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Choice of type of immunochemotherapy will not rely on Comprehensive Geriatric Assessment (CGA) result, but treatment at reduced doses with R-miniCHOP is highly recommended option for UNFIT and FRAIL patients.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"RCHOP o R-miniCHOP at standard doses","Patients on both arms receive pre-treatment with prednisone oral before 6 cycles of 21 days each of immunochemotherapy with RCHOP\n\no R-miniCHOP at standard doses",[16,9],[31],{"name":32,"affiliation":33,"role":34},"Francesco Merli, Dott.","Reggio Emilia - Azienda Unitа Sanitaria Locale-IRCCS","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Lorenza Randi, Dott.ssa","CONTACT","0000000000","lrandi@filinf.it",{"name":32,"role":38,"phone":39,"phoneExt":25,"email":42},"startup@filinf.it",[44,63,78,92,109,127,141,154,167,181,194,207,220,233,246,259,272,285,302,315,328,346,359,372,385,395,408,424,438,451,469,482,495,505,515,525,535,546,559,572,585,598,614,627,644,656,666,683,699],{"facility":45,"status":46,"city":47,"state":48,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"SC Ematologia Spedali Civili","RECRUITING","Brescia","BS","Italy","IT",{"type":52,"coordinates":53},"Point",[54,55],10.21472,45.53558,{"lat":55,"lon":54},[58,61],{"name":59,"role":38,"phone":25,"phoneExt":25,"email":60},"Alessandra Tucci","alessandra.tucci@ospedalicivili.brescia.it",{"name":62,"role":34,"phone":25,"phoneExt":25,"email":25},"Alessandra Tucci, MD",{"facility":64,"status":46,"city":65,"state":66,"zip":67,"country":49,"countryCode":50,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"UO Ematologia e CTMO di Piacenza","Piacenza","PC","29121",{"type":52,"coordinates":69},[70,71],9.69342,45.05242,{"lat":71,"lon":70},[74,77],{"name":75,"role":38,"phone":25,"phoneExt":25,"email":76},"Annalisa Arcari, MD","a.arcari@ausl.pc.it",{"name":75,"role":34,"phone":25,"phoneExt":25,"email":25},{"facility":79,"status":80,"city":81,"state":65,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Ospedale Oncologico regionale CROB","NOT_YET_RECRUITING","Rionero in Vulture",{"type":52,"coordinates":83},[84,85],15.6711,40.92328,{"lat":85,"lon":84},[88,91],{"name":89,"role":38,"phone":25,"phoneExt":25,"email":90},"Giuseppe Pietrantuono, MD","ematologia45@alice.it",{"name":89,"role":34,"phone":25,"phoneExt":25,"email":25},{"facility":93,"status":46,"city":94,"state":25,"zip":95,"country":49,"countryCode":50,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"A.O. 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Mazzoni - U.O.C. di Ematologia","Ascoli Piceno",{"type":52,"coordinates":131},[132,133],13.57395,42.85351,{"lat":133,"lon":132},[136,139],{"name":137,"role":38,"phone":25,"phoneExt":25,"email":138},"Piero Galieni, MD","piero.galieni@sanita.marche.it",{"name":140,"role":34,"phone":25,"phoneExt":25,"email":25},"Pietro Galieni, MD",{"facility":142,"status":46,"city":143,"state":25,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"Aviano - Centro Riferimento Oncologico - S.O.C. 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Cuore, Ematologia",{"type":52,"coordinates":518},[487,488],{"lat":488,"lon":487},[521,524],{"name":522,"role":38,"phone":25,"phoneExt":25,"email":523},"Stefan Hohaus, MD","stefan.hohaus@Unicatt.it",{"name":522,"role":34,"phone":25,"phoneExt":25,"email":25},{"facility":526,"status":80,"city":484,"state":25,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":527,"geoPoint":529,"contacts":530},"Università La Sapienza Ematologia",{"type":52,"coordinates":528},[487,488],{"lat":488,"lon":487},[531,534],{"name":532,"role":38,"phone":25,"phoneExt":25,"email":533},"Alice Di Rocco, MD","dirocco@bce.uniroma1.it",{"name":532,"role":34,"phone":25,"phoneExt":25,"email":25},{"facility":536,"status":80,"city":484,"state":25,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":537,"geoPoint":539,"contacts":540},"UOC Ematologia - A.O. Sant'Andrea",{"type":52,"coordinates":538},[487,488],{"lat":488,"lon":487},[541,545],{"name":542,"role":38,"phone":543,"phoneExt":25,"email":544},"Agostino Tafuri, MD","0633775113","agostino.tafuri@ospedalesantandrea.it",{"name":542,"role":34,"phone":25,"phoneExt":25,"email":25},{"facility":547,"status":46,"city":548,"state":25,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":549,"geoPoint":553,"contacts":554},"Salerno - Ematologia e Trapianti A.O. San Giovanni di Dio e Ruggi D Aragona - U.O. Ematologia","Salerno",{"type":52,"coordinates":550},[551,552],14.79328,40.67545,{"lat":552,"lon":551},[555,558],{"name":556,"role":38,"phone":25,"phoneExt":25,"email":557},"Carmine Selleri, MD","cselleri@unisa.it",{"name":556,"role":34,"phone":25,"phoneExt":25,"email":25},{"facility":560,"status":80,"city":561,"state":25,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":562,"geoPoint":566,"contacts":567},"San Giovanni Rotondo - Casa Sollievo della Sofferenza - U.O. Ematologia","San Giovanni Rotondo",{"type":52,"coordinates":563},[564,565],15.7277,41.70643,{"lat":565,"lon":564},[568,571],{"name":569,"role":38,"phone":25,"phoneExt":25,"email":570},"Nicola Cascavilla, MD","n.cascavilla@operapadrepio.it",{"name":569,"role":34,"phone":25,"phoneExt":25,"email":25},{"facility":573,"status":80,"city":574,"state":25,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":575,"geoPoint":579,"contacts":580},"Sassari - AOU di Sassari - Ematologia","Sassari",{"type":52,"coordinates":576},[577,578],8.55552,40.72586,{"lat":578,"lon":577},[581,584],{"name":582,"role":38,"phone":25,"phoneExt":25,"email":583},"Claudio Fozza, MD","cfozza@uniss.it",{"name":582,"role":34,"phone":25,"phoneExt":25,"email":25},{"facility":586,"status":46,"city":587,"state":25,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":588,"geoPoint":592,"contacts":593},"UOC Medicina Interna MO DH Oncologico","Sassuolo",{"type":52,"coordinates":589},[590,591],10.7848,44.5432,{"lat":591,"lon":590},[594,597],{"name":595,"role":38,"phone":25,"phoneExt":25,"email":596},"Sara Bigliardi, MD","s.bigliardi@ausl.mo.it",{"name":595,"role":34,"phone":25,"phoneExt":25,"email":25},{"facility":599,"status":46,"city":600,"state":25,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":601,"geoPoint":605,"contacts":606},"UOC Ematologia, AOU Senese","Siena",{"type":52,"coordinates":602},[603,604],11.33064,43.31822,{"lat":604,"lon":603},[607,610,613],{"name":608,"role":38,"phone":25,"phoneExt":25,"email":609},"Alberto Fabbri, MD","a.fabbri@ao-siena.toscana.it",{"name":611,"role":38,"phone":25,"phoneExt":25,"email":612},"Cristiana Cafarelli","cristianacafarelli21@gmail.com",{"name":608,"role":34,"phone":25,"phoneExt":25,"email":25},{"facility":615,"status":46,"city":616,"state":25,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":617,"geoPoint":621,"contacts":622},"Univ. Perugia Sede Terni - Oncoematologia","Terni",{"type":52,"coordinates":618},[619,620],12.64329,42.56335,{"lat":620,"lon":619},[623,626],{"name":624,"role":38,"phone":25,"phoneExt":25,"email":625},"Anna Marina Liberati, MD","marina.liberati@unipg.it",{"name":624,"role":34,"phone":25,"phoneExt":25,"email":25},{"facility":628,"status":46,"city":629,"state":25,"zip":630,"country":49,"countryCode":50,"cosmosGeoPoint":631,"geoPoint":635,"contacts":636},"AOU Citta della Salute e della Scienza di Torino - Ematologia Universitaria","Torino","10126",{"type":52,"coordinates":632},[633,634],11.99138,44.88856,{"lat":634,"lon":633},[637,641,643],{"name":638,"role":38,"phone":639,"phoneExt":25,"email":640},"Federica Cavallo, MD","+39 0116334264","f.cavallo@unito.it",{"name":642,"role":38,"phone":25,"phoneExt":25,"email":25},"Luca Palumbo",{"name":638,"role":34,"phone":25,"phoneExt":25,"email":25},{"facility":645,"status":46,"city":629,"state":25,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":646,"geoPoint":648,"contacts":649},"SC. Ematologia A.O. Città della Salute e