Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-02-22 @ 9:37 AM
Study NCT ID:
NCT00091234
Status:
UNKNOWN
Last Update Posted:
2012-07-24
First Post:
2004-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D015471', 'term': 'Leukemia, Basophilic, Acute'}, {'id': 'D015472', 'term': 'Leukemia, Eosinophilic, Acute'}, {'id': 'D004915', 'term': 'Leukemia, Erythroblastic, Acute'}, {'id': 'D007947', 'term': 'Leukemia, Megakaryoblastic, Acute'}, {'id': 'D007948', 'term': 'Leukemia, Monocytic, Acute'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D015479', 'term': 'Leukemia, Myelomonocytic, Acute'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000079982', 'term': 'Gemtuzumab'}], 'ancestors': [{'id': 'D000080084', 'term': 'Calicheamicins'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 279}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'lastUpdateSubmitDate': '2012-07-23', 'studyFirstSubmitDate': '2004-09-07', 'studyFirstSubmitQcDate': '2004-09-08', 'lastUpdatePostDateStruct': {'date': '2012-07-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients able to start continuation therapy (Phase II)'}, {'measure': 'Overall survival (Phase III)'}], 'secondaryOutcomes': [{'measure': 'Rate of complete remission (CR+CRp)by the end of continuation therapy, for patients in the GO arms (Phase II)'}, {'measure': 'Overall survival (Phase II)'}, {'measure': 'Toxicity (CTCAE grading), including time to hematological recovery (Phase II & III)'}, {'measure': 'Rate of complete remisison (CR+CRp) by the end of induction and by the end of continuation therapy, for patients in GO arm (Phase III)'}, {'measure': 'Disease-free survival for patients who reached CR or CRp (Phase III)'}, {'measure': 'Progression-free survival from randomization for patients in GO arm (Phase III)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['adult acute myeloid leukemia with 11q23 (MLL) abnormalities', 'adult acute myeloid leukemia with inv(16)(p13;q22)', 'adult acute myeloid leukemia with t(16;16)(p13;q22)', 'adult acute myeloid leukemia with t(8;21)(q22;q22)', 'untreated adult acute myeloid leukemia', 'secondary acute myeloid leukemia', 'adult acute basophilic leukemia', 'adult acute eosinophilic leukemia', 'adult erythroleukemia (M6a)', 'adult pure erythroid leukemia (M6b)', 'adult acute megakaryoblastic leukemia (M7)', 'adult acute minimally differentiated myeloid leukemia (M0)', 'adult acute monoblastic leukemia (M5a)', 'adult acute monocytic leukemia (M5b)', 'adult acute myeloblastic leukemia with maturation (M2)', 'adult acute myeloblastic leukemia without maturation (M1)', 'adult acute myelomonocytic leukemia (M4)'], 'conditions': ['Leukemia']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Amadori S, Suciu S, Selleslag D, et al.: Phase II-III study of gemtuzumab ozogamicin monotherapy versus best supportive care in older patients with newly diagnosed AML unfit for intensive chemotherapy: first results of the EORTC-GIMEMA AML-19 trial. [Abstract] Blood 112 (11): A-762, 2008.'}, {'pmid': '26811524', 'type': 'DERIVED', 'citation': 'Amadori S, Suciu S, Selleslag D, Aversa F, Gaidano G, Musso M, Annino L, Venditti A, Voso MT, Mazzone C, Magro D, De Fabritiis P, Muus P, Alimena G, Mancini M, Hagemeijer A, Paoloni F, Vignetti M, Fazi P, Meert L, Ramadan SM, Willemze R, de Witte T, Baron F. Gemtuzumab Ozogamicin Versus Best Supportive Care in Older Patients With Newly Diagnosed Acute Myeloid Leukemia Unsuitable for Intensive Chemotherapy: Results of the Randomized Phase III EORTC-GIMEMA AML-19 Trial. J Clin Oncol. 2016 Mar 20;34(9):972-9. doi: 10.1200/JCO.2015.64.0060. Epub 2016 Jan 25.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether gemtuzumab ozogamicin is more effective than standard supportive care in treating older patients who have acute myeloid leukemia.