Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT04442412
Status:
RECRUITING
Last Update Posted:
2022-08-26
First Post:
2020-05-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prephase Treatment With Prednisone +/- Vitamin D Supplementation Followed by Immunochemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}], 'ancestors': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002762', 'term': 'Cholecalciferol'}], 'ancestors': [{'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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). All 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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 430}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2030-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-23', 'studyFirstSubmitDate': '2020-05-26', 'studyFirstSubmitQcDate': '2020-06-19', 'lastUpdatePostDateStruct': {'date': '2022-08-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Survival', 'timeFrame': 'at the end of treatment - 54 months', 'description': 'Progression-Free Survival'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'at the end of treatment - 54 months', 'description': 'Overall Survival'}, {'measure': 'Event Free Survival', 'timeFrame': 'at the end of treatment - 54 months', 'description': 'Event Free Survival (EFS)'}, {'measure': 'Response rate', 'timeFrame': 'at the end of treatment - 54 months', 'description': 'Response rate'}, {'measure': 'Early death rate', 'timeFrame': 'at the end of treatment - 54 months', 'description': 'Early death rate'}, {'measure': 'Rate of ECOG changes after prephase', 'timeFrame': 'at the end of treatment - 54 months', 'description': 'Rate of ECOG changes after prephase'}, {'measure': 'Rate of patients who maintain 25(OH)VitD levels', 'timeFrame': 'At the beginning of Cycle 2 (each cycle is 21 days)', 'description': 'Rate of patients who maintain 25(OH)VitD levels'}, {'measure': 'Rate of 25(OH)VitD correction (VitD supplementation arm)', 'timeFrame': 'At the beginning of Cycle 2 (each cycle is 21 days)', 'description': 'Rate of 25(OH)VitD correction (VitD supplementation arm)'}, {'measure': 'time-to-deterioration physical functioning and fatigue', 'timeFrame': 'At the beginning of Cycle 2 (each cycle is 21 days)', 'description': 'time-to-deterioration physical functioning and fatigue'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vitamin D', 'prednisone +/- Vitamin D supplementation', 'randomized, open label, phase III'], 'conditions': ['Diffuse Large B-Cell Lymphoma', 'Elderly Patients']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'After the patient signs the written informed consent the patient will enter the screening phase planning baseline assessments and will be randomly allocated with a 1 to 1 ratio to Arm A (Standard arm) or Arm B (Experimental arm).\n\nPatients randomized to Arm A will receive a prephase with oral prednisone (50 mg for 7 days \\[day -6 to day 0\\]) followed by 6 courses of R-CHOP or R-miniCHOP every 21 days.\n\nIf patients randomized to arm A are already on VitD, they are allowed to continue receiving VitD supplementation at a dose that can be considered part of the standard of care and does not exceed the maximum standard VitD dose recommended for general adult and elderly population , up to 10,000 U/week VitD .\n\nIf clinically indicated at treating physician judgement, patients could receive 1 mg of vincristine on the first day of prephase ; in this case vincristine administration in cycle 1 of immunochemotherapy should be skipped, in patients receiving R-miniCHOP; reduced to 1 mg, in patients receiving R-CHOP.\n\nPatients randomized to Arm B will receive a prephase with oral prednisone and a prephase therapy with VitD according to the below reported schedule followed by 6 courses of R-CHOP or R-miniCHOP every 21 days.\n\nSchedule for VitD (Cholecalciferol) supplementation: 25,000 U/day starting on day -6:\n\ndaily loading dose for 7 days if 25 VitD baseline level 20-40 ng/ml daily loading dose for 14 days if 25 VitD baseline level \\< 20 ng/ml followed by weekly maintenance supplementation of 25,000 U for the entire duration of immunochemotherapy (6 courses every 21 days - 18 weeks), regardless of the baseline level of 25 VitD.\n\nIf clinically indicated at treating physician judgement, patients could receive 1 mg of vincristine on the first day of prephase (DAY -6); in this case vincristine administration in cycle 1 of immunochemotherapy should be: skipped, in patients receiving R-miniCHOP; reduced to 1 mg, in patients receiving R-CHOP.