[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100458736":3},{"organization":4,"armGroups":7,"interventions":42,"overallOfficials":147,"centralContacts":152,"locations":162,"responsibleParty":201,"collaborators":156,"id":204,"slug":205,"hasResults":206,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":210,"eligibilityCriteria":211,"healthyVolunteers":206,"sex":212,"minAge":213,"maxAge":214,"enrollmentInfo":215,"targetDuration":156,"studyType":218,"phases":219,"briefSummary":221,"conditions":222,"keywords":156,"overallStatus":183,"whyStopped":156,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":234},{"fullName":5,"class":6},"New York Medical College","OTHER",[8,16,28,35],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1a","EXPERIMENTAL","Mature B-cell Non-hodgkin Lymphoma \\[MB NHL\\], GROUP B will receive reduction therapy with dexamethasone, vincristine and cyclophosphamide (DOC), then undergo disease assessment. If tumor reduction ≥ 20%, will get induction 1 and 2 with polatuzumab vedotin, cyclophosphamide, vincristine, methotrexate, rituximab, doxorubicin (Pv-COM3RA25D) 1 and 2, then Consolidation 1 with rituximab, cytarabine, methotrexate (R-CYM) . Patients will undergo disease assessment post Consolidation 1. If no residual disease, they proceed to receive Consolidation 2 with Pv-R-CYM (R-CYM 2).\n\nCohort Ia patients with \\\u003C 20% tumor reduction post DOC will be assigned to Cohort Ib starting at Induction 1. Cohort Ia patients with residual disease post Consolidation 1 will be assigned to Cohort Ib starting at Consolidation 1 polatuzumab vedotin, rituximab, high dose cytarabine, cytarabine, high dose methotrexate, etoposide (Pv-R-CYVE 1).",[13,14,15],"Drug: DOC Group B","Drug: Pv-COMRAD 1 and 2 Group B","Drug: Pv-R-CYM 1 and 2 Group B",{"label":17,"type":10,"description":18,"interventionNames":19},"Cohort 1b","MB NHL, GROUP C will receive reduction therapy with DOC. Patients with \\\u003C 20% tumor reduction will be off protocol. Patients with ≥ 20% tumor reduction get Induction 1 and 2 with cyclophosphamide, doxorubicin, dexamethasone, high dose methotrexate, polatuzumab vedotin, and triple intrathecal chemotherapy (M8A30D CPR) 1 and 2, then Consolidation 1 with Pv-R-CYVE 1. If no residual disease, they get Consolidation 2 (Pv-R-CYVE 2), followed by Maintenance (M) 1 with M8A30D CP, M 2 with Pv-cytarabine\u002Fetoposide, M 3 with cyclophosphamide, doxorubicin, dexamethasone and polatuzumab vedotin (A30D CP), and M 4 with Pv-cytarabine\u002Fetoposide. Cohort Ib patients with CNS disease will receive additional intrathecal chemotherapy and high dose methotrexate during Consolidation.",[20,21,22,23,24,25,26,27],"Drug: DOC Group C","Drug: MAD CPR 1 and 2","Drug: Pv-R CYVE 1 and 2","Drug: Pv-R CYVE-MTX 1 and 2","Drug: MAD CP","Drug: Pv-Cytarabine\u002Fetoposide","Drug: AD CP","Radiation: Involved Site Radiation Therapy",{"label":29,"type":10,"description":30,"interventionNames":31},"Cohort 2a","Classical Hodgkin lymphoma, INTERMEDIATE RISK will receive 2 cycles of brentuximab vedotin (Bv), doxorubicin, vinblastine, dactinomycin, and rituximab (Bv-AVD-R 1 and 2). Response assessment with FDG-PET scan after 2 cycles of Bv-AVD-R. Rapid early responders (RER) will continue therapy with 2 cycles of