Ignite Creation Date:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2026-01-04 @ 5:27 AM
Study NCT ID:
NCT02744768
Status:
UNKNOWN
Last Update Posted:
2018-03-22
First Post:
2016-04-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
D-ALBA Frontline Sequential Dasatinib and Blinatumomab in Adult Philadelphia Positive Acute Lymphoblastic Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069439', 'term': 'Dasatinib'}, {'id': 'C510808', 'term': 'blinatumomab'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-12-09', 'size': 390725, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-03-19T10:57', 'hasProtocol': False}, {'date': '2016-11-09', 'size': 2347132, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-03-21T05:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-21', 'studyFirstSubmitDate': '2016-04-11', 'studyFirstSubmitQcDate': '2016-04-18', 'lastUpdatePostDateStruct': {'date': '2018-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients who achieve Minimal Residual Disease (MRD) negativity upon treatment', 'timeFrame': 'After 11 months from study entry', 'description': 'In particular, after 2 cycles of blinatumomab. Minimal Residual Disease (MRD) negativity is intended as Complete Molecular Remission (CMR)'}], 'secondaryOutcomes': [{'measure': 'Number of patients completing the 2 cycles of blinatumomab and alive in first complete hematologic remission (CHR)', 'timeFrame': 'From day +85 at 12 months'}, {'measure': 'Number of patients at Complete Molecular Response (CMR)', 'timeFrame': 'At day +22, +45, +57 and +85 from study entry'}, {'measure': 'Number of months of the CMR', 'timeFrame': 'At 12 and 24 months'}, {'measure': 'Number of patients in Overall Survival (OS)', 'timeFrame': 'At 12 and 24 months'}, {'measure': 'Number of grade >3 adverse events', 'timeFrame': 'At 12 and 24 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Lymphoblastic Leukemia, adult, dasatinib, blinatumomab'], 'conditions': ['Acute Lymphoblastic Leukemia']}, 'referencesModule': {'references': [{'pmid': '38127722', 'type': 'DERIVED', 'citation': 'Foa R, Bassan R, Elia L, Piciocchi A, Soddu S, Messina M, Ferrara F, Lunghi M, Mule A, Bonifacio M, Fracchiolla N, Salutari P, Fazi P, Guarini A, Rambaldi A, Chiaretti S. Long-Term Results of the Dasatinib-Blinatumomab Protocol for Adult Philadelphia-Positive ALL. J Clin Oncol. 2024 Mar 10;42(8):881-885. doi: 10.1200/JCO.23.01075. Epub 2023 Dec 21.'}, {'pmid': '33085860', 'type': 'DERIVED', 'citation': 'Foa R, Bassan R, Vitale A, Elia L, Piciocchi A, Puzzolo MC, Canichella M, Viero P, Ferrara F, Lunghi M, Fabbiano F, Bonifacio M, Fracchiolla N, Di Bartolomeo P, Mancino A, De Propris MS, Vignetti M, Guarini A, Rambaldi A, Chiaretti S; GIMEMA Investigators. Dasatinib-Blinatumomab for Ph-Positive Acute Lymphoblastic Leukemia in Adults. N Engl J Med. 2020 Oct 22;383(17):1613-1623. doi: 10.1056/NEJMoa2016272.'}], 'seeAlsoLinks': [{'url': 'http://www.gimema.it', 'label': 'GIMEMA Foundation website'}]}, 'descriptionModule': {'briefSummary': 'This study aims at exploring the activity of a frontline approach based on dasatinib plus steroids administration as induction treatment, followed by the infusion of Blinatumomab, in adult Ph+ ALL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed adult B-precursor Ph+ ALL patients.\n* Age greater or equal to18 years,\n* Signed written informed consent according to ICH/EU/GCP and national local laws.\n* ECOG Performance Status 0 or 1 and/or WHO performance status less or equal to 2.\n* Renal and hepatic function as defined below:\n\n * AST (GOT), ALT (GPT), and AP \\<2 x upper limit of normal (ULN).\n * Total bilirubin \\<1.5 x ULN.\n * Creatinine clearance equal or greater than 50 mL/min.\n* Pancreatic function as defined below:\n\n * Serum amylase less or equal to 1.5 x ULN\n * Serum lipase less or equal to1.5 x ULN.\n* Normal cardiac function.\n* Negative HIV test, negative HBV DNA and HCV RNA.\n* Negative pregnancy test in women of childbearing potential.\n* Bone marrow specimen from primary diagnosis available.\n\nExclusion Criteria:\n\n* History of or current relevant CNS pathology (current ≥grade 2 epilepsy, seizure, paresis, aphasia, clinically relevant apoplexia, severe brain injuries, dementia, Parkinson\'s disease, organic brain syndrome, psychosis).\n* Impaired cardiac function, including any one of the following:\n\n * LVEF \\<45% as determined by MUGA scan or echocardiogram.