\n\nPatients with 25(OH)VitD levels \\<30 ng/ml on d1 cycle 2 will receive and additional loading phase of Cholecalciferol 25,000 U/day for 7 days and then 25,000 U once weekly for the duration of immunochemotherapy.\n\nPatients may continue with VitD supplementation after the end of the immunochemotherapy at a (reduced) standard dose of 25,000 U once a month for up to 2 years from end of immunochemotherapy.\n\nPatients experimenting toxicity leading to a delay in treatment administration \\> 4 weeks will discontinue study treatment and will be addressed to a salvage treatment: these patients will be followed-up for survival until the end of the study.\n\nConsolidation radiotherapy:'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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 / ml;\n10. Adequate hematological counts defined as follows:\n\n * Absolute Neutrophil count \\> 1.5 x 109/L unless due to bone marrow involvement by lymphoma\n * Platelet count ≥ 80.000/mm3 unless due to bone marrow involvement by lymphoma\n11. Adequate renal function defined as follows:\n\n \\- Creatinine ≤ 2 mg/dL, unless secondary to lymphoma\n12. Adequate hepatic function defined as follows:\n\n \\- Bilirubin ≤ 2 mg/dL 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/or BCL6 (double-hit)\n2. Use of VitD supplementation as standard of care at dose higher than 10,000 U/week\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/Hyperphosphatemia)\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/or active systemic infection (viral, bacterial or fungal)\n * Chronic hepatitis B virus or hepatitis C requiring treatment.'}, 'identificationModule': {'nctId': 'NCT04442412', 'acronym': 'FIL_PREVID', 'briefTitle': 'Prephase Treatment With Prednisone +/- Vitamin D Supplementation Followed by Immunochemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Italiana Linfomi - ETS'}, 'officialTitle': 'Prephase Treatment With Prednisone +/- 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.', 'orgStudyIdInfo': {'id': 'FIL_PREVID'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm B (Experimental):', 'description': 'Patients randomized to Arm B will receive a prephase with oral prednisone and a prephase therapy with VitD according to the below reported schedule followed by 6 courses of R-CHOP or R-miniCHOP every 21 days.\n\nSchedule for VitD supplementation: 25,000 U/day starting on day -6:\n\ndaily loading dose for 7 days if 25 VitD baseline level 20-40 ng/ml daily loading dose for 14 days if 25 VitD baseline level \\< 20 ng/ml followed by weekly maintenance supplementation of 25,000 U for the entire duration of immunochemotherapy (6 courses every 21 days - 18 weeks), regardless of the baseline level of 25 VitD.', 'interventionNames': ['Drug: Vitamin D3 (Cholecalciferol)', 'Drug: RCHOP o R-miniCHOP at standard doses']}, {'type': 'OTHER', 'label': 'Arm A (Standard arm)', 'description': 'Patients randomized to Arm A will receive a prephase with oral prednisone followed by 6 courses of R-CHOP or R-miniCHOP every 21 days.\n\nIf patients randomized to arm A are already on VitD, they are allowed to continue receiving VitD supplementation at a dose that can be considered part of the standard of care and does not exceed the maximum standard VitD dose recommended for general adult and elderly population , up to 10,000 U/week VitD', 'interventionNames': ['Drug: RCHOP o R-miniCHOP at standard doses']}], 'interventions': [{'name': 'Vitamin D3 (Cholecalciferol)', 'type': 'DRUG', 'description': '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 (CGA) result, but treatment at reduced doses with R-miniCHOP is highly recommended option for UNFIT and FRAIL patients.', 'armGroupLabels': ['Arm B (Experimental):']}, {'name': 'RCHOP o R-miniCHOP at standard doses', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['Arm A (Standard arm)', 'Arm B (Experimental):']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brescia', 'state': 'BS', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessandra Tucci', 'role': 'CONTACT', 'email': 'alessandra.tucci@ospedalicivili.brescia.it'}, {'name': 'Alessandra Tucci, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'SC Ematologia Spedali Civili', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'zip': '29121', 'city': 'Piacenza', 'state': 'PC', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Annalisa Arcari, MD', 'role': 'CONTACT', 'email': 'a.arcari@ausl.pc.it'}, {'name': 'Annalisa