Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-26 @ 8:52 PM
Study NCT ID:
NCT01701232
Status:
COMPLETED
Last Update Posted:
2017-11-06
First Post:
2012-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of BCD-020 in Therapy of Indolent Non-Hodgkin's Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belarus', 'Brazil']}, 'conditionBrowseModule': {'meshes': [{'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D018442', 'term': 'Lymphoma, B-Cell, Marginal Zone'}, {'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'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 174}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-02', 'studyFirstSubmitDate': '2012-10-03', 'studyFirstSubmitQcDate': '2012-10-03', 'lastUpdatePostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall response rate', 'timeFrame': 'day 50 (cycle 4)', 'description': 'Estimation of the overall response rate in each treatment arm at the end of treatment'}, {'measure': 'CD20-positive cells count', 'timeFrame': 'day 50', 'description': 'Comparison of peripheral blood B-cell depletion and repletion after BCD-020 and MabThera intravenous administration'}], 'secondaryOutcomes': [{'measure': 'Cmax', 'timeFrame': 'day 22', 'description': 'Estimation of maximum rituximab serum concentrations after administration of BCD-020 to that obtained after administration of MabThera'}, {'measure': 'AUC(0-168)', 'timeFrame': '168 hours', 'description': 'Estimation of rituximab exposition after administration of BCD-020 to that obtained after administration of MabThera'}, {'measure': 'Complete response rate', 'timeFrame': 'day 50', 'description': 'Assessment of complete response rates of BCD-020 and MabThera given as a monotherapy at the end/completion of the treatment'}, {'measure': 'Frequency of AEs/sAEs grade 3-4 (CTCAE v.4.03)', 'timeFrame': 'day 50', 'description': 'Evaluation of the safety profiles of BCD-020 and MabThera'}, {'measure': 'Levels of binding and neutralizing antibodies to rituximab', 'timeFrame': 'day 50', 'description': 'Immunogenicity assessment of BCD-020 and MabThera'}, {'measure': 'AUC(0-1176), AUC(0-inf)', 'timeFrame': 'day 50', 'description': 'Estimation of rituximab serum concentrations after administration of BCD-020 to that obtained after administration of MabThera'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["lymphoma, non-Hodgkin's"], 'conditions': ["Follicular Non-Hodgkin's Lymphoma", 'Nodal Marginal Zone Lymphoma', 'Splenic Marginal Zone Lymphoma']}, 'descriptionModule': {'briefSummary': "This international multi-center, randomized, controlled, open-label study investigated the pharmacokinetics, pharmacodynamics, efficacy and safety of BCD-020 (INN: rituximab, CJSC Biocad) versus MabThera® (INN: rituximab, F. Hoffmann La Roche, Ltd.) both administered as a monotherapy of patients with indolent non-Hodgkin's lymphoma.\n\nPatients were randomized to receive 375 mg/m² BCD-020 as intravenous infusion once a week for 4 weeks or MabThera® at the same regimen."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Having signed a written informed consent;\n* Patients' age is 18 years or more;\n* Diagnosis of CD20-positive indolent non-Hodgkin lymphoma of following morphological types:Follicular non-Hodgkin lymphoma stage II-IV according to Ann Arbor, grade I-II;Nodal marginal zone lymphoma stage II-IV according to Ann Arbor; Splenic marginal zone lymphoma.\n* Life expectancy of not less than 3 months after the enrollment in the study;\n* Morphological and immunohistochemical examination of the tumor (both lymph node biopsy and bone marrow biopsy) - within 3 months before the enrollment in the study ;\n* Performance status ≤2 on the ECOG scale;\n* Hemoglobin \\> 80 g/l; leukocyte count ≥ 3.0×109/l but less than 25×109/l, absolute neutrophil count ≥1.5×109/l, platelet count ≥100×109/l;\n* Presence of at least one measurable lesion;\n* Patient's ability in the investigator's opinion to comply with the protocol procedures;\n* Willingness of patients with preserved reproductive function to use reliable contraception methods (at least two contraception methods in women, e.g., spermicide and condom).