\n * Complete left bundle branch block.\n * Use of a cardiac pacemaker.\n * ST depression of \\>1mm in 2 or more leads and/or T wave inversions in 2 or more contiguous leads.\n * Congenital long QT syndrome.\n * History of or presence of significant ventricular or atrial arrhythmia.\n * Clinically significant resting bradycardia (\\<50 beats per minute).\n * QTc \\>450 msec on screening ECG (using the QTcF formula).\n * Right bundle branch block plus left anterior hemiblock, bifascicular block.\n * Myocardial infarction within 3 months prior to starting Dasatinib.\n * Angina pectoris.\n* Other clinically significant heart disease (e.g., congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen).\n* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of Dasatinib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).\n* History of or current autoimmune disease.\n* Systemic cancer chemotherapy within 2 weeks prior to study.\n* Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation.\n* Active malignancy other than ALL with the exception of basal cell or squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix.\n* Active infection, any other concurrent disease or medical conditions that are deemed to interfere with the conduct of the study as judged by the investigator.\n* Nursing women or women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least 3 months thereafter or male patients not willing to ensure effective contraception during participation in the study and at least three months thereafter.'}, 'identificationModule': {'nctId': 'NCT02744768', 'briefTitle': 'D-ALBA Frontline Sequential Dasatinib and Blinatumomab in Adult Philadelphia Positive Acute Lymphoblastic Leukemia', 'organization': {'class': 'OTHER', 'fullName': "Gruppo Italiano Malattie EMatologiche dell'Adulto"}, 'officialTitle': 'D-ALBA Front-Line Sequential Treatment of Adult Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia (ALL) Patients With Dasatinib and the Bispecific Monoclonal Antibody Blinatumomab', 'orgStudyIdInfo': {'id': 'LAL2116'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Adult Ph+ ALL (≥18 years old, with no upper age limit) patients will begin treatment with Dasatinib, 140 mg/day, from day 1 to day +84. Prednisone (PDN) will be administered from day -6 to day +0 (during which the presence of the BCR/ABL1 alteration will be established), at escalating doses up to 60 mg/m2; PDN will be continued up to day +24 and progressively tapered up to day +31.\n\nHLA typing will be performed immediately after the diagnosis for eligible patients.\n\nMRD will be evaluated by RT-PCR at fixed time points (days +22, +45, +57) during the induction and at day +85, the latter for molecular response evaluation.', 'interventionNames': ['Drug: Dasatinib', 'Drug: Blinatumomab']}], 'interventions': [{'name': 'Dasatinib', 'type': 'DRUG', 'description': 'Adult Ph+ ALL (≥18 years old, with no upper age limit) patients will begin treatment with Dasatinib, 140 mg/day, from day 1 to day +84.', 'armGroupLabels': ['Treatment']}, {'name': 'Blinatumomab', 'type': 'DRUG', 'description': 'Upon induction:\n\npatients in CHR will receive Blinatumomab at a dose of 15 µg/m²/day as continuous intravenous infusion (CIVI) at a constant flow rate for four weeks, followed by a two-week infusion-free interval, defined as one treatment cycle. At least 2 cycles should be administered, up to a maximum of 5 cycles, if deemed necessary.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ascoli Piceno', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Piero Galieni', 'role': 'CONTACT'}, {'name': 'Piero Galieni', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'U.O.C. Ematologia e Terapia Cellulare - Ospedale "C. e G. Mazzoni" di Ascoli Piceno', 'geoPoint': {'lat': 42.85351, 'lon': 13.57395}}, {'city': 'Avellino', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Nicola Cantore', 'role': 'CONTACT'}, {'name': 'Nicola Cantore', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Az.Ospedaliera S.G.Moscati', 'geoPoint': {'lat': 40.91494, 'lon': 14.79103}}, {'city': 'Bari', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giorgina Specchia', 'role': 'CONTACT'}, {'name': 'Giorgina Specchia', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UO Ematologia con trapianto-Università degli Studi di Bari Aldo Moro', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'city': 