Arcari, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UO Ematologia e CTMO di Piacenza', 'geoPoint': {'lat': 45.05242, 'lon': 9.69342}}, {'city': 'Rionero in Vulture', 'state': 'Piacenza', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuseppe Pietrantuono, MD', 'role': 'CONTACT', 'email': 'ematologia45@alice.it'}, {'name': 'Giuseppe Pietrantuono, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale Oncologico regionale CROB', 'geoPoint': {'lat': 40.92328, 'lon': 15.6711}}, {'zip': '15121', 'city': 'Alessandria', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Manuela Zanni, MD', 'role': 'CONTACT', 'email': 'manuela.zanni@ospedale.al.it'}, {'name': 'Maria Vittoria Sacchi', 'role': 'CONTACT', 'email': 'mariavittoria.sacchi@ospedale.al.it'}, {'name': 'Manuela Zanni, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'A.O. SS. Antonio e Biagio e Cesare Arrigo - S.C. Ematologia', 'geoPoint': {'lat': 44.90924, 'lon': 8.61007}}, {'zip': '60126', 'city': 'Ancona', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Guido Gini', 'role': 'CONTACT', 'email': 'g.gini@ospedaliriuniti.marche.it'}, {'name': 'Alessandra Barucca', 'role': 'CONTACT', 'email': 'alessandra.barucca@gmail.com'}, {'name': 'Guido Gini, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'A.O. Universitaria Ospedali Riuniti - Ospedale Umberto I Di Ancona', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'zip': '15121', 'city': 'Ascoli Piceno', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Piero Galieni, MD', 'role': 'CONTACT', 'email': 'piero.galieni@sanita.marche.it'}, {'name': 'Pietro Galieni, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ascoli Piceno - Ospedale C.e G. Mazzoni - U.O.C. di Ematologia', 'geoPoint': {'lat': 42.85351, 'lon': 13.57395}}, {'city': 'Aviano', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Michele Spina, MD', 'role': 'CONTACT', 'email': 'mspina@cro.it'}, {'name': 'Michele Spina, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Aviano - Centro Riferimento Oncologico - S.O.C. Oncologia Medica A', 'geoPoint': {'lat': 46.07056, 'lon': 12.59472}}, {'city': 'Barletta', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuseppe Tarantini, MD', 'role': 'CONTACT', 'email': 'giuseppetarantini0@gmail.com'}, {'name': 'Giuseppe Tarantini, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Barletta - Ospedale "Monsignor Raffaele Dimiccoli" - Ematologia', 'geoPoint': {'lat': 41.31429, 'lon': 16.28165}}, {'city': 'Bergamo', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Serena Camilla Dalto', 'role': 'CONTACT', 'email': 'serena.dalto@gavazzeni.it'}, {'name': 'Serena Camilla Dalto, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Bergamo - Cliniche Humanitas Gavazzeni - Oncologia - Cliniche Humanitas Gavazzeni', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'city': 'Biella', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Annarita Conconi, MD', 'role': 'CONTACT', 'email': 'annarita.conconi@aslbi.piemonte.it'}, {'name': 'Annarita Conconi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Biella - Ospedale Degli Infermi - S.C. Oncologia', 'geoPoint': {'lat': 45.56304, 'lon': 8.05796}}, {'city': 'Campobasso', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Sergio Storti, MD', 'role': 'CONTACT', 'email': 'sergio.storti@unicatt.it'}, {'name': 'Sergio Storti, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Campobasso - Universitа Cattolica del Sacro Cuore - Ematologia', 'geoPoint': {'lat': 41.55947, 'lon': 14.66737}}, {'city': 'Castelfranco Veneto', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Roberto Sartori, MD', 'role': 'CONTACT', 'email': 'roberto.sartori@iov.veneto.it'}, {'name': 'Roberto Sartori, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Castelfranco Veneto - Ospedale di Castelfranco Veneto - Ematologia', 'geoPoint': {'lat': 45.67146, 'lon': 11.92755}}, {'city': 'Florence', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Benedetta Puccini, MD', 'role': 'CONTACT', 'email': 'puccinib@aou-careggi.toscana.it'}, {'name': 'Benedetta Puccini, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Unità Funzionale di Ematologia AOU Careggi', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'city': 'Frosinone', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Gabriella Tomei, MD', 'role': 'CONTACT', 'email': 'gintomei@gmail.com'}, {'name': 'Gabriella Tomei, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Frosinone - Presidio Ospedaliero F. Spaziani - UOC Ematologia', 'geoPoint': {'lat': 41.63976, 'lon': 13.34109}}, {'city': 