\n\nExclusion Criteria:\n\n* Bulky disease - size of any single lesion more than 10 cm in the greatest diameter;\n* Secondary transformation to high-grade lymphoma;\n* Other types of non-Hodgkin lymphomas apart from follicular non-Hodgkin stage II-IV lymphoma according to Ann Arbor, grade 1,2; nodal marginal zone lymphoma stage II-IV according to Ann Arbor; splenic marginal zone lymphoma.\n* Patients regularly taking corticosteroids during 1 month preceding the enrollment in the study;\n* Occurrence of other (aside from NHL) diseases that can distort the assessment of the main disease symptoms expression; mask, enhance, modify the main disease symptoms or induce clinical and laboratory-instrumental symptoms similar to the non-Hodgkin lymphomas; Severe resistant hypertension; Decompensated forms of heart (NYHA class ХСН III, IV), liver and kidney disorders (creatinine level \\>133 µmol/l, AST, ALT, and bilirubin level 3 times exceeding the norm) except for the cases where the symptom is caused by lymphoma; Decompensated respiratory failure; Tumor infiltration of the lungs; Decompensated diabetes mellitus; Active autoimmune diseases; Ongoing infections requiring antimicrobial therapy.\n* Usage of the drugs:\n\nAt any time prior to the enrollment into the study - interferon-based drugs or monoclonal antibodies for the treatment of NHL; Chemotherapy or radiotherapy was completed less than 21 day prior to the enrollment into the study; Vaccination within 1 week prior to the enrollment into the study;\n\n* Presence of any psychiatric disorders including major depressive conditions and/or suicidal thoughts in anamnesis that in opinion of the investigator may put a patient at an excessive risk or influence the ability of patients to fulfill the study protocol;\n* Myocardial infarction less than 1 month before the enrollment into the study;\n* Severe CNS or PNS dysfunctions;\n* Drug and alcohol addiction;\n* Known HIV, HBV, HCV infection, syphilis;\n* Known primary or secondary immunodeficiency;\n* Primary CNS lymphoma or metastasis in the CNS;\n* Known intolerance or allergy to mouse proteins or any components of the study drugs, and also to the premedication drugs;\n* Pregnancy or lactation;\n* Prior or concomitant malignances except for adequately treated basal cell carcinoma and in situ cervical cancer;\n* Any restraints or impossibility to administer the study drug via an intravenous infusion;\n* Major surgery within 1 week prior to the enrollment into the study;\n* Simultaneous participation in any other clinical study or any preceding participation in other studies within 3 months prior to enrollment in this study."}, 'identificationModule': {'nctId': 'NCT01701232', 'briefTitle': "Safety and Efficacy Study of BCD-020 in Therapy of Indolent Non-Hodgkin's Lymphoma", 'organization': {'class': 'INDUSTRY', 'fullName': 'Biocad'}, 'officialTitle': "A Multicenter Open-label Randomized Study of BCD-020 (Rituximab, CJSC BIOCAD, Russia) Efficacy and Safety in Comparison With MabThera (F. Hoffmann-La Roche Ltd., Switzerland) in Monotherapy of CD20-positive Indolent Non-Hodgkin's Lymphoma", 'orgStudyIdInfo': {'id': 'BIORIX (BCD-020-3)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'MabThera', 'description': 'Reference rituximab at a dose of 375 mg/m2 intravenously once a week for four weeks (on days 1, 8, 15 and 22)', 'interventionNames': ['Biological: rituximab']}, {'type': 'EXPERIMENTAL', 'label': 'BCD-020', 'description': 