Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2026-01-05 @ 6:02 PM
Study NCT ID:
NCT00462332
Status:
COMPLETED
Last Update Posted:
2013-09-06
First Post:
2007-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Fludarabine and Alemtuzumab or Cyclophosphamide Followed by Peripheral Blood Stem Cell Transplant or Alemtuzumab in Treating Patients With Advanced or Progressive Chronic Lymphocytic Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}], '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': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C024352', 'term': 'fludarabine'}, {'id': 'D000074323', 'term': 'Alemtuzumab'}, {'id': 'D014180', 'term': 'Transplantation'}], 'ancestors': [{'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'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'a.piciocchi@gimema.it', 'phone': '+39 06 70390513', 'title': 'Alfonso Piciocchi', 'organization': 'GIMEMA Foundation Data Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'High Risk Patientes', 'description': 'Category of risk will be defined according to biological features.', 'otherNumAtRisk': 45, 'otherNumAffected': 32, 'seriousNumAtRisk': 45, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Low Risk Patients', 'description': 'Category of risk will be defined according to biological features.', 'otherNumAtRisk': 41, 'otherNumAffected': 33, 'seriousNumAtRisk': 41, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'AEs related to Campath infusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 77, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 33, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 20, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Hematologic Toxicity (Grade >=3)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 39, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 71, 'numAffected': 25}], 'organSystem': 'Blood and lymphatic system disorders'}], 'seriousEvents': [{'term': 'Grade >=3 hematologic toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 41, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients With Complete Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Risk Patients'}, {'id': 'OG001', 'title': 'High Risk Patients'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 2 years from study entry', 'description': '* Normal clinical or X-ray examination (lymph nodes, liver, spleen)\n* No symptoms\n* Lymphocytes higher or equal to 4.0 per 10\\^9/L\n* Neutrophils lower or equal to 1.5 per 10\\^9/L\n* Platelets \\>100 per 10\\^9/L\n* Hb \\>11.0 g/dL\n* Bone marrow lymphs according to age, lymphocytes \\<30%, no nodules.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Toxicity', 'timeFrame': 'At 2 years from study entry', 'description': 'Number of AEs and SAEs', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Risk Patientes', 'description': 'Category of risk will be defined according to biological features.'}, {'id': 'OG001', 'title': 'Low Risk Patients', 'description': 'Category of risk will be defined according to biological features.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.57', 'spread': '10', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 2 years and a half from study entry', 'unitOfMeasure': 'years', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Event-free Survival', 'timeFrame': 'At 2 years from study entry', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Disease-free Survival', 'timeFrame': 'At 2 years from study entry', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'High Risk Patientes', 'description': 'Category of risk will be defined according to biological features.'}, {'id': 'FG001', 'title': 'Low Risk Patients', 'description': 'Category of risk will be defined according to biological features.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'High Risk Patientes', 'description': 'Category of risk will be defined according to biological features.'}, {'id': 'BG001', 'title': 'Low Risk Patients', 'description': 'Category of risk will be defined according to biological features.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.02', 'spread': '6.09', 'groupId': 'BG000'}, {'value': '52.73', 'spread': '6.24', 'groupId': 'BG001'}, {'value': '53.02', 'spread': '6.13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Italy', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-20', 'studyFirstSubmitDate': '2007-04-18', 'resultsFirstSubmitDate': '2012-08-20', 'studyFirstSubmitQcDate': '2007-04-18', 'lastUpdatePostDateStruct': {'date': '2013-09-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-07-25', 'studyFirstPostDateStruct': {'date': '2007-04-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients With Complete Response', 'timeFrame': 'At 2 years from study entry', 'description': '* Normal clinical or X-ray examination (lymph nodes, liver, spleen)\n* No symptoms\n* Lymphocytes higher or equal to 4.0 per 10\\^9/L\n* Neutrophils lower or equal to 1.5 per 10\\^9/L\n* Platelets \\>100 per 10\\^9/L\n* Hb \\>11.0 g/dL\n* Bone marrow lymphs according to age, lymphocytes \\<30%, no nodules.'