della Scienza",{"type":52,"coordinates":647},[633,634],{"lat":634,"lon":633},[650,653,655],{"name":651,"role":38,"phone":25,"phoneExt":25,"email":652},"Barbara Botto, MD","bbotto@cittadellasalute.to.it",{"name":654,"role":38,"phone":25,"phoneExt":25,"email":25},"Giorgio Priolo",{"name":651,"role":34,"phone":25,"phoneExt":25,"email":25},{"facility":657,"status":80,"city":629,"state":25,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":658,"geoPoint":660,"contacts":661},"Torino - San Giovanni Bosco - ASL Cittа di Torino - SSD di Ematologia e Malattie Trombotiche",{"type":52,"coordinates":659},[633,634],{"lat":634,"lon":633},[662,665],{"name":663,"role":38,"phone":25,"phoneExt":25,"email":664},"Federica De marco, MD","federica.demarco@aslcittaditorino.it",{"name":663,"role":34,"phone":25,"phoneExt":25,"email":25},{"facility":667,"status":46,"city":668,"state":25,"zip":669,"country":49,"countryCode":50,"cosmosGeoPoint":670,"geoPoint":674,"contacts":675},"Trieste - Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - SC Ematologia","Trieste","34121",{"type":52,"coordinates":671},[672,673],13.77678,45.64953,{"lat":673,"lon":672},[676,679,682],{"name":677,"role":38,"phone":25,"phoneExt":25,"email":678},"Francesco Zaja, MD","francesco.zaja@asuits.sanita.fvg.it",{"name":680,"role":38,"phone":25,"phoneExt":25,"email":681},"Marta De Piccoli","martadepiccoli1810@gmail.com",{"name":677,"role":34,"phone":25,"phoneExt":25,"email":25},{"facility":684,"status":80,"city":685,"state":25,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":686,"geoPoint":690,"contacts":691},"Udine - Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - SOC Clinica Ematologica","Udine",{"type":52,"coordinates":687},[688,689],13.23715,46.0693,{"lat":689,"lon":688},[692,695,698],{"name":693,"role":38,"phone":25,"phoneExt":25,"email":694},"Jacopo Olivieri, MD","jacopo.olivieri@hotmail.it",{"name":696,"role":38,"phone":25,"phoneExt":25,"email":697},"Cristina D'Odorico","cristina.dodorico@asuiud.sanita.fvg.it",{"name":693,"role":34,"phone":25,"phoneExt":25,"email":25},{"facility":700,"status":46,"city":701,"state":25,"zip":25,"country":49,"countryCode":50,"cosmosGeoPoint":702,"geoPoint":706,"contacts":707},"ULSS 8 Berica - Ospedale S. Bortolo - Ematologia","Vicenza",{"type":52,"coordinates":703},[704,705],11.5475,45.54672,{"lat":705,"lon":704},[708,711],{"name":709,"role":38,"phone":25,"phoneExt":25,"email":710},"Maria Chiara Tisi, MD","mariachiara.tisi@aulss8.veneto.it",{"name":709,"role":34,"phone":25,"phoneExt":25,"email":25},{"type":713,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[715],{"name":716,"class":6},"GRADE Onlus","100396462","phase-3-prephase-treatment-with-prednisone---vitamin-d-supplementation-followed-by-immunochemotherapy-100396462",false,"NCT04442412","Prephase Treatment With Prednisone +\u002F- Vitamin D Supplementation Followed by Immunochemotherapy","Prephase Treatment With Prednisone +\u002F- Vitamin D Supplementation Followed by Immunochemotherapy in Elderly Patients With Diffuse Large B-Cell Lymphoma (DLBCL) A Randomized, Open Label, Phase III Study by Fondazione Italiana Linfomi.","FIL_PREVID","Inclusion criteria\n\n1. Histologically documented diagnosis of Diffuse Large B-cell Lymphoma or Follicular grade IIIb lymphoma, as defined in the 2017 edition of the World Health Organization (WHO) classification.\n2. Age ≥ 65 years\n3. Comprehensive Geriatric Assessment performed at baseline, before start of any treatment.