'Matera', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Clara Mannarella, MD', 'role': 'CONTACT', 'email': 'clara.mannarella@virgilio.it'}, {'name': 'Clara Mannarella, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Matera - Ospedale Madonna delle Grazie - Ematologia', 'geoPoint': {'lat': 40.66599, 'lon': 16.60463}}, {'city': 'Meldola', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Fabio Augello, MD', 'role': 'CONTACT', 'email': 'accursio.augello@irst.emr.it'}, {'name': 'Fabio Augello, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Meldola - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) - Ematologia', 'geoPoint': {'lat': 44.12775, 'lon': 12.0626}}, {'city': 'Mestre', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Renato Bassan, MD', 'role': 'CONTACT', 'email': 'renato.bassan@aulss3.veneto.it'}, {'name': 'Renato Bassan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mestre - Ospedale Dell Angelo - U.O. Ematologia', 'geoPoint': {'lat': 45.49167, 'lon': 12.24538}}, {'zip': '20162', 'city': 'Milan', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Emanuele Ravano, MD', 'role': 'CONTACT', 'email': 'emanuele.ravano@ospedaleniguarda.it'}, {'name': 'Isabella Ghislandi', 'role': 'CONTACT', 'email': 'isabella.ghislandi@ospedaleniguarda.it'}, {'name': 'Emanuele Ravano, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'SC Ematologia AO Niguarda Cà Granda', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Monza', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Ivana Casaroli, MD', 'role': 'CONTACT', 'email': 'ivanacasaroli@yahoo.it'}, {'name': 'Ivana Casaroli, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Monza - ASST MONZA Ospedale S. Gerardo - Ematologia', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'city': 'Napoli', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Antonello Sica, MD', 'role': 'CONTACT', 'email': 'antonello.sica@fastwebnet.it'}, {'name': 'Antonello Sica, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Napoli - AOU Universitа degli Studi della Campania Luigi Vanvitelli - Oncologia Medica ed Ematologia', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '28100', 'city': 'Novara', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Gianluca Gaidano, MD', 'role': 'CONTACT', 'email': 'gianluca.gaidano@med.uniupo.it', 'phone': '0321/660655'}, {'name': 'Clara Deambrogi', 'role': 'CONTACT', 'email': 'clara.deambrogi@med.uniupo.it'}, {'name': 'Gianluca Gaidano, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Università del Piemonte Orientale - Novara', 'geoPoint': {'lat': 45.44694, 'lon': 8.62118}}, {'city': 'Padua', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Dario Marino, MD', 'role': 'CONTACT', 'email': 'dario.marino@iov.veneto.it'}, {'name': 'Dario Marino, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Padova - I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'city': 'Pagani', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Catello Califano, MD', 'role': 'CONTACT', 'email': 'c.califano@aslsalerno.it'}, {'name': 'Catello Califano, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pagani - Presidio ospedaliero "A. TORTORA" - U.O. Onco-ematologia', 'geoPoint': {'lat': 40.74199, 'lon': 14.61448}}, {'city': 'Palermo', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Caterina Patti, MD', 'role': 'CONTACT', 'email': 'k.patti@villasofia.it'}, {'name': 'Caterina Patti, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Palermo - A.O. Ospedali Riuniti Villa Sofia-Cervello - Divisione di Ematologia', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'city': 'Palermo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Salvatrice Mancuso, MD', 'role': 'CONTACT', 'email': 'salvatrice.mancuso@unipa.it'}, {'name': 'Salvatrice Mancuso, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Palermo - AOU Policlinico Giaccone - Ematologia', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'city': 'Pavia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luca Arcaini, MD', 'role': 'CONTACT', 'email': 'luca.arcaini@unipv.it'}, {'name': 'Luca Arcaini, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UO Ematologia Università - Policlinico San Matteo', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'city': 'Pescara', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Elsa Pennese, MD', 'role': 'CONTACT', 'email': 'elsapennese@gmail.com'}, {'name': 'Stefania Luciani', 'role': 'CONTACT', 'email': 'stefyluciani@gmail.com'}, {'name': 'Elsa Pennese, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pescara - P.O. Spirito Santo di Pescara - UOS Dipartimentale - Centro di diagnosi e Terapia dei linfomi', 'geoPoint': {'lat': 42.4584, 'lon': 14.20283}}, {'city': 'Potenza', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Michele Cimminiello, MD', 'role': 'CONTACT', 'email': 'miki-doc@virgilio.it'}, {'name': 'Michele Ciminiello, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Potenza - AOR San Carlo', 'geoPoint': {'lat': 40.64175, 'lon': 15.80794}}, {'city': 'Ravenna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Monica Tani, MD', 'role': 'CONTACT', 'email': 'monica.tani@auslromagna.it'}, {'name': 'Monica Tani, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UO Ematologia Ospedale Santa Maria delle Croci', 'geoPoint': {'lat': 44.41344, 'lon': 12.20121}}, {'zip': '42123', 'city': 'Reggio Emilia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francesco Merli, MD', 'role': 'CONTACT', 'email': 'merli.francesco@asmn.re.it', 'phone': '0522-296618'}, {'name': 'Caterina Mammi', 'role': 'CONTACT', 'email': 'mammi.caterina@ausl.re.it'}, {'name': 'Francesco Merli, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Reggio Emilia - AO Santa Maria Nuova', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}, {'city': 'Rimini', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Anna Lia Molinari, MD', 'role': 'CONTACT', 'email': 'annalia.molinari@auslromagna.it'}, {'name': 'Anna Lia Molinari, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UO Ematologia - Ospedale degli Infermi', 'geoPoint': {'lat': 44.05755, 'lon': 12.56528}}, {'city': 'Roma', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Michele Bibas, MD', 'role': 'CONTACT', 'email': 'michele.bibas@inmi.it'}, {'name': 'Michele Bibas, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Roma - IRCCS Spallanzani - Servizio di Ematologia in malattie infettive', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Roma', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luigi Rigacci, MD', 'role': 'CONTACT', 'email': 'lrigacci@scamilloforlanini.rm.it'}, {'name': 'Luigi Rigacci, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Roma - Ospedale S. Camillo - Ematologia', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Ombretta Annibali, MD', 'role': 'CONTACT', 'email': 'o.annibali@unicampus.it'}, {'name': 'Ombretta Annibali, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Roma - Policlinico Universitario Campus Bio-Medico - Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapia cellulare', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Roma', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Stefan Hohaus, MD', 'role': 'CONTACT', 'email': 'stefan.hohaus@Unicatt.it'}, {'name': 'Stefan Hohaus, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Università Cattolica S. Cuore, Ematologia', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Roma', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alice Di Rocco, MD', 'role': 'CONTACT', 'email': 'dirocco@bce.uniroma1.it'}, {'name': 'Alice Di Rocco, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Università La Sapienza Ematologia', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Roma', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Agostino Tafuri, MD', 'role': 'CONTACT', 'email': 'agostino.tafuri@ospedalesantandrea.it', 'phone': '0633775113'}, {'name': 'Agostino Tafuri, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "UOC Ematologia - A.O. Sant'Andrea", 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Salerno', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Carmine Selleri, MD', 'role': 'CONTACT', 'email': 'cselleri@unisa.it'}, {'name': 'Carmine Selleri, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Salerno - Ematologia e Trapianti A.O. San Giovanni di Dio e Ruggi D Aragona - U.O. Ematologia', 'geoPoint': {'lat': 40.67545, 'lon': 14.79328}}, {'city': 'San Giovanni Rotondo', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Nicola Cascavilla, MD', 'role': 'CONTACT', 'email': 'n.cascavilla@operapadrepio.it'}, {'name': 'Nicola Cascavilla, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'San Giovanni Rotondo - Casa Sollievo della Sofferenza - U.O. Ematologia', 'geoPoint': {'lat': 41.70643, 'lon': 15.7277}}, {'city': 'Sassari', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Claudio Fozza, MD', 'role': 'CONTACT', 'email': 'cfozza@uniss.it'}, {'name': 'Claudio Fozza, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sassari - AOU di Sassari - Ematologia', 'geoPoint': {'lat': 40.72586, 'lon': 