Ignite Creation Date:
2025-12-24 @ 12:19 PM
Ignite Modification Date:
2026-01-29 @ 8:17 PM
Study NCT ID:
NCT02371161
Status:
UNKNOWN
Last Update Posted:
2018-04-25
First Post:
2015-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II of High-dose Therapy in Elderly Patients With Relapsed Aggressive NHL or Resistant to First Line Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 135}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-24', 'studyFirstSubmitDate': '2015-02-11', 'studyFirstSubmitQcDate': '2015-02-19', 'lastUpdatePostDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event free survival EFS', 'timeFrame': '36 months', 'description': 'Evaluate the toxicity and activity of a therapeutic approach to high doses with stem cell support device (PBSC) in patients aged ≥ 65 and ≤75 years, chemosensitive relapsed or refractory to 1st line therapy in terms of EFS.'}, {'measure': 'Treatment related mortality TRM', 'timeFrame': '100 days from the high doses', 'description': 'Evaluate the toxicity and activity of a therapeutic approach to high doses with stem cell support device (PBSC) in patients aged ≥ 65 and ≤75 years, chemosensitive relapsed or refractory to 1st line therapy in terms of TRM.'}], 'secondaryOutcomes': [{'measure': 'Complete Remission (CR) rate', 'timeFrame': '48 months (at the end of therapy)'}, {'measure': 'Overall Survival (OS)', 'timeFrame': '48 months (at the end of therapy)'}, {'measure': 'Adverse events incidence evaluation (grade III or IV)', 'timeFrame': '48 months (at the end of therapy)', 'description': 'Number of participants with adverse events (grade III or IV)'}, {'measure': 'Quality of Life (QoL)', 'timeFrame': '54 months', 'description': 'Evaluate the quality of life (QoL) before, after therapy rescue and after six months of high-dose therapy through the quality of life questionnaire of European Organization for Research and Treatment of Cancer (EORTC QLQ-C30)'}, {'measure': 'Immunologic evaluation', 'timeFrame': '54 months', 'description': 'Rating basic immunology and 6 months after therapy high doses (lymphocyte subpopulations and Ig subclasses)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Non Hodgkin Lymphoma']}, 'referencesModule': {'references': [{'pmid': '40055982', 'type': 'DERIVED', 'citation': 'Tucci A, Re A, Pagani C, Marcheselli L, Marcheselli R, Malaspina F, Cavallo F, Zilioli VR, Zanni M, Mannina D, Michieli M, Arcari A, Castagna L, Musuraca G, Clerico M, Merli F, Tani M, Re F, Gini G, Rotondo F, Turrini M, Rossi G, Cox MC. A phase 2 study of autologous stem cell transplantation as salvage therapy for older patients with aggressive B-cell lymphoma prospectively evaluated by comprehensive geriatric assessment: the FIL_RECANZ study. Leuk Lymphoma. 2025 Jul;66(7):1284-1292. doi: 10.1080/10428194.2025.2471499. Epub 2025 Mar 8.'}]}, 'descriptionModule': {'briefSummary': 'A phase II prospective, non-randomized study. The study aim is to evaluate the feasibility and activity of high-dose therapy with stem cell in elderly patients with aggressive lymphoma relapsed FIT or resistant to first line therapy.', 'detailedDescription': 'The study aim is to evaluate the toxicity and activity of a therapeutic approach to high doses with support of peripheral blood stem cells (PBSC) in patients aged ≥ 65 and ≤75 years, chemosensitive relapsed or refractory to therapy first line in terms of event free survival (EFS) and treatment related mortality (TRM)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of NHL\n* relapse and refractory pts\n* age ≥ 65 and ≤75\n* ECOG performance status \\<2\n* FIT patients (Instrumental Activity of Daily Living (IADL)=8, Activity of Daily Living (ADL)=6, Cumulative Illness Rating Scale (CIRS) =0 SCORE=3-4, \\<5 SCORE=2 )\n* evaluable disease\n* no RT since 3 week\n* absolute neutrophil count \\>= 1500/mm3 and platelets \\>= 100.000/106L\n* Creatinin \\<= 1.5 mg/dL and clearance \\>40 ml/min/24 h\n* bilirubins \\< =2 mg/dL\n* forced expiratory volume \\>50% - arterial pressure O2 \\>70 mmHg\n* no other neoplastic disease\n* Life expectancy\\> 3 months\n* signed informed consent\n\nExclusion Criteria:\n\n* HBV+ - HCV+ - HIV+\n* NSC involvement - medullar infiltration \\> 20%\n* other chemotherapy or radiotherapy\n* cardiac disease\n* alteration of liver and kidney function\n* infections\n* demented patient\n* no compliance and depressed pts\n* Frail and Unfit pts'}, 'identificationModule': {'nctId': 'NCT02371161', 'briefTitle': 'Phase II of High-dose Therapy in Elderly Patients With Relapsed Aggressive NHL or Resistant to First Line Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Italiana Linfomi - ETS'}, 