'Proposed rituximab biosimilar at a dose of 375 mg/m2 intravenously once a week for four weeks (on days 1, 8, 15 and 22)', 'interventionNames': ['Biological: rituximab']}], 'interventions': [{'name': 'rituximab', 'type': 'BIOLOGICAL', 'otherNames': ['Biological: BCD-020, MabThera'], 'description': 'Patients will receive rituximab at a dose of 375 mg/m2 intravenously once a week for 4 weeks (on day 1,8,15,22)', 'armGroupLabels': ['BCD-020', 'MabThera']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bogotá', 'country': 'Colombia', 'facility': 'Instituto Nacional de Cancerología', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'city': 'Cali', 'country': 'Colombia', 'facility': 'Fundación Reina Isabel', 'geoPoint': {'lat': 3.43054, 'lon': -76.5199}}, {'city': 'Medellín', 'country': 'Colombia', 'facility': 'Hospital Pablo Tobon Uribe', 'geoPoint': {'lat': 6.245, 'lon': -75.57151}}, {'zip': '380006', 'city': 'Ahmedabad', 'country': 'India', 'facility': 'HCG Multi Specialty Hospitals', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '380009', 'city': 'Ahmedabad', 'country': 'India', 'facility': 'Department of Medical Oncology, Navneet Memorial Hospital, "Sushrusha"', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'city': 'Amaravati', 'country': 'India', 'facility': 'Sujan Surgicals', 'geoPoint': {'lat': 16.514, 'lon': 80.516}}, {'zip': '560027', 'city': 'Bangalore', 'country': 'India', 'facility': 'HCG Bangalore Institute of Oncology', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '560034', 'city': 'Bangalore', 'country': 'India', 'facility': "Department of Medicine (Haemotology), St.John's Medical College Hospital", 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '560099', 'city': 'Bangalore', 'country': 'India', 'facility': 'Narayana Hrudayalaya Hospitals', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'city': 'Bangalore', 'country': 'India', 'facility': 'Srinivasam Cancer Care Hospital', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'city': 'Bhubaneswar', 'country': 'India', 'facility': 'All India Institute of medical Sciences (AIIMS)', 'geoPoint': {'lat': 20.27241, 'lon': 85.83385}}, {'city': 'Bikaner', 'country': 'India', 'facility': 'Acharya Tulasi Regional Cancer Treatment and Research Centre', 'geoPoint': {'lat': 28.01762, 'lon': 73.31495}}, {'zip': '641037', 'city': 'Coimbatore', 'country': 'India', 'facility': 'G.Kuppuswamy Naidu Memorial Hospital', 'geoPoint': {'lat': 11.00555, 'lon': 76.96612}}, {'zip': '580025', 'city': 'Hubli', 'country': 'India', 'facility': 'Medical Oncology Department, The Karnatak Cancer Therapy and Research Institute', 'geoPoint': {'lat': 18.6429, 'lon': 76.21599}}, {'zip': '500024', 'city': 'Hyderabad', 'country': 'India', 'facility': 'BIBI General hospital & cancer center', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'zip': '500034', 'city': 'Hyderabad', 'country': 'India', 'facility': 'Department of Medical Oncology, Basavatarakam Indo-American Cancer Hospital and Research Institute', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'zip': '500034', 'city': 'Hyderabad', 'country': 'India', 'facility': 'Omega Hospitals', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'city': 'Kolkata', 'country': 'India', 'facility': 'Nilratan Siracar Medical College & Hospital', 'geoPoint': {'lat': 22.56263, 'lon': 88.36304}}, {'city': 'Lucknow', 'country': 'India', 'facility': 'King George Medical University', 'geoPoint': {'lat': 26.83928, 'lon': 80.92313}}, {'zip': '625107', 'city': 'Madurai', 'country': 'India', 'facility': 'Department of Radiation Oncology, Meenakshi Mission Hospital & Research Centre', 'geoPoint': {'lat': 9.919, 'lon': 78.11953}}, {'city': 'Nashik', 'country': 'India', 'facility': 'Manas Super Speciality Hospital', 'geoPoint': {'lat': 19.99727, 'lon': 