\n\nPURPOSE: This randomized phase II/III trial is studying two different gemtuzumab ozogamicin regimens to see how well they work compared to standard supportive care in treating older patients with previously untreated acute myeloid leukemia.', 'detailedDescription': 'OBJECTIVES:\n\n* Compare the feasibility, toxicity, and antileukemic activity of two different dosing regimens of gemtuzumab ozogamicin (GO) vs standard supportive care in older patients with previously untreated acute myeloid leukemia who are not candidates for intensive chemotherapy. (phase II)\n* Compare the efficacy and toxicity of the best dosing regimen of GO selected from phase II vs standard supportive care, in terms of overall survival, in these patients. (phase III)\n\nOUTLINE: This is a randomized, open-label, multicenter phase II study followed by a phase III study. Patients are stratified according to age (61 to 75 vs 76 to 80 vs 81 and over), CD33-positivity of bone marrow blasts (\\< 20% vs 20-80% vs \\> 80% vs unknown), initial WBC before hydroxyurea administration (\\< 30,000/mm\\^3 vs ≥ 30,000/mm\\^3), WHO performance status (0-1 vs 2 vs 3-4), and participating center.\n\n* Phase II: Patients are randomized to 1 of 3 treatment arms.\n\n * Arm I: Patients receive gemtuzumab ozogamicin (GO) IV over 2 hours on days 1 and 8. Patients with stable or responding disease at day 36 receive GO IV over 2 hours every 4 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.\n * Arm II: Patients receive GO IV over 2 hours on days 1, 3, and 5. Patients with stable or responding disease at day 36 receive GO IV over 2 hours every 4 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.\n * Arm III: Patients receive standard supportive care.\n* Phase III: Patients are randomized to 1 of 2 treatment arms.\n\n * Arm I: Patients receive the selected treatment (arm I or arm II) from phase II.\n * Arm II: Patients receive standard supportive care. Patients who receive GO treatment are followed monthly for 1 year and then every 3 months thereafter. Patients who receive standard supportive care are followed at least every 4 weeks.\n\nPROJECTED ACCRUAL: A total of 259 patients (75 for phase II \\[25 per treatment arm\\] and 184 for phase III \\[92 per treatment arm\\]) will be accrued for this study within 2.5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '61 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed acute myeloid leukemia (AML)\n\n * At least 20% bone marrow blasts by bone marrow aspiration or biopsy\n * All subtypes except M3 (acute promyelocytic leukemia) are allowed\n* Previously untreated primary or secondary disease (including AML after myelodysplastic syndromes)\n* Ineligible for intensive chemotherapy, as defined by 1 of the following criteria:\n\n * 61 to 75 years old AND WHO performance status \\> 2 AND/OR unwilling to receive intensive chemotherapy\n * Over 75 years old\n* No blast crisis of chronic myeloid leukemia\n* No AML supervention after other myeloproliferative disease\n* WBC \\< 30,000/mm\\^3 and meets 1 of the following criteria:\n\n * WBC \\< 30,000/mm\\^3 at diagnosis AND had no prior treatment with hydroxyurea\n * WBC ≥ 30,000/mm\\^3 at diagnosis AND received mandatory pretreatment with hydroxyurea (up to 14 days duration) until WBC \\< 30,000/mm\\^3\n* No active CNS leukemia\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* See Disease Characteristics\n* 61 and over\n\nPerformance status\n\n* See Disease Characteristics\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* See Disease Characteristics\n\nHepatic\n\n* Bilirubin ≤ 1.5 times upper limit of normal (ULN)\n\nRenal\n\n* Creatinine ≤ 1.5 times ULN\n\nCardiovascular\n\n* No arrhythmia requiring chronic treatment\n* No congestive heart failure\n* No symptomatic ischemic heart disease\n* No other severe cardiovascular disease\n\nPulmonary\n\n* No severe pulmonary dysfunction ≥ grade 3\n\nOther\n\n* No alcohol abuse\n* No severe neurological or psychiatric disease\n* No active uncontrolled infection or severe systemic infection\n* No other malignancy\n* No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up\n* HIV negative\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)\n* No concurrent antiangiogenic drugs\n\nChemotherapy\n\n* See Disease Characteristics\n* Concurrent low-dose cytostatic agents (i.e., thioguanine or mercaptopurine) allowed for palliative care (standard supportive care arm only)\n\nEndocrine therapy\n\n* Prior corticosteroids (duration ≤ 14 days ) for primary or secondary AML allowed\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* Not specified\n\nOther\n\n* No other concurrent cytotoxic