Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'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'}]}, '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 414}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-07', 'studyFirstSubmitDate': '2019-11-11', 'studyFirstSubmitQcDate': '2019-11-15', 'lastUpdatePostDateStruct': {'date': '2024-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Activity of GO in combination with chemotherapy in terms of MRD negativity achievement', 'timeFrame': '2 months', 'description': 'Percentage of MRD negativity after consolidation in patients treated in induction and consolidation with GO'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['De-novo', 'Favorable risk', 'Intermediate risk', 'Gemtuzumab ozogamicin', 'Acute Myeloid Leukemia'], 'conditions': ['Acute Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': 'MRD driven study. Addition of gemtuzumab to conventional chemotherapy to reduce MRD of patients with favorable/intermediate-risk AML. Post-consolidation assessment of MRD.', 'detailedDescription': 'Setting up a multicenter, MRD (Minimal Residual Disease)-driven study that relies on addition of gemtuzumab ozogamicin to conventional chemotherapy to reduce the pre-transplant levels of MRD of patients with favorable/intermediate-risk (according to ELN 2017) AML. Post-consolidation assessment of MRD will be exploited to establish the final risk assignment and to verify whether the delivery of a post remission therapy intensity (AuSCT, Autologous Stem Cell Transplant, vs ASCT, Allogeneic Stem Cell Transplant) of which is MRD-driven will improve the outcome in terms of anti-leukemic efficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed written informed consent according to ICH/EU/GCP and national/local laws\n2. Patients aged between 18 and 60 years\n3. Patients previously untreated for their AML by other chemotherapeutic agents (except for no more than 7 days HU) or radiotherapy\n4. Unequivocal diagnosis of de novo AML according to WHO diagnostic criteria (at least 20% blasts in the bone marrow), other than acute promyelocytic leukemia, documented by bone marrow aspiration (or biopsy in case of dry tap) (not supervening after other myeloproliferative disease or myelodysplastic syndromes of ≥ 6 months duration)\n5. Patients with favorable-intermediate AML according to ELN 2017 (except for FLT3-ITD/TKD positive AML)\n6. WHO performance status 0-3\n7. Adequate renal (serum creatinine ≤ 2 x the institutional ULN) and liver (total serum bilirubin ≤ 2 x ULN; serum ALT and AST ≤ 2.5 x ULN) function, unless considered due to organ leukemic involvement\n8. Left Ventricular Ejection Fraction (LVEF) ≥ 50%, as determined by echocardiogram\n9. Absence of severe concomitant neurological or psychiatric diseases and congestive heart failure or active uncontrolled infection\n10. Absence of any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and the follow-up schedule.\n\nExclusion Criteria:\n\n1. Patients already treated for their AML by other chemotherapeutic agents (except for no more than 7 days HU) or radiotherapy\n2. Acute promyelocytic leukemia\n3. Blast crisis of chronic myeloid leukemia\n4. FLT3-ITD/TKD positive AML\n5. AML supervening after other myeloproliferative disease\n6. AML supervening after antecedent myelodysplastic syndromes ≥ 6 months duration\n7. Therapy-related AML\n8. Other active or progressive malignant diseases.\n9. Inadequate renal or liver function (metabolic abnormalities \\> 2-2.5 times the normal upper limit)\n10. Severe heart failure requiring diuretics\n11. Ejection fraction \\< 50%\n12. Uncontrolled infections\n13. Severe concomitant neurological or psychiatric diseases\n14. Patients who are pregnant or adults of reproductive potential not employing an effective method of birth control. Women of childbearing potential must have a negative serum pregnancy test within 48 hours prior to administration of chemotherapy. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients must agree to employ an effective barrier method of birth control throughout the study and for at least 6 months following discontinuation of study drug.'