'Bergamo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessandro Rambaldi', 'role': 'CONTACT'}, {'name': 'Alessandro Rambaldi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliera - Papa Giovanni XXIII', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'city': 'Bologna', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giovanni Martinelli', 'role': 'CONTACT'}, {'name': 'Giovanni Martinelli', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'city': 'Brindisi', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Angela Melpignano', 'role': 'CONTACT'}, {'name': 'Angela Melpignano', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Divisione di Ematologia Ospedale A. Perrino', 'geoPoint': {'lat': 40.63215, 'lon': 17.93607}}, {'city': 'Catania', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francesco Di Raimondo', 'role': 'CONTACT'}, {'name': 'Francesco Di Raimondo', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'city': 'Florence', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alberto Bosi', 'role': 'CONTACT'}], 'facility': 'Unità di Ricerca e di Malattie del sangue - Ematologia San Luca Vecchio Pad. 16 - 1° Piano', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'city': 'Genova', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Angelo Michele Carella', 'role': 'CONTACT'}, {'name': 'Angelo Michele Carella', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Unità Operative Complesse di Ematologia 1 e 2 Centro Trapianti di Midollo dell'IRCCS AOU San Martino-IST", 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'city': 'Lecce', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Nicola Di Renzo', 'role': 'CONTACT'}, {'name': 'Nicola Di Renzo', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE', 'geoPoint': {'lat': 40.35481, 'lon': 18.17244}}, {'city': 'Mestre', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Renato Bassan', 'role': 'CONTACT'}, {'name': 'Renato Bassan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "U.O. di Ematologia- Ospedale dell'Angelo - Mestre", 'geoPoint': {'lat': 45.49167, 'lon': 12.24538}}, {'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Agostino Cortelezzi', 'role': 'CONTACT'}, {'name': 'Agostino Cortelezzi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia- Padiglione Marcora 2° piano", 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Milan', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Valentina Mancini', 'role': 'CONTACT'}, {'name': 'Valentina Mancini', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale Niguarda " Ca Granda" - SC Ematologia Blocco SUD, Ponti Est, Scala E, 4° piano', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Felicetto Ferrara', 'role': 'CONTACT'}, {'name': 'Delicetto Ferrara', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Fabrizio Pane', 'role': 'CONTACT'}, {'name': 'Fabrizio Pane', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Novara', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Gianluca Gaidano', 'role': 'CONTACT'}, {'name': 'Gianluca Gaidano', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro', 'geoPoint': {'lat': 45.44694, 'lon': 8.62118}}, {'city': 'Orbassano', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giovanna Rege', 'role': 'CONTACT'}, {'name': 'Giovanna Rege', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga-Medicina Interna 2', 'geoPoint': {'lat': 45.00547, 'lon': 7.53813}}, {'city': 'Pagani', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Castello Califano', 'role': 'CONTACT'}, {'name': 'Castello Califano', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'U.O. di Oncoematologia -plesso ospedaliero "A. Tortora" di Pagani', 'geoPoint': {'lat': 40.74199, 'lon': 14.61448}}, {'city': 'Palermo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francesco Fabbiano', 'role': 'CONTACT'}, {'name': 'Francesco Fabbiano', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedali Riuniti "Villa Sofia-Cervello"', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'city': 'Perugia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Brunangelo Falini', 'role': 'CONTACT'}, {'name': 'Brunangelo Falini', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sezione di Ematologia ed Immunologia Clinica - Ospedale S.Maria della Misericordia', 'geoPoint': {'lat': 43.1122, 'lon': 12.38878}}, {'city': 'Pescara', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Paolo Di Bartolomeo', 'role': 