}], 'secondaryOutcomes': [{'measure': 'Toxicity', 'timeFrame': 'At 2 years from study entry', 'description': 'Number of AEs and SAEs'}, {'measure': 'Length of Survival', 'timeFrame': 'At 2 years and a half from study entry'}, {'measure': 'Event-free Survival', 'timeFrame': 'At 2 years from study entry'}, {'measure': 'Disease-free Survival', 'timeFrame': 'At 2 years from study entry'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stage III chronic lymphocytic leukemia', 'stage IV chronic lymphocytic leukemia'], 'conditions': ['Leukemia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.gimema.it', 'label': 'GIMEMA Foundation Website'}]}, 'descriptionModule': {'briefSummary': "RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. A peripheral stem cell transplant using stem cells from the patient or a donor may replace the patient's immune cells that were destroyed by chemotherapy.\n\nPURPOSE: This phase II trial is studying how well giving fludarabine together with alemtuzumab or cyclophosphamide followed by peripheral blood stem cell transplant or alemtuzumab works in treating patients with advanced or progressive chronic lymphocytic leukemia.", 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the antitumor activity of induction therapy comprising fludarabine phosphate with either alemtuzumab or cyclophosphamide followed by peripheral blood stem cell transplantation or alemtuzumab in patients with advanced or progressive chronic lymphocytic leukemia.\n\nSecondary\n\n* Determine the toxicity of this regimen in these patients.\n* Determine the length of survival, event-free survival, and disease-free survival of patients treated with this regimen.\n* Evaluate the relationship between different clinical and biological disease characteristics, therapeutic response, and survival.\n\nOUTLINE: This is a pilot, multicenter study. Patients are stratified according to biological risk profile (high vs low risk).\n\n* Group 1 (high-risk patients):\n\n * Induction therapy: Patients receive fludarabine phosphate IV and alemtuzumab IV on days 1-3. Treatment repeats for 4 courses.\n\nPatients with no response (no good clinical partial response, steady disease, or progressive disease) after induction therapy are removed from the study. Other patients proceed to post-induction therapy based on response to induction therapy.\n\n* Post-induction therapy:\n\n * Complete clinical, cytometric, and molecular response: Patients undergo peripheral blood stem cell (PBSC) mobilization with cytarabine IV twice daily on days 1-3 and filgrastim (G-CSF) followed by no further therapy.\n * Response to induction therapy and evidence of residual disease (complete clinical and cytometric response with molecular evidence of disease; complete clinical response only; or good clinical partial response): Patients without an HLA familial matched donor undergo PBSC mobilization with cytarabine IV twice daily on days 1-3 and G-CSF. Patients with sufficient harvested autologous PBSCs undergo autologous PBSC transplantation (with BEAM conditioning regimen \\[carmustine, etoposide, cytarabine, and melphalan\\]). Patients without sufficient harvested\n * PBSCs receive alemtuzumab subcutaneously (SC) weekly for 6 weeks. Patients who do not achieve molecular remission after 6 weeks of alemtuzumab receive 6 additional weeks of treatment. Patients with an HLA familial matched\n * undergo reduced-intensity allogeneic stem cell transplantation (with cyclophosphamide, thiotepa, and fludarabine phosphate as conditioning regimen).\n\n * Group 2 (low-risk patients):\n* Induction therapy: Patients receive fludarabine phosphate and cyclophosphamide on days 1-3. Treatment repeats every month for 4 courses. Patients achieving at least a partial response receive 2 additional courses.\n\nPatients achieving complete clinical response with cytometric and molecular response; complete clinical response with a cytometric response; or complete clinical response after completion of induction therapy (i.e., partial response or greater) receive no further treatment. Patients with no response or disease progression proceed to post-induction therapy.\n\n* Post-induction therapy: Patients receive alemtuzumab SC weekly for 6 weeks. Patients who do not achieve complete remission after 6 weeks of alemtuzumab receive 6 additional weeks of treatment.\n\nPROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Diagnosis of chronic lymphocytic leukemia (CLL)\n\n * Advanced or progressive disease with ≥ 2 active clinical signs\n\nPATIENT CHARACTERISTICS:\n\n* Fertile patients must use adequate contraception\n* No positive Coomb's test with signs of hemolysis\n* No active infection\n* No uncontrolled severe disease\n* No known hypersensitivity or anaphylactic reactions to murine antibodies or proteins\n* No other malignancies within the past 2 years except for adequately treated malignancies\n* No significant traumatic injury within the past 4 weeks\n* No coexisting medical or psychological condition that would limit study compliance\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* No prior treatment for CLL\n* No major surgery within the past 4 weeks\n* No prior chemotherapy"}, 'identificationModule': {'nctId': 'NCT00462332', 'acronym': 'LLC0405', 'briefTitle': 'Fludarabine and Alemtuzumab or Cyclophosphamide Followed by Peripheral Blood Stem Cell Transplant or Alemtuzumab in Treating Patients With Advanced or Progressive Chronic Lymphocytic Leukemia', 'organization': {'class': 'OTHER', 'fullName': "Gruppo Italiano Malattie EMatologiche dell'Adulto"}, 'officialTitle': 'Phase II Pilot Trial to Evaluate the Efficacy of a