[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ganglioneuroblastoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ganglioneuroblastoma":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,40,70,111,135,167,190,219],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100582068","phase-2-comparing-123i-mibg-and-18f-mfbg-imaging-in-patients-with-newly-diagnosed-high-risk-neuroblastoma-100582068",false,"NCT06858501","Comparing 123I-MIBG and 18F-MFBG Imaging in Patients With Newly Diagnosed, High Risk Neuroblastoma","Concordance in Response Assessment Incorporating Meta-Iodobenzylguanidine (123I-MIBG) and Meta-[18F]Fluorobenzylguanidine (18F-MFBG, IND#146379, NSC#853868) Imaging in Neuroblastoma","Inclusion Criteria:\n\n* Any age at diagnosis.\n* Patients must have a diagnosis of neuroblastoma or ganglioneuroblastoma (nodular, unfavorable subtype) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites.\n* Patients must have high-risk neuroblastoma defined as one of the following:\n\n  * Any age with International Neuroblastoma Risk Group (INRG) stage L2 or M and MYCN amplification.\n  * Age ≥ 547 days and INRG stage M regardless of biologic features.\n  * Age ≥ 547 days and INRG stage L2 with unfavorable histology.\n* Patients must have newly diagnosed disease.\n* Patients must have either measurable or evaluable disease by INRC.\n* Patients observed or treated with a single cycle of chemotherapy per a low- or intermediate-risk neuroblastoma regimen (e.g. as per ANBL0531, ANBL1232 or similar) for what initially appeared to be non-high-risk disease, but subsequently found to meet high-risk criteria will be eligible. These patients must enroll prior to the start of high-risk therapy.\n* Patients who receive localized emergency radiation to sites of life-threatening or function-threatening disease prior to or immediately after establishment of the definitive diagnosis will be eligible.\n* Patients initially recognized to have high-risk disease must enroll prior to or within the first week after starting high-risk induction chemotherapy.\n* Induction therapy as per a standard high-risk neuroblastoma induction regimen (examples include ANBL1531 arm A, ANBL2131 arm A, or ANBL2131 arm B) must be planned for patients to be eligible for this study.\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events of radiation. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use two effective methods of birth control, including a medically accepted barrier or contraceptive method (e.g., male or female condom) at least 48 hours prior to and following all imaging studies. Abstinence is an acceptable method of birth control.\n* Norepinephrine transporter (NET)-dependent agents: Many medications are known to interfere with uptake of NET-dependent agents. Investigators should use caution when prescribing these medications for patients undergoing procedures on this study. Medications that are known to substantially interfere with uptake of NET-dependent agents should be held if possible, based on patient condition 24 hours prior to each 18F-MFBG scan. These agents can be resumed immediately after each 18F-MFBG scan is completed. Patients who are receiving medications that are known to significantly interfere with uptake of NET-dependent agents (primarily tricyclic antidepressants, psychostimulants, and antihypertensives) and for whom these medications cannot be safely withheld before the start of study procedures will not be eligible.\n* The patient has a known or suspected history of significant allergic reaction or anaphylaxis to any components of the 18F-MFBG or 123I-MIBG imaging agents.\n* Patients who will require sedation or anesthesia only for 18F-MFBG imaging.\n\n  * Note: Patients who need anesthesia will be required to have 18F-MFBG imaging combined with other scans or procedures necessary for clinical care (ex: MRI, bone marrow aspirate\u002Fbiopsies, line placement).\n* Patients will be able to enroll prior to baseline 123I-MIBG imaging. However, patients who have had their baseline standard of care 123I-MIBG imaging prior to enrollment who have known MIBG non-avid disease are not eligible.