Bv, vinblastine, dactinomycin, nivolumab, and rituximab (Bv-NVD-R 1 and 2). RERs will not receive radiation therapy. Patients deemed to be Slow Early Responders (SER) after 2 cycles of Bv-AVD-R will continue therapy with 4 cycles of Bv-NVD-R (Bv-NVD-R 1, 2, 3, and 4). Radiation therapy will be given at completion of therapy only for SER patients NOT achieving complete remission at the end of chemoimmunotherapy.",[32,33,34],"Drug: Bv-AVD-R 1 and 2: COHORT IIa","Drug: Bv-NVD-R, Cycle 1-2","Drug: Bv-NVD-R, Cycle 1-4 SER",{"label":36,"type":10,"description":37,"interventionNames":38},"Cohort 2b","COHORT IIb (Classical Hodgkin lymphoma, HIGH RISK) Cohort IIb patients will receive 2 cycles of brentuximab vedotin (Bv), doxorubicin, vinblastine, dactinomycin, and rituximab (Bv-AVD-R 1 and 2). Response assessment will be performed with FDG-PET scan after 2 cycles of Bv-AVD-R. Rapid early responders (RER) will continue therapy with 4 cycles of Bv, vinblastine, dactinomycin, nivolumab, and rituximab (Bv-NVD-R 1, 2, 3, and 4). RERs will not receive radiation therapy. Patients deemed to be Slow Early Responders (SER) after 2 cycles of Bv-AVD-R will receive 2 cycles of Bv, nivolumab, doxorubicin, vinblastine, dactinomycin, and rituximab (Bv-NAVD-R 1 and 2), followed by 4 cycles of Bv, vinblastine, dactinomycin, nivolumab, and rituximab (Bv-NVD-R 1, 2, 3, and 4). Radiation therapy will be given at completion of therapy only for SER patients NOT achieving complete remission at the end of chemoimmunotherapy.",[39,40,41,27],"Drug: Bv-AVD-R","Drug: Bv-NVD-R, Cycle 1-4 RER","Drug: Bv-NAVD-R, Cycle 1-2",[43,50,56,62,68,74,80,86,92,98,104,110,116,122,128,134,140],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"DRUG","DOC Group B","Cyclophosphamide 300 mg x1; dexamethasone x 7; vincristine x1",[9],[49],"Reduction Phase",{"type":44,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"Pv-COMRAD 1 and 2 Group B","polatuzumab vedotin x1; dexamethasone x 5; vincristine x1, cyclophosphamide x 3; doxorubicin x1; methotrexate x; rituximab 2x; ITT x1",[9],[55],"Induction 1 and 2",{"type":44,"name":57,"description":58,"armGroupLabels":59,"otherNames":60},"Pv-R-CYM 1 and 2 Group B","polatuzumab vedotin x 1; methotrexate x 1; rituximab x 1; cytarabine x 5;",[9],[61],"Consolidation 1 and 2",{"type":44,"name":63,"description":64,"armGroupLabels":65,"otherNames":66},"DOC Group C","cyclophosphamide x 1, dexamethasone x 5; vincristine x1; IT triples x 3",[17],[67],"Reduction with IT",{"type":44,"name":69,"description":70,"armGroupLabels":71,"otherNames":72},"MAD CPR 1 and 2","methotrexate x 1; dexamethasone x 5; polatuzumab Vedotin x 1, cyclophosphamide x 3; doxorubicin x 1; rituximab x2; IT triples x 2 in induction 1, IT triples x 2 in induction 2",[17],[73],"Induction 1 and 2 Group C",{"type":44,"name":75,"description":76,"armGroupLabels":77,"otherNames":78},"Pv-R CYVE 1 and 2","Polatuzumab Vedotin x 1; Rituximab x 1; Cytarabine x 5; Etoposide x4;",[17],[79],"Consolidation 1 and 2 Group C CNS Negative",{"type":44,"name":81,"description":82,"armGroupLabels":83,"otherNames":84},"Pv-R CYVE-MTX 1 and 2","Polatuzumab Vedotin x 1; Rituximab x 1; Cytarabine x 5; Etoposide x4; high dose cytarabine x4; high dose methotrexate x 1 (only consolidation 1); IT triples x 2 (only 1 