\n4. Eastern Cooperative Oncology Group performance status (PS) ≤3\n5. Eligibility for anthracycline containing regimen (R-CHOP or R-miniCHOP)\n6. No previous treatment for DLBCL or Follicular grade IIIb lymphoma\n7. Ann Arbor stage I-IV\n8. At least one site of measurable nodal disease at baseline ≥ 1.5 cm in the longest transverse diameter as determined by CT scan ; or one metabolic active site of disease at baseline FDG-PET scan\n9. Serum basic levels of Vitamin D \\[25 (OH) VitD\\] ≤ 40 ng \u002F ml;\n10. Adequate hematological counts defined as follows:\n\n    * Absolute Neutrophil count \\> 1.5 x 109\u002FL unless due to bone marrow involvement by lymphoma\n    * Platelet count ≥ 80.000\u002Fmm3 unless due to bone marrow involvement by lymphoma\n11. Adequate renal function defined as follows:\n\n    \\- Creatinine ≤ 2 mg\u002FdL, unless secondary to lymphoma\n12. Adequate hepatic function defined as follows:\n\n    \\- Bilirubin ≤ 2 mg\u002FdL unless secondary to lymphoma\n13. LVEF \\> 50% at bidimensionally echocardiogram\n14. Life expectancy ≥ 6 months\n15. Subject understands and voluntarily signs an informed consent form approved by an Independent Ethics Committee , prior to the initiation of any screening or study-specific procedures\n16. Subject must be able to adhere to the study visit schedule and other protocol requirements\n17. Men must agree to use one of the below reported acceptable method of contraception for the duration of the study and for 3 months after receiving the last dose of immunochemotherapy, and to not donate sperm while on study.\n\nExclusion criteria\n\n1. Histological diagnosis different from Diffuse large B-Cell Lymphoma or Follicular grade IIIb lymphoma, including diagnosis of HGBL, with rearrangement of MYC, BCL2 and\u002For BCL6 (double-hit)\n2. Use of VitD supplementation as standard of care at dose higher than 10,000 U\u002Fweek\n3. Suspect or clinical evidence of CNS involvement by lymphoma\n4. Contraindication to the use of rituximab\n5. Contraindication to the use of VitD supplementation (Hypercalcemia\u002FHyperphosphatemia)\n6. Subject has received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, investigational therapy, including targeted small molecule agents within 14 days prior to the first dose of study drug\n7. Significant history of neurologic, psychiatric, endocrinological, metabolic, immunologic, or hepatic disease that would preclude participation in the study or compromise ability to give informed consent\n8. Any history of other active malignancies within 2 years prior to study entry, with the exception of adequately treated in situ carcinoma of the cervix uterine, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin or limited stage surgically removed breast cancer or adequately treated with radiation therapy or limited stage prostate carcinoma surgically removed or adequately treated with radiation therapy or previous malignancy confined and surgically resected with curative intent\n9. Evidence of other clinically significant uncontrolled condition including, but not limited to:\n\n   * Uncontrolled and\u002For active systemic infection (viral, bacterial or fungal)\n   * Chronic hepatitis B virus or hepatitis C requiring treatment.","ALL","65 Years",{"count":728,"type":729},430,"ESTIMATED","INTERVENTIONAL",[732],"PHASE3","This is an open-label, multicenter, randomized phase III trial. The study plans to randomize patients with a 1 to 1 ratio to Arm A (Standard arm) or Arm B (Experimental arm).\n\nAll patients of both arms will receive a prephase with oral prednisone before 6 cycles Q21 of immunochemotherapy with R-CHOP or R-miniCHOP at standard doses; patients in the Experimental arm (Arm B) will receive also a prephase therapy with VitD and a supplementation of VitD during the intere period of immunochemotherapy according to a prefixed schedule. Choice of type of immunochemotherapy will not rely on Comprehensive Geriatric Assessment result, but treatment at reduced doses with R-miniCHOP is highly recommended option for UNFIT and FRAIL patients.",[735,736],"Diffuse Large B-Cell Lymphoma","Elderly Patients",[738,739,740],"Vitamin D","prednisone +\u002F- Vitamin D supplementation","randomized, open label, phase III","2022-08-23",{"date":743,"type":744},"2022-08-26","ACTUAL",{"date":746,"type":744},"2021-03-23",{"date":748,"type":729},"2030-09-01",{"name":5,"class":6},49]