[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Immune Oncology Research Institute\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":107},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,39,60,85],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100507779","phase-2-assessment-of-the-safety-and-efficacy-of-balstilimab-for-the-treatment-of-relapsedrefractory-lymphomas-immonc0001-100507779",false,"NCT05891821","Assessment of the Safety and Efficacy of Balstilimab for the Treatment of Relapsed\u002FRefractory Lymphomas (IMMONC0001)","Inclusion Criteria:\n\n1. Voluntarily agree to participate by giving written informed consent\n2. ≥ 18 years of age\n3. Have a histologically confirmed diagnosis of a relapsed\u002Frefractory classical Hodgkin lymphoma (cHL) or primary mediastinal B-cell lymphoma (PMBCL) for which no standard therapy is available or standard therapy has failed or the patient does not have access to it.\n4. Has a life expectancy of at least 3 months and an ECOG performance status of ≤1 as determined by study Investigator\n5. Patients must have sufficient and adequate formalin-fixed tumor tissue sample available that is not older than 3 years; otherwise, a fresh biopsy is required. Archival tissue or fresh biopsy must be from a site not previously irradiated\n6. Has adequate organ function defined as the following laboratory values within 7 days of C1D1:\n\n   1. Neutrophils ≥ 1500\u002FμL (Must be stable and off any growth factor within 4 weeks of first study treatment administration)\n   2. Platelets ≥ 75 × 103\u002FμL (transfusion to achieve this level is not permitted within 2 weeks of first study treatment administration)\n   3. Hemoglobin ≥ 8.0 g\u002FdL (transfusion to achieve this level is not permitted within 2 weeks of first study treatment administration)\n   4. Creatinine clearance ≥ 30 mL\u002Fmin as measured or calculated per local institutional standards\n   5. AST\u002FALT ≤ 3 × upper limit of normal (ULN)\n   6. Total bilirubin ≤ 1.5 × ULN (except patients with Gilbert syndrome who must have a total bilirubin level of ≤ 3.0 × ULN)\n7. Women of childbearing potential (WOCP) must have a negative serum pregnancy test at Screening (within 7 days before first dose of study drug). Non-childbearing potential is defined as (by other than medical reasons):\n\n   1. ≥ 50 years of age and has not menstruated for greater than 1 year\n   2. Whose status is post hysterectomy, bilateral oophorectomy, or tubal ligation\n   3. WOCP must be willing to use highly effective methods of contraception (defined in the informed consent form \\[ICF\\]) throughout the study, starting with the Screening Visit through 90 days after the last dose of study drug Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.\n8. Male patients with a female partner(s) of childbearing potential must agree to use highly effective contraceptive measures throughout the study starting with the screening visit through 90 days after the last dose of study treatment is received. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner.\n9. Is willing and able to comply with the requirements of the protocol\n\nExclusion Criteria:\n\n1. Has an inadequate period of time prior to first dose of study treatment that is defined as:\n\n   1. Received systemic cytotoxic chemotherapy within 3 weeks before initiation of study treatment\n   2. Received biological therapy or investigational therapy within 4 weeks or 5 circulating halve-lives, whichever is shorter\n   3. Received small molecule\u002Ftyrosine kinase inhibitors within 2 weeks or 5 circulating half-lives, whichever is shorter\n   4. Received radiation therapy within 3 weeks before initiation of study treatment, except for palliative radiation therapy, which can be received 2 weeks prior to initiation of study treatment\n   5. Had major surgery within 4 weeks before initiation of study treatment\n2. Has gone through disease progression after receiving prior therapy with:\n\n   a. Any antibody\u002Fdrug targeting T-cell co-regulatory proteins (immune checkpoints) such as anti-PD-1 and anti-PD-L1 antibodies\n3. Has persisting AEs related to prior immunotherapy of NCI-CTCAE v5.0 Grade ≥ 2 severity.\n4. Is expected to require any other form of systemic or localized antineoplastic therapy while on study (including maintenance therapy with another agent, radiation therapy, and\u002For surgical resection)\n5. Has known allergy or hypersensitivity to any component of balstilimab, any history of anaphylaxis, or uncontrolled asthma\n6. Has active or history of autoimmune disease that requires systemic treatment within 2 years of the start of study drug (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) Note: Patients with autoimmune conditions requiring hormone replacement therapy or topical treatments are eligible.