8.55552}}, {'city': 'Sassuolo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Sara Bigliardi, MD', 'role': 'CONTACT', 'email': 's.bigliardi@ausl.mo.it'}, {'name': 'Sara Bigliardi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UOC Medicina Interna MO DH Oncologico', 'geoPoint': {'lat': 44.5432, 'lon': 10.7848}}, {'city': 'Siena', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alberto Fabbri, MD', 'role': 'CONTACT', 'email': 'a.fabbri@ao-siena.toscana.it'}, {'name': 'Cristiana Cafarelli', 'role': 'CONTACT', 'email': 'cristianacafarelli21@gmail.com'}, {'name': 'Alberto Fabbri, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UOC Ematologia, AOU Senese', 'geoPoint': {'lat': 43.31822, 'lon': 11.33064}}, {'city': 'Terni', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Anna Marina Liberati, MD', 'role': 'CONTACT', 'email': 'marina.liberati@unipg.it'}, {'name': 'Anna Marina Liberati, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Univ. Perugia Sede Terni - Oncoematologia', 'geoPoint': {'lat': 42.56335, 'lon': 12.64329}}, {'zip': '10126', 'city': 'Torino', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Federica Cavallo, MD', 'role': 'CONTACT', 'email': 'f.cavallo@unito.it', 'phone': '+39 0116334264'}, {'name': 'Luca Palumbo', 'role': 'CONTACT'}, {'name': 'Federica Cavallo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AOU Citta della Salute e della Scienza di Torino - Ematologia Universitaria', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'city': 'Torino', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Barbara Botto, MD', 'role': 'CONTACT', 'email': 'bbotto@cittadellasalute.to.it'}, {'name': 'Giorgio Priolo', 'role': 'CONTACT'}, {'name': 'Barbara Botto, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'SC. Ematologia A.O. Città della Salute e della Scienza', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'city': 'Torino', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Federica De marco, MD', 'role': 'CONTACT', 'email': 'federica.demarco@aslcittaditorino.it'}, {'name': 'Federica De marco, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Torino - San Giovanni Bosco - ASL Cittа di Torino - SSD di Ematologia e Malattie Trombotiche', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'zip': '34121', 'city': 'Trieste', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francesco Zaja, MD', 'role': 'CONTACT', 'email': 'francesco.zaja@asuits.sanita.fvg.it'}, {'name': 'Marta De Piccoli', 'role': 'CONTACT', 'email': 'martadepiccoli1810@gmail.com'}, {'name': 'Francesco Zaja, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Trieste - Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - SC Ematologia', 'geoPoint': {'lat': 45.64953, 'lon': 13.77678}}, {'city': 'Udine', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Jacopo Olivieri, MD', 'role': 'CONTACT', 'email': 'jacopo.olivieri@hotmail.it'}, {'name': "Cristina D'Odorico", 'role': 'CONTACT', 'email': 'cristina.dodorico@asuiud.sanita.fvg.it'}, {'name': 'Jacopo Olivieri, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Udine - Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - SOC Clinica Ematologica', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}, {'city': 'Vicenza', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Maria Chiara Tisi, MD', 'role': 'CONTACT', 'email': 'mariachiara.tisi@aulss8.veneto.it'}, {'name': 'Maria Chiara Tisi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'ULSS 8 Berica - Ospedale S. Bortolo - Ematologia', 'geoPoint': {'lat': 45.54672, 'lon': 11.5475}}], 'centralContacts': [{'name': 'Lorenza Randi, Dott.ssa', 'role': 'CONTACT', 'email': 'lrandi@filinf.it', 'phone': '0000000000'}, {'name': 'Francesco Merli, Dott.', 'role': 'CONTACT', 'email': 'startup@filinf.it', 'phone': '0000000000'}], 'overallOfficials': [{'name': 'Francesco Merli, Dott.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Reggio Emilia - Azienda Unitа Sanitaria Locale-IRCCS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This is an open-label, multicenter, randomized phase III trial. The study plans to randomize patients with a 1:1 ratio to Arm A (Standard arm) or Arm B (Experimental arm). All 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 (CGA) result, but treatment at reduced doses with R-miniCHOP is highly recommended option for UNFIT and FRAIL patients.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Italiana Linfomi - ETS', 'class': 'OTHER'}, 'collaborators': [{'name': 'GRADE Onlus', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}