\n* Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible.","ALL",{"count":18,"type":19},84,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","This phase II trial evaluates whether an investigational scan (18F-MFBG positron emission tomography \\[PET\\]\u002Fcomputed tomography \\[CT\\] or PET\u002Fmagnetic resonance imaging \\[MRI\\]) can accurately detect tumors in patients with newly diagnosed, high-risk neuroblastoma as well as standard of care imaging with 123 I-MIBG. 18F-MFBG is a radioactive diagnostic agent that is injected into a vein and taken up by tumor cells. The cells can then be visualized using PET\u002FCT or PET\u002FMRI scans. A PET scan uses radioactive material injected into the blood to show the internal workings of the body. A CT scan uses x-rays and a computer to produce a 3-dimensional image of the body. MRI uses radiofrequency waves and a strong magnetic field rather than x-rays to provide clear and detailed pictures of internal organs and tissues. Combining PET with CT or MRI may help doctors better understand the extent and the exact location of disease. Diagnostic procedures, such as 18F-MFBG PET\u002FCT or PET\u002FMRI, may detect tumors as well as or better than the current standard imaging with 123 I-MIBG in patients with newly diagnosed, high-risk neuroblastoma.",[25,26,27],"Ganglioneuroblastoma","Ganglioneuroblastoma, Nodular","High Risk Neuroblastoma","NOT_YET_RECRUITING","2026-06-25",{"date":31,"type":32},"2026-06-29","ACTUAL",{"date":34,"type":19},"2026-09-22",{"date":36,"type":19},"2028-12-20",{"name":38,"class":39},"Children's Oncology Group","NETWORK",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":20,"phases":50,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100217799","phase-ii-study-of-proton-radiation-therapy-for-neuroblastoma-100217799","NCT02112617","Phase II Study of Proton Radiation Therapy for Neuroblastoma","Inclusion Criteria:\n\n* Participants must have histologically confirmed neuroblastoma or ganglioneuroblastoma or elevated urinary catecholamine metabolites. If tumor tissue was obtained, pathological review of surgical specimen at the Massachusetts General Hospital or other DF\u002FHCC institution is required, but preliminary report only required prior to enrollment. If no tumor tissue was obtained, urinary catecholamine metabolites are required.\n* Participants do not need to have measurable disease at the time of radiation. Age ≥ 3 and ≤ 25 years at the time of diagnosis because this study evaluates this disease entity in the pediatric population which may differ from the adult population.\n* Life expectancy of greater than 12 months.\n* ECOG performance status ≤2 (Karnofsky ≥60%, Lansky ≥60%, see Appendix A).\n* Diagnostic Imaging MRI and\u002For CT of the area to be treated within 8 weeks of any treatment. Baseline bone marrow biopsy and bone scan (with 99mTc-diphosphonate or MIBG scan (131I-MIBG or 123I-MIBG) from time of original diagnosis is required.\n* Because radiation is known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n* Ability of the patient or the patient's legal guardian to understand and the willingness to sign a written informed consent document.\n* Participants or their legal guardian must sign consent prior to the initiation of radiation therapy.\n\nExclusion Criteria:\n\n* Patients will be ineligible if any prior therapeutic radiation therapy \\> 500 cGy has been delivered.\n* Patients will be ineligible if chemotherapy was completed ≥ 1 year from the planned start date of radiation therapy or if the patient is referred for radiation therapy after a relapse following a regimen with chemotherapy alone.\n* Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.\n* Pregnant females are excluded. Women of childbearing age\u002Fmenstruating must have a negative pregnancy test prior to initiation of radiation therapy.","6 Months","25 Years",{"count":49,"type":19},30,[51],"NA","This research study is evaluating a therapy called proton beam radiation therapy (PBRT) as a possible treatment for neuroblastoma.\n\nNeuroblastoma most commonly occurs in and around the adrenal glands, which are located at the top of the kidneys. However, it can also occur in other areas where groups of nerve cells exist, such as other areas of the abdomen, neck and near the spine.\n\nConventional radiation therapy with photons is used as standard treatment for many patients with neuroblastic tumors. In this research study, the investigators are looking at another type of radiation called proton radiation which is known to spare surrounding tissues and organs from unnecessary radiation. Proton radiation delivers radiation to the area requiring radiation. This may reduce side effects that patients would normally experience with standard radiation therapy or other means of delivering proton radiation therapy.