\n7. Patients with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) within 14 days or another immunosuppressive medication within 30 days of the first dose of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses (≤ 10 mg daily prednisone equivalent) are permitted in the absence of active autoimmune disease.\n8. Has had an allogeneic tissue\u002Fsolid organ transplant\n9. Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥ III), or serious uncontrolled cardiac arrhythmia requiring medication.\n\n   a. QTcF (QTc interval corrected using Fridericia's formula) of \\> 480 ms.\n10. Any evidence of current interstitial lung disease (ILD) or pneumonitis, or prior history of ILD or non-infectious pneumonitis requiring glucocorticoids.\n11. Has known untreated hepatitis B\u002Fhepatitis C virus (HBV\u002FHCV) or tuberculosis. Active HBV is defined as a known positive hepatitis B surface antigen result. Active HCV is defined by a known positive hepatitis C antibody result and known quantitative HCV RNA results greater than the lower limits of detection of the assay\n12. Uncontrolled infection with human immunodeficiency virus (HIV). Patients on stable highly active antiretroviral therapy with undetectable viral load and normal CD4 counts for at least 6 months prior to study entry are eligible. Serological testing for HIV at screening is not required.\n13. Has other systemic conditions or organ abnormalities that in the opinion of the Investigator may interfere with the conduct and\u002For interpretation of the current study\n14. Has known psychiatric or substance use disorders that would interfere with cooperation or compromise participation with the requirements of the study\n15. Is legally incapacitated or has limited legal capacity\n16. Is pregnant or breastfeeding\n17. Has received a live\u002Fattenuated vaccine within 14 days of first dose of study treatment and other vaccines within 48 hours of first dose of study treatment\n18. Has other co-morbidities that would alter risk-benefit of providing balstilimab (determined by treating physician's assessment)\n19. Is receiving other therapy that would alter risk-benefit of providing balstilimab (determined by treating physician's assessment)","ALL","18 Years",{"count":18,"type":19},20,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","The goal of this study is to see if the drug balstilimab is safe and effective in participants with relapsed\u002Frefractory lymphomas.\n\nParticipants will receive balstilimab every 3 weeks and their outcomes will be assessed periodically.",[25],"Lymphoma","RECRUITING","2026-06-04",{"date":29,"type":30},"2026-06-08","ACTUAL",{"date":32,"type":30},"2023-09-01",{"date":34,"type":19},"2029-09",{"name":36,"class":37},"Immune Oncology Research Institute","OTHER",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":43,"acronym":4,"eligibilityCriteria":44,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":45,"targetDuration":47,"studyType":48,"phases":4,"briefSummary":49,"conditions":50,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":52,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":59},"100472368","blastic-plasmacytoid-dendritic-cell-neoplasm-bpdcn-international-registry-100472368","NCT05430971","Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) International Registry","Inclusion Criteria:\n\n* Diagnosis of BPDCN\n* Signed informed consent form for prospective patients\n\nExclusion Criteria:\n\n\\-",{"count":46,"type":19},200,"5 Years","OBSERVATIONAL","Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) is a very rare hematologic malignancy. Despite recent advances, at present there is no consensus on the optimal treatment of BPDCN. The optimal therapy of disease remains to be determined, and due to the rarity of cases, there is a need for international collaboration to collect data on BPDCN clinical presentations, diagnostics, treatment regimens and outcomes. Therefore, the objectives of this study are: (1) to build a large database of patients with BPDCN, (2) to investigate the characteristics and outcome of the disease with different treatment regimens, (3) to evaluate prognostic factors, and (4) to generate data-based prospective treatment recommendations.",[51],"Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)",{"date":53,"type":30},"2026-06-05",{"date":55,"type":30},"2022-07-01",{"date":57,"type":19},"2032-07",{"name":36,"class":37},22,{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":67,"targetDuration":47,"studyType":48,"phases":4,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":38},"100571079","cardiac-angiosarcoma-international-registry-100571079","NCT06715579","Cardiac Angiosarcoma International Registry","CAIR","Inclusion Criteria:\n\n* Histological Confirmation: A confirmed diagnosis of cardiac angiosarcoma through histopathological examination, including subtypes such as hemangiosarcoma and epithelioid hemangiosarcoma.