'officialTitle': 'A Phase II Prospective Study of High-dose Myeloablative Therapy, With Stem Cell Devices Support in Elderly Patients (≥65 and ≤ 75 Years) With Relapsed Aggressive Non-Hodgkin Lymphoma or Resistant to First Line Therapy', 'orgStudyIdInfo': {'id': 'FIL_RecAnz'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'R-DHAP/R-ICE', 'description': 'High-dose myeloablative therapy (R-DHAP or R-ICE) and conditioning therapy (BEAM or FEAM) in elderly patients with relapsed NHL or resistant to firs line therapy', 'interventionNames': ['Drug: R-DHAP/R-ICE']}], 'interventions': [{'name': 'R-DHAP/R-ICE', 'type': 'DRUG', 'otherNames': ['R-DHAP or R-ICE and BEAM or FEAM'], 'description': 'R-DHAP/R-ICE 3 cycles every 21 days:\n\n1. R-DHAP\n\n * Rituximab 375 mg/m2, e.v. day 1\n * Desamethasone 40 mg days 1-4\n * cis-Platino100 mg/m2, day 2 (if ≥70 years 75 mg/m2)\n * Aracytin 2000 mg/m2, e.v. day 3 (if ≥70 years 1500 mg/m2)\n2. R-ICE\n\n * Rituximab 375 mg/m2, e.v. day 1\n * Etoposide 100 mg/mq, e.v. days 1,2,3 (if ≥70 years 75 mg/mq)\n * Ifosfamide with Mesna equidone 5000 mg/mq, day 2 (if ≥70 years 3750 mg/mq)\n * Carboplatino AUC=5, e.v. (max 800 mg/mq), day 2 (if ≥70 years AUC=4)\n\nConditioning BEAM or FEAM', 'armGroupLabels': ['R-DHAP/R-ICE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15121', 'city': 'Alessandria', 'state': 'AL', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Flavia Salvi, MD', 'role': 'CONTACT', 'email': 'fsalvi@ospedale.al.it', 'phone': '0131-206066'}, {'name': 'Flavia Salvi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'A.O. SS.Antonio e Biagio e C. Arrigo', 'geoPoint': {'lat': 44.90924, 'lon': 8.61007}}, {'zip': '60126', 'city': 'Ancona', 'state': 'AN', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Attilio Olivieri, MD', 'role': 'CONTACT', 'email': 'a.olivieri@univpm.it', 'phone': '071-5964226'}, {'name': 'Attilio Olivieri, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedali Riuniti', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'zip': '72100', 'city': 'Brindisi', 'state': 'BR', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Italy', 'facility': 'Ospedale Perrino', 'geoPoint': {'lat': 40.63215, 'lon': 17.93607}}, {'zip': '25123', 'city': 'Brescia', 'state': 'BS', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessandra Tucci, MD', 'role': 'CONTACT', 'email': 'alessandra.tucci@spedalicivili.brescia.it', 'phone': '030-3995438'}, {'name': 'Alessandra Tucci, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Spedali Civili', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'zip': '95123', 'city': 'Catania', 'state': 'CT', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Italy', 'facility': 'Policlinico Vittorio Emanuele', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'zip': '71013', 'city': 'San Giovanni Rotondo', 'state': 'FG', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Italy', 'facility': 'Casa Sollievo della Sofferenza', 'geoPoint': {'lat': 41.70643, 'lon': 15.7277}}, {'zip': '47014', 'city': 'Meldola', 'state': 'Forlì-Cesena', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Gerardo Musuraca', 'role': 'CONTACT', 'email': 'g.musuraca@irst.emr.it', 'phone': '0543-739291'}, {'name': 'Gerardo Musuraca, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IRST Meldola', 'geoPoint': {'lat': 44.12775, 'lon': 12.0626}}, {'zip': '16132', 'city': 'Genova', 'state': 'GE', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Italy', 'facility': 'IRCCS San Martino - IST', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'zip': '62012', 'city': 'Civitanova Marche', 'state': 'MC', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Italy', 'facility': 'ASUR Marche, Area Vasta 3', 'geoPoint': {'lat': 43.30491, 'lon': 13.72068}}, {'zip': '98158', 'city': 'Messina', 'state': 'ME', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Donato Mannina, MD', 'role': 'CONTACT', 'email': 'donamanni@gmail.com', 'phone': '090-3992239'}, {'name': 'Donato Mannina, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AO Riuniti Papardo Piemonte', 'geoPoint': {'lat': 38.19394, 'lon': 15.55256}}, {'zip': '20089', 'city': 'Rozzano', 'state': 'Milano', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luca Castagna, MD', 'role': 'CONTACT', 'email': 'luca.castagna@humanitas.it', 'phone': '02-82244580'}, {'name': 'Luca Castagna, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IRCCS Humanitas', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'zip': '20162', 'city': 'Milan', 'state': 'MI', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Chiara Rusconi, MD', 'role': 'CONTACT', 'email': 'chiara.rusconi@ospedaleniguarda.it', 