Combined Therapy Approach for Young CLL Patients With Advanced and Progressive Disease Stratified According to the Biological Prognostic Features', 'orgStudyIdInfo': {'id': 'LLC0405'}, 'secondaryIdInfos': [{'id': 'LLC0405', 'type': 'OTHER', 'domain': 'GIMEMA'}, {'id': '2005-002476-15', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High risk patientes', 'description': 'Category of risk will be defined according to biological features.', 'interventionNames': ['Drug: Fludarabine', 'Drug: Campath', 'Procedure: Transplant']}, {'type': 'EXPERIMENTAL', 'label': 'Low risk patients', 'description': 'Category of risk will be defined according to biological features.', 'interventionNames': ['Drug: Fludarabine', 'Drug: Campath']}], 'interventions': [{'name': 'Fludarabine', 'type': 'DRUG', 'description': 'Induction therapy', 'armGroupLabels': ['High risk patientes']}, {'name': 'Campath', 'type': 'DRUG', 'description': 'Induction therapy', 'armGroupLabels': ['High risk patientes']}, {'name': 'Transplant', 'type': 'PROCEDURE', 'description': 'Post-induction therapy', 'armGroupLabels': ['High risk patientes']}, {'name': 'Campath', 'type': 'DRUG', 'description': 'Post-induction therapy', 'armGroupLabels': ['High risk patientes']}, {'name': 'Fludarabine', 'type': 'DRUG', 'description': 'Induction therapy', 'armGroupLabels': ['Low risk patients']}, {'name': 'Campath', 'type': 'DRUG', 'description': 'Induction therapy', 'armGroupLabels': ['Low risk patients']}, {'name': 'Campath', 'type': 'DRUG', 'description': 'Post-induction therapy', 'armGroupLabels': ['Low risk patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alessandria', 'country': 'Italy', 'facility': 'S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo', 'geoPoint': {'lat': 44.90924, 'lon': 8.61007}}, {'zip': '70124', 'city': 'Bari', 'country': 'Italy', 'facility': 'Universita Degli Studi di Bari', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'zip': '86100', 'city': 'Campobasso', 'country': 'Italy', 'facility': 'Universita Cattolica del Sacro Cuore - Campobasso', 'geoPoint': {'lat': 41.55947, 'lon': 14.66737}}, {'zip': '95124', 'city': 'Catania', 'country': 'Italy', 'facility': 'Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'zip': '88100', 'city': 'Catanzaro', 'country': 'Italy', 'facility': 'Ospedale Regionale A. Pugliese', 'geoPoint': {'lat': 38.88247, 'lon': 16.60086}}, {'zip': '87100', 'city': 'Cosenza', 'country': 'Italy', 'facility': 'Ospedale Civile Cosenza', 'geoPoint': {'lat': 39.2989, 'lon': 16.25307}}, {'zip': '44100', 'city': 'Ferrara', 'country': 'Italy', 'facility': 'Universita di Ferrara', 'geoPoint': {'lat': 44.83804, 'lon': 11.62057}}, {'zip': '50011', 'city': 'Florence', 'country': 'Italy', 'facility': 'Azienda Ospedaliera di Firenze', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '16132', 'city': 'Genova', 'country': 'Italy', 'facility': 'Ospedale San Martino', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'city': 'Lecce', 'country': 'Italy', 'facility': 'ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE', 'geoPoint': {'lat': 40.35481, 'lon': 18.17244}}, {'city': 'Messina', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Papardo', 'geoPoint': {'lat': 38.19394, 'lon': 15.55256}}, {'city': 'Messina', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Universitaria - Policlinico G. Martino Dipartimento di Medicina Interna - U.O. Messina', 'geoPoint': {'lat': 38.19394, 'lon': 15.55256}}, {'zip': '20122', 'city': 'Milan', 'country': 'Italy', 'facility': 'Ospedale Maggiore Policlinico', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '41100', 'city': 'Modena', 'country': 'Italy', 'facility': 'Azienda Ospedaliera - Universitaria di Modena', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'city': 'Pescara', 'country': 'Italy', 'facility': 'U.O. Ematologia Clinica - Azienda USL di Pescara', 'geoPoint': {'lat': 42.4584, 'lon': 14.20283}}, {'zip': '89100', 'city': 'Reggio Calabria', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Bianchi Melacrino Morelli', 'geoPoint': {'lat': 38.11047, 'lon': 15.66129}}, {'zip': '00133', 'city': 'Rome', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Universitaria Policlinico Tor Vergata', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '00144', 'city': 'Rome', 'country': 'Italy', 'facility': "Ospedale Sant' Eugenio", 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '00161', 'city': 'Rome', 'country': 'Italy', 'facility': 'Università Degli Studi "La Sapienza"', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '00168', 'city': 'Rome', 'country': 'Italy', 'facility': 'Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Siena', 'country': 'Italy', 'facility': 'U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte"', 'geoPoint': {'lat': 43.31822, 'lon': 11.33064}}, {'zip': '10126', 'city': 'Turin', 'country': 'Italy', 'facility': 'Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}, {'zip': '33100', 'city': 'Udine', 'country': 'Italy', 'facility': 'Policlinico Universitario Udine', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}], 'overallOfficials': [{'name': 'Roberto Foa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universita Degli Studi "La Sapeinza"'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Gruppo Italiano Malattie EMatologiche dell'Adulto", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}