'CONTACT'}, {'name': 'Paolo Di Bartolomeo', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ematologia Clinica - Azienda USL di Pescara', 'geoPoint': {'lat': 42.4584, 'lon': 14.20283}}, {'city': 'Reggio Calabria', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francesca Ronco', 'role': 'CONTACT'}, {'name': 'Francesca Ronco', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"', 'geoPoint': {'lat': 38.11047, 'lon': 15.66129}}, {'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Anna Chierichini', 'role': 'CONTACT'}, {'name': 'Anna Chierichini', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Complesso Ospedaliero S. Giovanni Addolorata', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Simona C Sica', 'role': 'CONTACT'}, {'name': 'Simona Sica', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Università Cattolica del Sacro Cuore - Policlinico A. Gemelli', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Roma', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Adriano Venditti', 'role': 'CONTACT'}, {'name': 'Adriano Venditti', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Università degli Studi - Policlinico di Tor Vergata', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Roma', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Stefano C Mancini', 'role': 'CONTACT'}, {'name': 'Stefano Mancini', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UOC Medicina Trasfusionale e Cellule Staminali Azienda Ospedaliera San Camillo Forlanini', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Rome', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Roberto Foà', 'role': 'CONTACT'}, {'name': 'Roberto Foà', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sabina Chiaretti', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Policlinico Umberto I, Hematology Department', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Roberto Foà', 'role': 'CONTACT'}, {'name': 'Roberto Foà', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sabina Chiaretti', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Rozzano', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Matteo Della Porta', 'role': 'CONTACT'}, {'name': 'Matteo Della Porta', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sezione di Ematologia Cancer Center Humanitas', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'city': 'San Giovanni Rotondo', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Nicola Cascavilla', 'role': 'CONTACT'}, {'name': 'Nicola Cascavilla', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza', 'geoPoint': {'lat': 41.70643, 'lon': 15.7277}}, {'city': 'Torino', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Ernesta Audisio', 'role': 'CONTACT'}, {'name': 'Ernesta Audisio', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dipartimento di Oncologia ed Ematologia S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino San Giovanni Battista', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'city': 'Torino', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessandro Cignetti', 'role': 'CONTACT'}, {'name': 'Alessandro Cignetti', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Struttura Complessa a Dir. Universitaria-Ematologia e Terapie Cellulari- A.S.O. Ordine Mauriziano, P.O. Umberto I-Ospedale Torino', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'city': 'Torino', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessandro Cignetti', 'role': 'CONTACT'}, {'name': 'Alessandro Cignetti', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Struttura Complessa a Dir. Universitaria-Ematologia e Terapie Cellulari- A.S.O. Ordine Mauriziano, P.O. Umberto I-Ospedale', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'city': 'Verona', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Massimiliano Bonifacio', 'role': 'CONTACT'}, {'name': 'Massimiliano Bonifacio', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}], 'centralContacts': [{'name': 'Paola Fazi', 'role': 'CONTACT', 'email': 'p.fazi@gimema.it', 'phone': '+39 06.70390521'}, {'name': 'Enrico Crea', 'role': 'CONTACT', 'email': 'e.crea@gimema.it', 'phone': '+39 0670390514'}], 'overallOfficials': [{'name': 'Roberto Foà', 'role': 'STUDY_CHAIR', 'affiliation': 'Policlinico Umberto I, Hematology Department.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Gruppo Italiano Malattie EMatologiche dell'Adulto", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}