in consolidation 2)",[17],[85],"Consolidation 1 and 2 Group C CNS Positive",{"type":44,"name":87,"description":88,"armGroupLabels":89,"otherNames":90},"MAD CP","dexamethasone x1; polatuzumab vedotin x 1; cyclophosphamide x 2; doxorubicin x 1; high dose methotrexate x 1; IT triples x 1",[17],[91],"Maintenance 1 Group C",{"type":44,"name":93,"description":94,"armGroupLabels":95,"otherNames":96},"Pv-Cytarabine\u002Fetoposide","polatuzumab vedotin x 1; cytarabine x 5; etoposide x 3;",[17],[97],"Maintenance 2, 4 Group C",{"type":44,"name":99,"description":100,"armGroupLabels":101,"otherNames":102},"AD CP","polatuzumab vedotin x 1; cyclophosphamide x2; doxorubicin x 2;",[17],[103],"Maintenance 3 Group C",{"type":44,"name":105,"description":106,"armGroupLabels":107,"otherNames":108},"Bv-AVD-R 1 and 2: COHORT IIa","brentuximab vedotin x 2; doxorubicin x 2; vinblastine x 2; dacarbazine 2x; rituximab x 2",[29],[109],"Intermediate Risk cohort IIa",{"type":44,"name":111,"description":112,"armGroupLabels":113,"otherNames":114},"Bv-NVD-R, Cycle 1-2","brentuximab vedotin x 2; nivolumab x 2; vinblastine x2; dacarbazine x 2; rituximab x 2;",[29],[115],"Cohort IIa Rapid Early Responders",{"type":44,"name":117,"description":118,"armGroupLabels":119,"otherNames":120},"Bv-NVD-R, Cycle 1-4 SER","brentuximab vedotin x 2; nivolumab x 2; vinblastine x 2; rituximab x 2;",[29],[121],"Cohort IIa Slow Early Responders",{"type":44,"name":123,"description":124,"armGroupLabels":125,"otherNames":126},"Bv-AVD-R","Brentuximab vedotin x2; doxorubicin x2; vinblastine x 2; dacarbazine x 2; rituximab x2;",[36],[127],"High-Risk cohort IIb",{"type":44,"name":129,"description":130,"armGroupLabels":131,"otherNames":132},"Bv-NVD-R, Cycle 1-4 RER","brentuximab vedotin x 2; nivolumab x 2; vinblastine x 2; dacarbazine x 2; rituximab x 2;",[36],[133],"cohort IIb Rapid Early Responders",{"type":44,"name":135,"description":136,"armGroupLabels":137,"otherNames":138},"Bv-NAVD-R, Cycle 1-2","brentuximab vedotin x 2; nivolumab x 2; doxorubicin x 2; vinblastine x 2; dacarbazine x 2; rituximab x 2;",[36],[139],"cohort IIb Slow Early Responders",{"type":141,"name":142,"description":143,"armGroupLabels":144,"otherNames":145},"RADIATION","Involved Site Radiation Therapy","21 Gy in 14 fractions of 1.50 Gy per day. The treatment will be given 5 days per week. All fields shall be treated once each day. The total elapsed treatment time will be 2.8 weeks (14 sessions) for each field.",[17,36],[146],"Cohort II ONLY",[148],{"name":149,"affiliation":150,"role":151},"Mitchell Cairo, MD","New York Medical Center","PRINCIPAL_INVESTIGATOR",[153,158],{"name":149,"role":154,"phone":155,"phoneExt":156,"email":157},"CONTACT","9145942150",null,"mitchell_cairo@nymc.edu",{"name":159,"role":154,"phone":160,"phoneExt":156,"email":161},"Lauren Harrison, RN","617-285-7844","lauren_harrison@nymc.edu",[163,181,191],{"facility":164,"status":165,"city":166,"state":167,"zip":168,"country":169,"countryCode":170,"cosmosGeoPoint":171,"geoPoint":176,"contacts":177},"University of Alabama","NOT_YET_RECRUITING","Birmingham","Alabama","35233","United States","US",{"type":172,"coordinates":173},"Point",[174,175],-86.80249,33.52066,{"lat":175,"lon":174},[178],{"name":179,"role":154,"phone":156,"phoneExt":156,"email":180},"Ana