\n\nIn this research study, the investigators are evaluating the effectiveness of using proton radiation delivered to reduce side effects associated with radiation treatment. The investigators will also be assessing the late side effects experienced by participants in each treatment group.",[54,25],"Neuroblastoma",[54,56,25,57],"Childhood neuroblastoma","Pediatric neuroblastoma","RECRUITING","2026-05-04",{"date":61,"type":32},"2026-05-06",{"date":63,"type":4},"2014-06",{"date":65,"type":19},"2028-03",{"name":67,"class":68},"Massachusetts General Hospital","OTHER",1,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":20,"phases":82,"briefSummary":84,"conditions":85,"keywords":89,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":69},"100631561","phase-1-dual-target-gd2b7-h3-car-nk-cells-for-pediatric-relapsed-or-refractory-neuroblastoma-100631561","NCT07502287","Dual-Target GD2\u002FB7-H3 CAR-NK Cells for Pediatric Relapsed or Refractory Neuroblastoma","A Phase 1\u002FPhase 2, Open-Label Study of BiomarkerInformed, Allogeneic Dual-Target GD2\u002FB7-H3 (CD276) CAR-NK Cells in Children and Young Adults With Relapsed or Refractory Neuroblastoma","DUAL-NK-NB","Inclusion Criteria:\n\n* Age 12 months to 21 years at consent\u002Fassent.\n* Histologically confirmed neuroblastoma or ganglioneuroblastoma with relapsed, refractory, progressive, or persistent high-risk disease for which no curative standard option is available.\n* Measurable or evaluable disease according to revised International Neuroblastoma Response Criteria (rINRC), including MIBG-avid disease, CT\u002FMRI-evaluable soft-tissue disease, and\u002For bone marrow disease.\n* Tumor material available for central assessment of GD2 and B7-H3 expression; at least one target must be positive.\n\nGD2 is treated as the core target and B7-H3 as the complementary target for correlative target-prioritization analyses.\n\n* Prior exposure to standard neuroblastoma therapy, including anti-GD2-based therapy, unless contraindicated, unavailable, or declined for a documented medical reason.\n* Lansky or Karnofsky performance score \\>= 50.\n* Life expectancy \\>= 8 weeks.\n* Recovery from clinically significant acute toxicities of prior therapy and protocol-defined washout from chemotherapy, biologics, radiation, and prior cell therapy.\n* Adequate organ function: hematologic, renal, hepatic, cardiac, and pulmonary function considered sufficient by protocoldefined laboratory and clinical thresholds.\n* Negative pregnancy test for patients of childbearing potential and agreement to use effective contraception during the protocol-defined period.\n* Written informed consent from parent\u002Flegal guardian and assent from the participant when appropriate.\n\nExclusion Criteria:\n\n* Active uncontrolled infection, including bacteremia, uncontrolled viral infection, or invasive fungal disease.\n* Pregnancy or breastfeeding.\n* Active grade \\>= 2 graft-versus-host disease, or systemic immunosuppression for treatment\u002Fprevention of graft-versushost disease within the protocol-defined washout period after prior allogeneic transplant.\n* Symptomatic or unstable central nervous system disease requiring urgent medical intervention.\n* Prior genetically modified cellular therapy within the protocol-defined washout window, or unresolved clinically significant toxicity from prior cell therapy.\n* Active autoimmune disease requiring systemic immunosuppressive therapy.\n* Clinically significant uncontrolled cardiovascular, pulmonary, hepatic, renal, or neurologic disorder that would increase study risk.\n* Known hypersensitivity to fludarabine, cyclophosphamide, study-product components, or supportive-care medications required by the protocol.\n* Known uncontrolled HIV infection or uncontrolled hepatitis B or C.\n* Any medical, psychosocial, or logistical condition that, in the investigator's judgment, would make study participation unsafe or would impair protocol adherence.","12 Months","21 Years",{"count":81,"type":19},36,[83,22],"PHASE1","This illustrative Phase 1\u002FPhase 2 study tests allogeneic dual-target GD2\u002FB7-H3 (CD276) CAR-NK cells in children and young adults with relapsed or refractory neuroblastoma. After lymphodepletion, participants receive IV CAR-NK cells;Part A defines the RP2D and Part B estimates preliminary activity",[86,87,88,25],"Relapsed Neuroblastoma","Refractory Neuroblastoma","High-Risk Neuroblastoma",[90,91,92,93,94,95,96,97,98,99,100],"pediatric neuroblastoma","CAR-NK","GD2","B7-H3","CD276","dual-targeting","relapsed\u002Frefractory","allogeneic","solid tumor immunotherapy","cell therapy","biomarkerinformed design","2026-03-25",{"date":103,"type":32},"2026-03-30",{"date":105,"type":32},"2026-03-02",{"date":107,"type":19},"2028-06-17",{"name":109,"class":110},"Beijing