73.79096}}, {'city': 'Vijayawada', 'country': 'India', 'facility': 'City Cancer Center', 'geoPoint': {'lat': 16.50745, 'lon': 80.6466}}, {'zip': '163045', 'city': 'Arkhangelsk', 'country': 'Russia', 'facility': 'Arkhangelsk District Clinical Oncology Dispensary', 'geoPoint': {'lat': 64.5461, 'lon': 40.55183}}, {'zip': '656010', 'city': 'Barnaul', 'country': 'Russia', 'facility': 'City Hospital N8', 'geoPoint': {'lat': 53.36199, 'lon': 83.72786}}, {'zip': '664035', 'city': 'Irkutsk', 'country': 'Russia', 'facility': 'Public health facility "Irkutsk Regional Oncology Center"', 'geoPoint': {'lat': 52.29566, 'lon': 104.29076}}, {'zip': '153013', 'city': 'Ivanovo', 'country': 'Russia', 'facility': 'Ivanovo Regional Oncology Center', 'geoPoint': {'lat': 56.99988, 'lon': 40.97257}}, {'zip': '426009', 'city': 'Izhevsk', 'country': 'Russia', 'facility': 'State Health Care Institution "Republican Clinical Cancer Center," the Ministry of Health of the Udmurt Republic', 'geoPoint': {'lat': 56.85225, 'lon': 53.19862}}, {'zip': '650066', 'city': 'Kemerovo', 'country': 'Russia', 'facility': 'Public health facility "Kemerovo Regional Hospital"', 'geoPoint': {'lat': 55.35417, 'lon': 86.10435}}, {'zip': '350040', 'city': 'Krasnodar', 'country': 'Russia', 'facility': 'Clinical Oncology Dispensary N1', 'geoPoint': {'lat': 45.04534, 'lon': 38.98178}}, {'zip': '305035', 'city': 'Kursk', 'country': 'Russia', 'facility': 'Public health facility "Kursk Regional Cancer Center," Health Committee of Kursk region', 'geoPoint': {'lat': 51.72689, 'lon': 36.18457}}, {'zip': '398005', 'city': 'Lipetsk', 'country': 'Russia', 'facility': 'Public health facility "Lipetsk Regional Oncology Center"', 'geoPoint': {'lat': 52.5876, 'lon': 39.55151}}, {'zip': '105229', 'city': 'Moscow', 'country': 'Russia', 'facility': 'N.N. Burdenko General Military Clinical Hospital', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '123995', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Russian Medical Academy of Post-Graduate Education, Ministry of Health and Social Development of the Russian Federation', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '125167', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Research Center for Hematology MHSD RF', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '125284', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Official body of the health of the city of Moscow "Moscow City Clinical Hospital named after S. P. Botkin"', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '249036', 'city': 'Obninsk', 'country': 'Russia', 'facility': 'Medical Radiological Research Center, Ministry of Health and Social Development of the Russian Federation', 'geoPoint': {'lat': 55.10993, 'lon': 36.61238}}, {'zip': '302028', 'city': 'Oryol', 'country': 'Russia', 'facility': 'Regional government health care "Oryol Regional Hospital"', 'geoPoint': {'lat': 52.96879, 'lon': 36.0791}}, {'zip': '614066', 'city': 'Perm', 'country': 'Russia', 'facility': 'Perm Region Oncology Dispensary', 'geoPoint': {'lat': 58.01046, 'lon': 56.25017}}, {'zip': '185000', 'city': 'Petrozavodsk', 'country': 'Russia', 'facility': 'V.A. Baranov Republican Hospital of Ministry of Health republic Karelia', 'geoPoint': {'lat': 61.78491, 'lon': 34.34691}}, {'zip': '357502', 'city': 'Pyatigorsk', 'country': 'Russia', 'facility': 'Pyatigorsk Oncology Center', 'geoPoint': {'lat': 44.05, 'lon': 43.05036}}, {'zip': '191024', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Russian Research Institute of Hematology and Transfusiology Federal State Institution of Federal Medical and Biological Agency', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '193312', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'St. Petersburg State Health Care Institution "Alexander City