Xavier, MD","axavier@peds.uab.edu",{"facility":182,"status":183,"city":184,"state":185,"zip":186,"country":169,"countryCode":170,"cosmosGeoPoint":156,"geoPoint":156,"contacts":187},"University of Flordia","RECRUITING","Gainsville","Florida","32610",[188],{"name":189,"role":154,"phone":156,"phoneExt":156,"email":190},"William Slayton, MD","slaytwb@peds.ufl.edu",{"facility":5,"status":183,"city":192,"state":193,"zip":194,"country":169,"countryCode":170,"cosmosGeoPoint":156,"geoPoint":156,"contacts":195},"Vallhala","New York","10595",[196,199],{"name":197,"role":154,"phone":198,"phoneExt":156,"email":157},"Mitchell S Cairo, MD","914-594-2150",{"name":200,"role":151,"phone":156,"phoneExt":156,"email":156},"Mitchell S. Cairo, MD",{"type":151,"investigatorFullName":202,"investigatorTitle":203,"investigatorAffiliation":5,"oldNameTitle":156,"oldOrganization":156},"Mitchell Cairo","Principal Investigator","100458736","phase-2-chemoradiotherapy-with-targeted-immunotherapy-in-pediatric-lymphoma-100458736",false,"NCT05253495","Chemoradiotherapy With Targeted Immunotherapy in Pediatric Lymphoma","Reducing the Burden of Oncologic Chemoradiotherapy And Radiation Exposure From Diagnostic Imaging by Utilizing Targeted Immunotherapy in Children, Adolescents and Young Adults With Lymphoma","RADICAL","Inclusion Criteria:\n\n* Newly diagnosed patients with histologically or cytologically proven newly diagnosed MB-NHL or cHL according to WHO Classification who meet the following criteria are eligible:\n\nCOHORT I:\n\nBurkitt lymphoma (ICD-O 9687\u002F3) Burkitt-like lymphoma with 11q aberration (ICD-O 9687\u002F3) Diffuse large B-cell lymphoma, NOS (ICD-O 9680\u002F3) High grade B-cell lymphoma (ICD-O 9680\u002F3)\n\nCOHORT Ia: stage III with LDH ≥ 2 ULN OR stage IV (5-24% bone marrow lymphoma infiltration) (GROUP B)61\n\nCOHORT Ib: any CNS involvement and\u002For BM involvement (≥ 25% lymphoma cells) (GROUP C)61 OR patients with less than 20% tumor size reduction post chemotherapy with cyclophosphamide, dexamethasone, vincristine (DOC Reduction for Cohort Ia).\n\nCOHORT II Classical Hodgkin lymphoma (ICD-O 9650\u002F3, 9663\u002F3, 9651\u002F3, 9652\u002F3, 9653\u002F3)\n\nCOHORT IIa: stage I-IIA with bulky ± E, I-IIB no bulky ± E, IIIA ± E (INTERMEDIATE RISK)\n\nCOHORT IIb: stage IIB with bulky ± E, IIIA with bulky ± E, IIIB, IV (HIGH RISK)\n\n* Adequate organ function\n\nExclusion Criteria:\n\n* Primary mediastinal B-cell lymphoma (PMBL)\n* T-cell\u002Fhistiocyte-rich large B-cell lymphoma\n* Gray zone lymphoma\n* Follicular lymphoma\n* Nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL)\n* Posttransplant lymphoproliferative lymphoma (PTLD)","ALL","3 Years","39 Years",{"count":216,"type":217},80,"ESTIMATED","INTERVENTIONAL",[220],"PHASE2","The addition of targeted immunotherapy will be safe and well tolerated and facilitate the reduction of anthracycline exposure while preserving lymphoma disease control in children, adolescents and young adults (CAYA) with mature B-cell non-Hodgkin lymphoma (MB-NHL) and classical Hodgkin lymphoma (cHL).",[223,224],"Non-hodgkin Lymphoma","Hodgkin Lymphoma","2025-06-10",{"date":227,"type":228},"2025-06-13","ACTUAL",{"date":230,"type":228},"2022-02-01",{"date":232,"type":217},"2028-06-30",{"name":5,"class":6},3]