drugs\n* No other concurrent experimental therapy\n* No concurrent tyrosine kinase inhibitors'}, 'identificationModule': {'nctId': 'NCT00091234', 'acronym': 'AML-19', 'briefTitle': 'Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia', 'organization': {'class': 'NETWORK', 'fullName': 'European Organisation for Research and Treatment of Cancer - EORTC'}, 'officialTitle': 'Gemtuzumab Ozogamicin (GO) Monotherapy Versus Standard Supportive Care for Previously Untreated AML in Elderly Patients Who Are Not Eligible for Intensive Chemotherapy: A Randomized Phase II/III Trial (AML-19) of the EORTC-LG and GIMEMA-ALWP', 'orgStudyIdInfo': {'id': 'EORTC-06031'}, 'secondaryIdInfos': [{'id': 'EORTC-06031'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'gemtuzumab ozogamicin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2020', 'city': 'Antwerp', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '32-3-280-3111'}], 'facility': 'Ziekenhuis Netwerk Antwerpen Middelheim', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '8000', 'city': 'Bruges', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '32-50-45-2111'}], 'facility': 'AZ Sint-Jan', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'zip': '1000', 'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '32-2-541-3510'}], 'facility': 'Institut Jules Bordet', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1070', 'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '32-2-555-3806'}], 'facility': 'Hopital Universitaire Erasme', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': 'B-2650', 'city': 'Edegem', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '32-03-821-3375'}], 'facility': 'Universitair Ziekenhuis Antwerpen', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': 'B-4000', 'city': 'Liège', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '32-4-366-7111'}], 'facility': 'CHU Liege - Domaine Universitaire du Sart Tilman', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': 'B-4800', 'city': 'Verviers', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '328-721-2111'}], 'facility': 'Centre Hospitalier Peltzer-La Tourelle', 'geoPoint': {'lat': 50.58907, 'lon': 5.86241}}, {'city': 'Arezzo Cap', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'Ospedale S Donato, USL-8'}, {'zip': '70124', 'city': 'Bari', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '39-080-547-8660'}], 'facility': 'Universita Degli Studi di Bari', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'city': 'Brescia', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'Universita Di Brescia', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'zip': '090100', 'city': 'Cagliari', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '39-070-609-3149'}], 'facility': 'Ospedale Binaghi', 'geoPoint': {'lat': 39.23054, 'lon': 9.11917}}, {'zip': '09121', 'city': 'Cagliari', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '39-070-609-5204'}], 'facility': 'Ospedale Oncologico A. 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Pugliese', 'geoPoint': {'lat': 38.88247, 'lon': 16.60086}}, {'zip': '44100', 'city': 'Ferrara', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '39-532-209-100'}], 'facility': 'Universita di Ferrara', 'geoPoint': {'lat': 44.83804, 'lon': 11.62057}}, {'zip': '73100', 'city': 'Lecce', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '39-083-266-1235'}], 'facility': 'Azienda Ospedaliera Vito Fazzi', 'geoPoint': {'lat': 40.35481, 'lon': 18.17244}}, {'zip': '41100', 'city': 'Modena', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '39-059-422-4373'}], 'facility': 'Azienda Ospedaliera - Universitaria di Modena', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'zip': 'I-01027', 'city': 'Montefiascone', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '39-07-618-331'}], 'facility': 'Ospedale Di Montefiascone', 'geoPoint': {'lat': 42.54255, 'lon': 12.03192}}, {'zip': '80127', 'city': 'Naples', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '39-081-747-3011'}], 'facility': 'Azienda Ospedaliera di Rilievo Nazionale A.Cardarelli', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}, {'city': 'Novara', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'Ospedale Maggiore della Carita', 