Hospital"', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '197022', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Saint Petersburg City Clinical Oncology Center', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '197022', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Saint Petersburg Pavlov State Medical University', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '197341', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'V.A. Almazov Federal Center for Heart, Blood and Endocrinology, Ministry of Health and Social Development of the Russian Federation', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '197758', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'N.N.Petrov Oncology Research Center', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Russian scientific center of radiology and surgery technologies', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '194044', 'city': 'Saint Petersurg', 'country': 'Russia', 'facility': 'The federal government military educational institution of higher education, "Military Medical Academy named after SM Kirov\'s\' Ministry of Defense"'}, {'zip': '214000', 'city': 'Smolensk', 'country': 'Russia', 'facility': 'Provincial health official body "Smolensk Regional Clinical Oncological Dispensary"', 'geoPoint': {'lat': 54.77826, 'lon': 32.05088}}, {'zip': '354057', 'city': 'Sochi', 'country': 'Russia', 'facility': 'Oncology Dispensary 2', 'geoPoint': {'lat': 43.59699, 'lon': 39.72477}}, {'zip': '390013', 'city': 'Tambov', 'country': 'Russia', 'facility': 'Tambov Regional Oncology Center', 'geoPoint': {'lat': 52.73632, 'lon': 41.44102}}, {'zip': '445846', 'city': 'Tolyatti', 'country': 'Russia', 'facility': 'Municipal Health "Clinical Hospital № 5" Togliatti', 'geoPoint': {'lat': 53.5303, 'lon': 49.3461}}, {'zip': '300053', 'city': 'Tula', 'country': 'Russia', 'facility': 'Tula Regional Hospital', 'geoPoint': {'lat': 54.19609, 'lon': 37.61822}}, {'zip': '625041', 'city': 'Tyumen', 'country': 'Russia', 'facility': 'Public health care setting of the Tyumen region "Regional Oncology Center"', 'geoPoint': {'lat': 57.15222, 'lon': 65.52722}}, {'zip': '450005', 'city': 'Ufa', 'country': 'Russia', 'facility': 'State Health Care Institution Republican Clinical Hospital named after G. G. Kuvatova', 'geoPoint': {'lat': 54.74306, 'lon': 55.96779}}, {'zip': '450054', 'city': 'Ufa', 'country': 'Russia', 'facility': 'Republican Clinical Oncology Dispensary of Ministry of Health republic Bashkortostan', 'geoPoint': {'lat': 54.74306, 'lon': 55.96779}}, {'zip': '400138', 'city': 'Volgograd', 'country': 'Russia', 'facility': 'Volgograd District Oncology Dispensary №1', 'geoPoint': {'lat': 48.71378, 'lon': 44.4976}}, {'zip': '620137', 'city': 'Yekaterinburg', 'country': 'Russia', 'facility': 'Municipal Institution "Central City Hospital № 7"', 'geoPoint': {'lat': 56.85733, 'lon': 60.61529}}, {'city': 'Vereeniging', 'country': 'South Africa', 'facility': 'Medi-Clinic Vereeniging', 'geoPoint': {'lat': -26.67313, 'lon': 27.92615}}, {'zip': '29000', 'city': 'Khmelnytskyi', 'country': 'Ukraine', 'facility': "Khmel'nyts'kyy Regional Hospital, Hematology Department", 'geoPoint': {'lat': 49.41835, 'lon': 26.97936}}, {'zip': '03022', 'city': 'Kiev', 'country': 'Ukraine', 'facility': 'National Cancer Institute of Ukraine, Oncohematology Department', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '79044', 'city': 'Lviv', 'country': 'Ukraine', 'facility': 'State Institution "Institute of Blood Pathology and Transfusion Medicine AMS of Ukraine", Hematology Department', 'geoPoint': {'lat': 49.83826, 'lon': 24.02324}}], 'overallOfficials': [{'name': 'Roman Ivanov, PhD,MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CJSC Biocad'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biocad', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}