'phone': '02-64442668'}, {'name': 'Chiara Rusconi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "AO Niguarda Ca' Granda", 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '29100', 'city': 'Piacenza', 'state': 'PC', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Daniele Vallisa, MD', 'role': 'CONTACT', 'email': 'd.vallisa@ausl.pc.it', 'phone': '0523-303719'}, {'name': 'Danilele Vallisa, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale Civile "Guglielmo da Saliceto"', 'geoPoint': {'lat': 45.05242, 'lon': 9.69342}}, {'zip': '33081', 'city': 'Aviano', 'state': 'PN', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Mariagrazia Michieli, MD', 'role': 'CONTACT', 'email': 'mmichieli@cro.it', 'phone': '0434-659601'}, {'name': 'Mariagrazia Michieli, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centro di Riferimento Oncologico', 'geoPoint': {'lat': 46.07056, 'lon': 12.59472}}, {'zip': '43126', 'city': 'Parma', 'state': 'PR', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francesca Re, MD', 'role': 'CONTACT', 'email': 'fre@ao.pr.it', 'phone': '0521-033306'}, {'name': 'Francesca Re, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospaliero Universitaria di Parma', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}, {'zip': '85100', 'city': 'Potenza', 'state': 'PZ', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Italy', 'facility': 'Ospedale San Carlo', 'geoPoint': {'lat': 40.64175, 'lon': 15.80794}}, {'zip': '48100', 'city': 'Ravenna', 'state': 'RA', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Monica Tani, MD', 'role': 'CONTACT', 'email': 'monica.tani@ausl.ra.it', 'phone': '0544-286223'}, {'name': 'Monica Tani, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AUSL di Ravenna', 'geoPoint': {'lat': 44.41344, 'lon': 12.20121}}, {'zip': '89125', 'city': 'Reggio Calabria', 'state': 'RC', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Italy', 'facility': 'A.O. Bianchi - Melacrino - Morelli', 'geoPoint': {'lat': 38.11047, 'lon': 15.66129}}, {'zip': '43123', 'city': 'Reggio Emilia', 'state': 'RE', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francesco Merli, MD', 'role': 'CONTACT', 'email': 'merli.francesco@asmn.re.it', 'phone': '0522-296618'}, {'name': 'Francesco Merli, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Asmn-Irccs', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}, {'zip': '00189', 'city': 'Roma', 'state': 'RM', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Maria Christina Cox, MD', 'role': 'CONTACT', 'email': 'chrisscox@gmail.com', 'phone': '338-2268017'}, {'name': 'Maria Christina Cox, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Policlinico Sant'Andrea", 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '84014', 'city': 'Nocera Inferiore', 'state': 'SA', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Italy', 'facility': 'Ospedale Nocera- Pagani', 'geoPoint': {'lat': 40.7454, 'lon': 14.64542}}, {'zip': '84131', 'city': 'Salerno', 'state': 'SA', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Italy', 'facility': 'AOU San Giovanni e Ruggi', 'geoPoint': {'lat': 40.67545, 'lon': 14.79328}}, {'zip': '10126', 'city': 'Torino', 'state': 'TO', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Federica Cavallo, MD', 'role': 'CONTACT', 'email': 'f.cavallo@unito.it', 'phone': '011-6334301'}, {'name': 'Federica Cavallo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AOU Città della Salute e della Scienza', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'zip': '10128', 'city': 'Torino', 'state': 'TO', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Italy', 'facility': 'Ospedale Mauriziano', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'zip': '05100', 'city': 'Terni', 'state': 'TR', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Italy', 'facility': 'AO Santa Maria', 'geoPoint': {'lat': 42.56335, 'lon': 12.64329}}, {'zip': '13100', 'city': 'Vercelli', 'state': 'VC', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Italy', 'facility': 'Ospedale S.Andrea', 'geoPoint': {'lat': 45.32163, 'lon': 8.41989}}, {'zip': '47923', 'city': 'Rimini', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Anna Lia Molinari', 'role': 'CONTACT', 'email': 'annalia.molinari@auslromagna.it', 'phone': '0541-705423'}, {'name': 'Anna Lia Molinari, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale degli Infermi', 'geoPoint': {'lat': 44.05755, 'lon': 12.56528}}], 'overallOfficials': [{'name': 'Luca Castagna, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Humanitas'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Italiana Linfomi - ETS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}