'geoPoint': {'lat': 45.44694, 'lon': 8.62118}}, {'zip': '90127', 'city': 'Palermo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '39-091-655-2321'}], 'facility': 'Azienda Ospedaliera Policlinico Paolo Giaccone', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'city': 'Palermo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '39-91-680-6111'}], 'facility': 'Ospedale La Maddalena - Palermo', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'zip': '43100', 'city': 'Parma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '39-0521-702-441'}], 'facility': 'Azienda Ospedaliera Di Parma', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}, {'zip': '06122', 'city': 'Perugia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Massimo F. Martelli, MD', 'role': 'CONTACT', 'email': 'ematol@unipg.it', 'phone': '39-75-5783219'}], 'facility': 'Policlinico Monteluce', 'geoPoint': {'lat': 43.1122, 'lon': 12.38878}}, {'zip': 'I-61100', 'city': 'Pesaro', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'G. Lucarelli', 'role': 'CONTACT', 'phone': '0039-0721-36424'}], 'facility': 'Ospedale San Salvatore', 'geoPoint': {'lat': 43.90921, 'lon': 12.9164}}, {'zip': '65100', 'city': 'Pescara', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT'}], 'facility': 'Ospedale Civile Pescara', 'geoPoint': {'lat': 42.4584, 'lon': 14.20283}}, {'city': 'Potenza', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'Ospedale San Carlo', 'geoPoint': {'lat': 40.64175, 'lon': 15.80794}}, {'zip': '48100', 'city': 'Ravenna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '39-544-285-247'}], 'facility': 'Ospedale Sta. 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Gemelli - Universita Cattolica del Sacro Cuore', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '00184', 'city': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT'}], 'facility': 'H. San Giovanni-Addolorata Hospital', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuliana Alimena', 'role': 'CONTACT', 'phone': '39-06-857-951'}], 'facility': 'Universita Degli Studi "La Sapeinza"', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '07100', 'city': 'Sassari', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '39-79-228-280'}], 'facility': 'Istituto di Ematologia Universita - University di Sassari', 'geoPoint': {'lat': 40.72586, 'lon': 8.55552}}, {'zip': '53100', 'city': 'Siena', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '39-0577-586-429'}], 'facility': 'Universita di Siena', 'geoPoint': {'lat': 43.31822, 'lon': 11.33064}}, {'zip': '34100', 'city': 'Trieste', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '39-040-399-2232'}], 'facility': "Ospedale Maggiore dell' Universita", 'geoPoint': {'lat': 45.64953, 'lon': 13.77678}}, {'zip': '5211 NL', 'city': "'s-Hertogenbosch", 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '31-73-699-2000'}], 'facility': 'Jeroen Bosch Ziekenhuis', 'geoPoint': {'lat': 51.69917, 'lon': 5.30417}}, {'zip': '1091 HA', 'city': 'Amsterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '31-20-599-9111'}], 'facility': 'Onze Lieve Vrouwe Gasthuis', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '2300 RC', 'city': 'Leiden', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '31-71-526-9111'}], 'facility': 'Leiden University Medical Center', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': 'NL-6500 HB', 'city': 'Nijmegen', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT'}], 'facility': 'Universitair Medisch Centrum St. Radboud - Nijmegen', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'centralContacts': [{'name': 'Hilde Breyssens', 'role': 'CONTACT', 'email': 'hilde.breyssens@eortc.be'}], 'overallOfficials': [{'name': 'Sergio Amadori, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'EORTC - AZIENDA OSPEDALLERA UNIVERSITARIA - POLICLINICO TOR VERGATA, IT'}, {'name': 'Giuliana Alimena', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'GIMEMA - Universita Degli Studi "La Sapeinza"'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Organisation for Research and Treatment of Cancer - EORTC', 'class': 'NETWORK'}, 'collaborators': [{'name': "Gruppo Italiano Malattie EMatologiche dell'Adulto", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}