Biotech","INDUSTRY",{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":16,"minAge":118,"maxAge":119,"enrollmentInfo":120,"targetDuration":4,"studyType":20,"phases":122,"briefSummary":124,"conditions":125,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},"100295514","phase-3-testing-the-addition-of-131i-mibg-or-lorlatinib-to-intensive-therapy-in-people-with-high-risk-neuroblastoma-nbl-100295514","NCT03126916","Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)","A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or ALK Inhibitor Therapy Added to Intensive Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma (NBL)","Inclusion Criteria:\n\n* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients must be enrolled on ANBL00B1 (NCT00904241) or APEC14B1 (NCT02402244) prior to enrollment on ANBL1531 (NCT03126916)\n* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patient must be \\>= 365 days and =\\\u003C 30 years of age at diagnosis\n* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients must have a diagnosis of neuroblastoma or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites; the following disease groups are eligible:\n\n  * Patients with International Neuroblastoma Risk Group (INRG) stage M disease are eligible if found to have either of the following features:\n\n    * MYCN amplification (\\> 4-fold increase in MYCN signals as compared to reference signals), regardless of additional biologic features; OR\n    * Age \\> 547 days regardless of biologic features\n  * Patients with INRG stage MS disease with MYCN amplification\n  * Patients with INRG stage L2 disease with MYCN amplification\n  * Patients \\> 547 days of age initially diagnosed with INRG stage L1, L2 or MS disease who progressed to stage M without prior chemotherapy may enroll within 4 weeks of progression to stage M\n  * Patients \\>= 365 days of age initially diagnosed with MYCN amplified INRG stage L1 disease who progress to stage M without systemic therapy may enroll within 4 weeks of progression to stage M\n* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients initially recognized to have high-risk disease must have had no prior systemic therapy (other than topotecan\u002Fcyclophosphamide initiated on an emergent basis and within allowed timing); patients observed or treated with a single cycle of chemotherapy per a low or intermediate risk neuroblastoma regimen (e.g., as per ANBL0531, ANBL1232 or similar) for what initially appeared to be non-high risk disease but subsequently found to meet the criteria will also be eligible; patients who receive localized emergency radiation to sites of life-threatening or function-threatening disease prior to or immediately after establishment of the definitive diagnosis will be eligible\n* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Creatinine clearance or radioisotope glomerular filtration rate (GFR) \\>= 70 mL\u002Fmin\u002F1.73 m\\^2 or a serum creatinine based on age\u002Fsex as follows:\n\n  * 1 to \\\u003C 2 years: male = 0.6; female = 0.6\n  * 2 to \\\u003C 6 years: male = 0.8; female = 0.8\n  * 6 to \\\u003C 10 years: male = 1; female = 1\n  * 10 to \\\u003C 13 years: male = 1.2; female = 1.2\n  * 13 to \\\u003C 16 years: male = 1.5; female = 1.4\n  * \\>= 16 years: male = 1.7; female = 1.4\n* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN) for age, and\n* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \\[ALT\\]) \\\u003C 10 x ULN; for the purposes of this study, ULN for SGPT (ALT) is 45\n* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Shortening fraction of \\>= 27% by echocardiogram, or ejection fraction of \\> 50% by echocardiogram or radionuclide angiogram\n* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: No known contraindication to peripheral blood stem cell (PBSC) collection; examples of contraindications might be a weight or size less than the collecting institution finds feasible, or a physical condition that would limit the ability of the child to undergo apheresis catheter placement (if necessary) and\u002For the apheresis procedure\n* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): See ANBL2131 (NCT06172296) protocol for eligible high-risk neuroblastoma diagnoses\n* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): In addition, all patients transferring from ANBL2131 (NCT06172296) to ANBL1531 (NCT03126916) Arm E must have tumors with an ALK aberration\n* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Given the lack of data with lorlatinib in infant populations, patients transferring from ANBL2131 (NCT06172296) to ANBL1531 (NCT03126916) must be \\> 1 year of age at time of transfer to ANBL1531 (NCT03126916). Patients \\\u003C 1 year of age found to have a qualifying ALK alteration as part of ANBL2131 (NCT06172296) may continue to participate in ANBL2131 (NCT06172296)\n* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients initially recognized to have high-risk disease must have received no more than one cycle of topotecan\u002Fcyclophosphamide either after enrollment to ANBL2131 (NCT06172296) or started emergently prior to enrollment to ANBL2131 (NCT06172296)\n* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients may have received up to one cycle of intermediate risk chemotherapy prior to initial enrollment to ANBL2131 (NCT06172296)\n* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients may have received localized emergency radiation to sites of life-threatening or function-threatening disease prior to or immediately after establishment of the definitive diagnosis\n* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): In order to facilitate patient transfer and ensure timely distribution of lorlatinib, there are no blood count requirements to meet at time of transfer from ANBL2131 (NCT06172296) to ANBL1531 ((NCT03126916) Arm E. Note the blood count criteria that must be met prior to start of Induction cycle 2 on Arm E. Lorlatinib therapy should start no sooner than day 1 of Induction cycle 2\n* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): No known irreversible grade 2 or greater atrioventricular (AV) block\n* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Due the potential psychiatric risks from lorlatinib, patients should not have a personal history of a serious psychiatric disorder requiring pharmacologic intervention or severe enough to be considered life-threatening\n* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): No known contraindication to PBSC collection. Examples of contraindications might be a weight or size less than the collecting institution deems feasible, or a physical condition that would limit the ability of the child to undergo apheresis catheter placement (if necessary) and\u002For the apheresis procedure\n\nExclusion Criteria:\n\n* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients with INRG stage L2 tumors without amplification of MYCN regardless of tumor histology (may meet criteria for high risk classification but are not eligible for this trial)\n* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients with bone marrow failure syndromes\n* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients for whom targeted radiopharmaceutical therapy would be contraindicated due to underlying medical disorders\n* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs; a pregnancy test is required for female patients of childbearing potential\n* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Lactating females who plan to breastfeed their infants\n* FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation\n* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients who have previously received treatment with lorlatinib or other ALK inhibitor\n* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients who have undergone treatment arm randomization callback or started induction cycle 2 on ANBL2131 (NCT06172296)\n* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients who have an INRG Stage L2 tumor without amplification of MYCN regardless of tumor histology (may meet criteria for high risk classification but are not eligible for this trial)\n* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Patients with bone marrow failure syndromes\n* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential\n* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Lactating females who plan to breastfeed their infants\n* PATIENTS WITH TUMORS HARBORING ALK ALTERATIONS TRANSFERRING TO ANBL1531 (NCT03126916) ARM E FROM ANBL2131 (NCT06172296) (EFFECTIVE WITH AMENDMENT 13C): Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation","365 Days","30 Years",{"count":121,"type":19},750,[123],"PHASE3","This phase III trial studies iobenguane I-131 or lorlatinib and standard therapy in treating younger patients with newly-diagnosed high-risk neuroblastoma or ganglioneuroblastoma. Radioactive drugs, such as iobenguane I-131, may carry radiation directly to tumor cells and not harm normal cells. Lorlatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving iobenguane I-131 or lorlatinib and standard therapy may work better compared to lorlatinib and standard therapy alone in treating younger patients with neuroblastoma or