[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mature-b-cell-non-hodgkin-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mature-b-cell-non-hodgkin-lymphoma":62},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"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":27,"conditions":28,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100480268","phase-1-a-study-to-evaluate-glofitamab-monotherapy-and-glofitamab--chemoimmunotherapy-in-pediatric-and-young-adult-participants-with-relapsedrefractory-mature-b-cell-non-hodgkin-lymphoma-100480268",false,"NCT05533775","A Study to Evaluate Glofitamab Monotherapy and Glofitamab + Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed\u002FRefractory Mature B-Cell Non-Hodgkin Lymphoma","A Phase I\u002FII, Open-Label, Single-Arm, Two-Part Trial to Evaluate Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of Glofitamab in Monotherapy and in Combination With Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed\u002FRefractory Mature B-Cell Non-Hodgkin Lymphoma","iMATRIX GLO","Inclusion Criteria:\n\n* Age 6 months to \\\u003C 18 years at the time of signing Informed Consent for Cohort A Part 1 and Cohort B of the study, and age 6 months to \\\u003C 30 years old at the time of signing Informed Consent for Cohort A Part 2 of the study\n* Histologically re-confirmed diagnosis, via tissue biopsy, or bone marrow aspirate, pleural effusion, or ascites, prior to study entry of aggressive mature B-NHL that expresses CD20 (reconfirmed by IHC or flow cytometry if IHC is not possible), including BL, BAL (mature B-cell leukemia FAB L3), DLBCL, and PMBCL, at the time of first R\u002FR disease for Cohort A and second or greater R\u002FR disease for Cohort B\n* Refractory or relapsed disease (i.e., prior treatment was ineffective or intolerable) following first-line standard-of-care chemoimmunotherapy for Cohort A and following at least two prior systemic chemoimmunotherapy regimens and who have exhausted all available established therapies for Cohort B\n* Measurable disease, defined as: At least one bi-dimensionally measurable nodal lesion, defined as \\> 1.5 cm in its longest dimension, or at least one bi dimensionally measurable extranodal lesion, defined as \\> 1.0 cm in its longest dimension; or percentage of bone marrow involvement with lymphoma cells defined by cytomorphological analysis of bone marrow aspirates\n* Adequate performance status, as assessed according to the Lansky or Karnofsky Performance Status scales: Participants \\\u003C 16 years old: Lansky Performance Status ≥ 50%; Participants ≥ 16 years old: Karnofsky Performance Status ≥ 50%\n* Adequate bone marrow, liver, and renal function\n* Negative test results for acute or chronic hepatitis B virus (HBV), hepatitis C virus (HCV)\n* Negative HIV test at screening, with the following exception: Individuals with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy for at least 4 weeks, have a CD4 count ≥200\u002FuL, have an undetectable viral load, and have not had a history of opportunistic infection attributable to AIDS within the last 12 months\n* Negative SARS-CoV-2 antigen or PCR test within 7 days prior to enrollment\n* Participants and\u002For caregivers who are willing and able to complete clinical outcome assessments throughout the study using either paper or interviewer methods\n\nExclusion Criteria:\n\n* Isolated CNS disease of mature B-NHL without systemic involvement, and primary CNS lymphoma\n* Receipt of glofitamab prior to study enrollment\n* Ongoing adverse events from prior anti-cancer therapy that were not resolved to Grade ≤ 1 (exceptions: alopecia, Grade 2 peripheral neuropathy)\n* Grade ≥ 3 adverse events, with the exception of Grade 3 endocrinopathy managed with replacement therapy\n* Participants with active infections which are not resolved prior to Day 1 of Cycle 1\n* Prior solid organ transplantation\n* Known or suspected history of hemophagocytic lymphohistiocytosis (HLH), or chronic active Epstein-Barr viral infection (CAEBV)\n* Active autoimmune disease requiring treatment\n* History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products, except if the participant was able to safely receive it after initial administration (consider consultation with Medical Monitor)\n* History of confirmed progressive multifocal leukoencephalopathy\n* Current or past history of uncontrolled non-malignant CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease\n* Evidence of significant and uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results\n* Major surgery or significant traumatic injury \\\u003C 28 days prior to the obinutuzumab pretreatment infusion (excluding biopsies) or anticipation of the need for major surgery during study treatment\n* Administration of a live, attenuated vaccine within 4 weeks before the start of study treatment (obinutuzumab pretreatment) or at any time during the study treatment period and within 12 months after end of study treatment\n* Participants with any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug","ALL","6 Months","30 Years",{"count":21,"type":22},65,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","The purpose of this study is to evaluate the safety and efficacy of glofitamab, as monotherapy and in combination with a standard chemoimmunotherapy regimen: rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) in pediatric and young adult participants with relapsed and refractory (R\u002FR) mature B-cell non-Hodgkin lymphoma (B-NHL).",[29],"Mature B-Cell Non-Hodgkin Lymphoma",[31,32,33,34],"Relapsed","Refractory","Pediatrics","B-NHL","RECRUITING","2026-07-01",{"date":38,"type":39},"2026-07-02","ACTUAL",{"date":41,"type":39},"2022-11-16",{"date":43,"type":22},"2032-11-30",{"name":45,"class":46},"Hoffmann-La Roche","INDUSTRY",30,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":34,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100605934","phase-2-chemotherapy-with-rituximab-for-aggressive-b-nhl-in-children-and-adolescents-100605934","NCT07168980","Chemotherapy With Rituximab for Aggressive B-NHL in Children and Adolescents","Intensive Chemotherapy Combined With Early, Adequate, and Intensive Use of Rituximab for Aggressive B-NHL in Children and Adolescents","Inclusion Criteria:\n\n* Histology or cytologically confirmed mature B-cell NHL\u002FAL(Burkitt, DLBCL, PMLBL,or aggressive mature B-cell NHL non other specified or specifiable)\n* Able to comply with scheduled follow-up and with management of toxicity\n* Signed informed consent\n\nExclusion Criteria:\n\n* Follicular lymphoma, MALT and nodular marginal zone are not included into this therapeutic study\n* Patients with congenital immunodeficiency, chromosomal breakage syndrome, prior organ transplantation, previous malignancy of any type, or known positive HIV serology.\n* Evidence of pregnancy or lactation period. Past or current anti-cancer treatment except corticosteroids during less than one week.\n\nExclusion Criteria related to Rituximab :\n\n* Tumor cell negative for CD20\n* Prior exposure to rituximab\n* Hepatitis B carrier status history of HBV or positive serology.","18 Years",{"count":57,"type":22},87,[26,59],"PHASE3","The purpose of this study is to test whether intensive chemotherapy combined with early, adequate, and intensive use of Rituximab for aggressive B-NHL in children and adolescents can improve the EFS and OS compared with the historical study CCCG-BNHL-2015.",[62],"Mature B-cell Non-Hodgkin Lymphoma",[64,65,66,67],"mature B-cell non-Hodgkin lymphoma","children","adolescent","rituximab","2026-06-03",{"date":70,"type":39},"2026-06-04",{"date":72,"type":39},"2025-07-01",{"date":74,"type":22},"2030-06-30",{"name":76,"class":77},"Children's Cancer Group, China","NETWORK",1]