\n* Diagnosis Timing: Eligible patients must have been diagnosed between January 2015 and January 2035.\n* Geographical Representation: Participants should be from diverse geographical locations to ensure a comprehensive understanding of the disease across different populations.\n* Treatment Status: Patients who have received any treatment (surgery, chemotherapy, immunotherapy or radiation) for cardiac angiosarcoma may be included to evaluate treatment outcomes.\n* Informed Consent: For prospective patients, informed consent must be obtained before they are included in the registry.\n* Clinical Data Availability: Relevant clinical data, including demographics, tumor characteristics (size, location), treatment regimens, and outcomes, must be available for analysis.\n* Follow-Up Willingness: Participants should be willing to undergo follow-up assessments as part of the registry's data collection efforts.\n\nExclusion Criteria:\n\n* Patients who decline to provide informed consent.\n* Cases where cardiac involvement is secondary to another primary malignancy",{"count":68,"type":19},500,"Primary cardiac angiosarcomas (PCA) are highly aggressive malignant heart tumors arising from the endothelial cells (ECs) lining the blood vessels of the heart and account for approximately 25%-30% of all primary cardiac malignancies. It is considered to be the most fatal and aggressive primary cardiac malignancy. This international registry aims to establish a large multicenter database of patients with cardiac angiosarcoma. Our objectives are:\n\n1. Collect clinical data, including demographics, medical history, treatments, and outcomes, to build a comprehensive database.\n2. Analyze data to evaluate and identify genetic, environmental, or lifestyle risk factors for cardiac angiosarcoma.\n3. Evaluate the effectiveness of various treatments (surgery, chemotherapy, immunotherapy, radiation) to inform best practices.\n4. Develop evidence-based guidelines and recommendations for prevention, diagnosis, treatment, and management based on registry data.",[71],"Cardiac Angiosarcoma",[71,73,74,75,76],"Angiosarcoma","Hemangiosarcoma","Epithelioid Hemangiosarcoma","Primary Cardiac Sarcoma","2026-02-15",{"date":79,"type":30},"2026-02-18",{"date":81,"type":30},"2025-05-01",{"date":83,"type":19},"2035-05",{"name":36,"class":37},{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":15,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":4,"studyType":48,"phases":4,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},"100493963","rare-embryonal-tumors-of-the-central-nervous-system-international-registry-100493963","NCT05711992","Rare Embryonal Tumors of the Central Nervous System: International Registry","Inclusion Criteria:\n\n* Patients diagnosed with rare embryonal tumors of CNS since 01.01.2010:\n\n  * ETMR (including embryonal tumor with abundant neuropil and true rosettes (ETANTR), ependymoblastoma (EBL) and medulloepithelioma (MEPL) which were previously classified as CNS-PNETs)\n  * FOXR2-activated CNS neuroblastoma\n  * cribriform neuroepithelial tumor\n  * CNS tumor with BCOR internal tandem duplication\n  * all patients diagnosed with neuroblastoma and ganglioneuroblastoma with no molecular genetic tests available\n* Patients ≤ 25 years of age\n* Signed informed consent form for prospective patients ≥ 18 years of age\n* Signed parental permission and child assent forms for prospective patients \\\u003C 18 years of age\n\nExclusion Criteria:\n\n• CNS metastases of extracranial embryonal tumors","1 Day","25 Years",{"count":94,"type":19},300,"Central nervous system (CNS) tumors are the most common solid malignancies among children. Although some types of CNS tumors like medulloblastomas and low-grade gliomas are widespread and well-studied, there is a huge number of rare diseases that need further research. This international registry aims to establish a large multicenter database of pediatric and young adult patients with rare embryonal tumors of the central nervous system and describe the clinical presentations, diagnostics, treatment regimens, and outcomes. Embryonal tumors with multilayered rosettes (ETMR), FOXR2-activated CNS neuroblastoma, cribriform neuroepithelial tumor, and CNS tumor with BCOR internal tandem duplication are extremely rare embryonal tumors some of which were first described in the last edition of the World Health Organization (WHO) Classification of Tumors of the Central Nervous System. Objectives of the registry are 1) to evaluate prognostic factors, 2) to identify diagnostic and treatment gaps, 3) to investigate the characteristics and outcome of the disease with different treatment regimens, and 4) to generate data-based prospective diagnostic and treatment recommendations.",[97],"Embryonal Tumor","2025-05-07",{"date":100,"type":30},"2025-05-08",{"date":102,"type":30},"2023-02-01",{"date":104,"type":19},"2033-02",{"name":36,"class":37},11,""]