ganglioneuroblastoma.",[25,26,54],"2026-02-24",{"date":128,"type":32},"2026-02-27",{"date":130,"type":32},"2018-05-14",{"date":132,"type":19},"2030-09-30",{"name":38,"class":39},162,{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":16,"minAge":143,"maxAge":144,"enrollmentInfo":145,"targetDuration":4,"studyType":20,"phases":147,"briefSummary":148,"conditions":149,"keywords":151,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":69},"100621818","phase-3-chemoimmunotherapy-combined-with-autologous-nk-cell-therapy-for-pediatric-patients-with-refractory-and-relapsed-high-risk-neuroblastoma-and-ganglioneuroblastoma-100621818","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.","18 Months","18 Years",{"count":146,"type":19},5,[123],"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.",[150,25],"Neuroblastoma (NB)",[152,153,154,155,156,157],"Refractory\u002Frelapsed neuroblastoma","ganglioneuroblastoma","children","autologous NK cells","chemoimmunotherapy","dinutuximab beta","2026-01-21",{"date":160,"type":32},"2026-01-29",{"date":162,"type":32},"2025-11-19",{"date":164,"type":19},"2028-11-19",{"name":166,"class":68},"Federal Research Institute of Pediatric Hematology, Oncology and Immunology",{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":171,"acronym":172,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":20,"phases":176,"briefSummary":177,"conditions":178,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":189},"100454087","siopen-bioportal-an-international-registry-linked-to-a-virtual-biobank-for-patients-with-peripheral-neuroblastic-tumours-100454087","NCT05192980","SIOPEN BIOPORTAL, An International Registry Linked to a Virtual Biobank for Patients With Peripheral Neuroblastic Tumours","BIOPORTAL","Inclusion Criteria:\n\nI-1. Patients with PNT: ganglioneuroma or ganglioneuroblastoma or neuroblastoma, I-2. At the time of initial diagnosis of neuroblastic tumour, or at relapse\u002Fprogression if not yet registered I-3. Written patient informed consent, or parents or legal representative written informed consent and assent of the child, adolescent or young adult\n\nNon-Inclusion Criteria:\n\nR-1. (Adult) Patients with olfactory neuroblastoma R-2. Central nervous system (CNS) neuroblastoma (as per the WHO classification)",{"count":175,"type":19},600,[51],"The SIOPEN BIOPORTAL is a prospective non-therapeutic multi-centre international study aimed at developing an international Registry linked to a Virtual Biobank for all the patients with peripheral neuroblastic tumor within countries of the SIOPEN network. The overall aim of this study is to provide a GDPR-compliant framework to collect basic clinical annotations, biological and genetic features and information about the location on biospecimens for all the patients with a peripheral neuroblastic tumor including neuroblastoma, ganglioneuroblastoma and ganglioneuroma in the SIOPEN network.\n\nThis study will support data and sample management and intensify cross-borders data and sample sharing fostering translational and clinical research. The post-hoc hypothesis formulated based on the data generated in this study will be used as statistical basis for future precision medicine programs based on improved biological characterization, patient stratification and therapeutic management.",[54,25,179],"Ganglioneuroma","2025-07-17",{"date":182,"type":32},"2025-07-22",{"date":184,"type":32},"2023-11-02",{"date":186,"type":19},"2038-11-02",{"name":188,"class":68},"Institut Curie",38,{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":194,"acronym":195,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":16,"minAge":197,"maxAge":144,"enrollmentInfo":198,"targetDuration":200,"studyType":201,"phases":4,"briefSummary":202,"conditions":203,"keywords":204,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":69},"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   \\-","1 Day",{"count":199,"type":19},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.",[54,179,25],[54,179,25,205,206,207,208,209,210],"Laparoscopic surgery","Minimally-Invasive surgery","IDRF - image-defined risk factors","Risk factors","Difficulty scoring system","Complete resection","2024-05-17",{"date":213,"type":32},"2024-05-20",{"date":215,"type":32},"2023-10-19",{"date":217,"type":19},"2031-11-01",{"name":166,"class":68},{"id":220,"slug":221,"hasResults":11,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":4,"eligibilityCriteria":225,"healthyVolunteers":11,"sex":16,"minAge":143,"maxAge":144,"enrollmentInfo":226,"targetDuration":4,"studyType":20,"phases":228,"briefSummary":229,"conditions":230,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":69},"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":227,"type":19},15,[123],"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.",[54,25],"2023-10-04",{"date":233,"type":32},"2023-10-10",{"date":235,"type":32},"2023-09-01",{"date":237,"type":19},"2029-09-01",{"name":166,"class":68}]