in 2 phases: pilot and extended. Decision regarding extended phase will be based on the results of pilot phase.",[330],"Juvenile Nasopharyngeal Angiofibroma",[332,333,334],"Juvenile nasopharyngeal angiofibroma","JNA","sirolimus","2022-09-19",{"date":337,"type":41},"2022-09-22",{"date":339,"type":41},"2022-05-30",{"date":341,"type":22},"2029-12-30",{"name":47,"class":48},{"id":344,"slug":345,"hasResults":11,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":4,"eligibilityCriteria":349,"healthyVolunteers":11,"sex":17,"minAge":147,"maxAge":19,"enrollmentInfo":350,"targetDuration":4,"studyType":23,"phases":352,"briefSummary":354,"conditions":355,"keywords":361,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":49},"100479084","phase-4-b-cell-mature-non-hodgkins-lymphoma-treatment-protocol-in-children-and-adolescents-2021-100479084","NCT05518383","B-cell Mature Non-Hodgkin's Lymphoma Treatment Protocol in Children and Adolescents 2021","B-cell Mature Non-Hodgkin's Lymphoma Treatment Protocol in Children and Adolescents 2021 (B-NHL-M-2021)","Inclusion Criteria:\n\n* Age at diagnosis 0 to 18 years.\n* The diagnosis of Burkitt's lymphoma, Diffuse large B-cell lymphom, primary mediastinal lymphoma, primary CNS lymphoma, B-cell (Burkitt) AL\n* Informed consent of the patient parents (guardians) to be treated\n\nExclusion Criteria:\n\n* previous malignancy, prior organ transplant, HIV infection or AIDS or severe immunodeficiency\n* hypersensitivity to rituximab or to ingredients of other IMPs.\n* no informed consent of the patient parents (guardians) to be treated",{"count":351,"type":22},300,[353],"PHASE4","The aim of the trial is to evaluate the molecular characteristics and MDD\u002FMRD of B-NHL in pediatric patients in order to identify on the one hand the very high risk group and to prescribe them more intensive treatment on the other hand to identify those patients who don't need very aggressive therapy. One more study question is to evaluate the role of PET\u002FCT in assessment of the completeness of remission.\n\nThe following primary study questions are going to be analyzed:\n\n* the effectiveness (event-free survival) in pediatric patients with very limited mature B-NHL (R1 - stage I and II R) of substituting anthracyclines and vincristine by the rituximab without compromising survival rates.\n* the effectiveness (event-free survival) in pediatric patients with limited mature B-NHL (R2 - stage I and II NR) of substituting anthracyclines by the rituximab without compromising survival rates.\n* the effectiveness (event-free survival) in pediatric patients with advanced VHR mature B-NHL (R4 - stages with unfavourable genetics of substituting standard chemotherapy by \"second-line\" block VICI in order to improve results\n\nSecondary study questions will address\n\n* additional parameters for immune reconstitution, lymphocyte subpopulations, immunoglobulin levels, vaccination titers and infection rates\n* kinetics of immune reconstitution after treatment",[356,357,358,359,360],"Non-hodgkin Lymphoma,B Cell","Burkitt Lymphoma","Primary Mediastinal Lymphoma","Primary CNS Lymphoma","Diffuse Large B-cell Lymphoma",[362,363,364,365,366,367,368],"B-cell mature non-Hodgkin's lymphoma","Burkitt's lymphoma","Diffuse large B-cell lymphoma","primary mediastinal lymphoma, primary CNS lymphoma","rituximab","children, adolescents","treatment","2022-08-25",{"date":371,"type":41},"2022-08-26",{"date":373,"type":41},"2022-05-25",{"date":375,"type":22},"2027-05-16",{"name":47,"class":48},""]