}, 'identificationModule': {'nctId': 'NCT04168502', 'briefTitle': 'Gemtuzumab Chemotherapy MRD Levels; Adult Untreated, de Novo, Fav Interm Risk AML', 'organization': {'class': 'OTHER', 'fullName': "Gruppo Italiano Malattie EMatologiche dell'Adulto"}, 'officialTitle': 'Phase 3 Study to Assess Gemtuzumab, in Combination With Standard Chemotherapy, on MRD Levels, in Adult, 18-60 Years, With Previously Untreated de Novo Fav-interm Risk AML', 'orgStudyIdInfo': {'id': 'AML1819'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental arm', 'description': 'Induction:\n\nGemtuzumab 3 mg/m2 day 1,4,7 Daunorubicin 60 mg/m2 day 1-3 Cytosine arabinoside 200 mg/m2 day 1-7\n\nConsolidation:\n\nGemtuzumab 3 mg/m2 day 1 Daunorubicin 50 mg/m2 day 4-6 Cytosine arabinoside 500 mg/m2 twice a day, day 1-6\n\nAllogeneic transplantation or Autologous transplantation according to MRD level\n\nclinical observation', 'interventionNames': ['Drug: Gemtuzumab Ozogamicin']}], 'interventions': [{'name': 'Gemtuzumab Ozogamicin', 'type': 'DRUG', 'description': 'Patients will receive induction and consolidation with Gemtuzumab ozogamicin, Daunorubicin and Cytarabine', 'armGroupLabels': ['Experimental arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alessandria', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Zallio', 'role': 'CONTACT'}], 'facility': 'A.O. - SS. Antonio e Biagio e Cesare Arrigo - SC Ematologia', 'geoPoint': {'lat': 44.90924, 'lon': 8.61007}}, {'city': 'Ancona', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Attilio Olivieri', 'role': 'CONTACT', 'email': 'a.olivieri@univpm.it'}], 'facility': 'Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona - Sod Clinica Ematologica', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'city': 'Ascoli Piceno', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Piero Galieni', 'role': 'CONTACT', 'email': 'piero.galieni@sanita.marche.it', 'phone': '3388149974'}], 'facility': 'Area Vasta N. 5 Ascoli Piceno - S. Benedetto Del Tronto, Presidio Ospedaliero Av5 Osp. Gen. Prov.Le "C.G.Mazzoni" - Uoc Ematologia', 'geoPoint': {'lat': 42.85351, 'lon': 13.57395}}, {'city': 'Avellino', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Storti', 'role': 'CONTACT'}], 'facility': 'AO "San Giuseppe Moscati" - UOC Ematologia con unità di trapianto', 'geoPoint': {'lat': 40.91494, 'lon': 14.79103}}, {'city': 'Bari', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Carluccio', 'role': 'CONTACT'}], 'facility': 'AOU Consorziale Policlinico "Aldo Moro" - UO Ematologia con trapianto', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'city': 'Bologna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Curti', 'role': 'CONTACT'}], 'facility': 'Policlinico S. Orsola - Malpighi - UOC Ematologia', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'city': 'Caserta', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Andrea Camera', 'role': 'CONTACT', 'email': 'ancamera@unina.it', 'phone': '330344420'}], 'facility': "Ao Sant'Anna E San Sebastiano - Caserta - Uoc Onco Ematologia", 'geoPoint': {'lat': 41.07262, 'lon': 14.33231}}, {'city': 'Castelfranco Veneto', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Michele Gottardi', 'role': 'CONTACT', 'email': 'michele.gottardi@aulss2.veneto.it', 'phone': '3476260749'}], 'facility': 'U.O.C. Oncoematologia - Istituto Oncologico Veneto Irccs, Presidio Ospedaliero S. 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Giovanni Battista Molinette - Torino - Sc Ematologia 2', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'city': 'Treviso', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Endri Mauro', 'role': 'CONTACT', 'email': 'endri.mauro@aas5.sanita.fvg.it'}], 'facility': 'Unità Operativa Di Ematologia - Presidio Ospedaliero Di Treviso - Azienda Ulss N.2 Marca Trevigiana', 'geoPoint': {'lat': 45.66673, 'lon': 12.2416}}, {'city': 'Trieste', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francesco Zaja', 'role': 'CONTACT', 'email': 'francesco.zaja@asuits.sanita.fvg.it'}], 'facility': 'Azienda Sanitaria Universitaria Integrata Di Trieste - Sc Ematologia', 'geoPoint': {'lat': 45.64953, 'lon': 13.77678}}, {'city': 'Udine', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Anna Candoni', 'role': 'CONTACT', 'email': 'candoni.anna@aoud.sanita.fvg.it'}], 'facility': 'Asui Di Udine - Presidio Ospedaliero "Santa Maria Della Misericordia" - Clinica Ematologica', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}], 'centralContacts': [{'name': 'Paola Fazi', 'role': 'CONTACT', 'email': 'p.fazi@gimema.it', 'phone': '0670390528'}, {'name': 'Enrico Crea', 'role': 'CONTACT', 'email': 'e.crea@gimema.it', 'phone': '0670390514'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Gruppo Italiano Malattie EMatologiche dell'Adulto", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}