Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-02-24 @ 8:26 AM
Study NCT ID:
NCT05327894
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-31
First Post:
2022-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interfant-21 Treatment Protocol for Infants Under 1 Year With KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D015456', 'term': 'Leukemia, Biphenotypic, Acute'}], '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': 'C510808', 'term': 'blinatumomab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Definition: Provide details about the Interventional Study Model. Limit: 1000 characters.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2030-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-28', 'studyFirstSubmitDate': '2022-04-07', 'studyFirstSubmitQcDate': '2022-04-07', 'lastUpdatePostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event free survival (EFS).', 'timeFrame': '5 years', 'description': 'The primary endpoint is EFS, defined as the time from diagnosis to resistance to induction, relapse, death from any cause or second malignancy (whichever occurs first), or time to last follow-up (censored) for patients without events.'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '8 years', 'description': 'The endpoints for analysis by risk group will be EFS, cumulative incidence (or percentage) of resistance to induction, cumulative incidence of relapse (CIR), death in complete remission (CR) and second malignancy.'}, {'measure': 'Endpoints by risk group', 'timeFrame': '8 years', 'description': 'The endpoints for analysis by risk group will be EFS, cumulative incidence (or percentage) of resistance to induction, cumulative incidence of relapse (CIR), death in complete remission (CR) and second malignancy.'}, {'measure': 'Outcome for the entire study cohort and according to risk group', 'timeFrame': '8 years', 'description': 'Outcome for the entire study cohort and according to risk group will be evaluated in terms of the protocol specific definition of EFS follows: the time from diagnosis to, resistance to proto-col, relapse, death from any cause or second malignancy (whichever occurs first), or time to last follow-up for patients without events. Cumulative incidence (or percentage) of resistance, CIR, death in CR and second malignancy will also be estimated.'}, {'measure': 'Minimal Residual Disease', 'timeFrame': '8 years', 'description': 'MRD response as defined in the protocol and frequencies of MRD levels'}, {'measure': 'CD19 (cluster of differentiation antigen 19) negative relapse', 'timeFrame': '8 years', 'description': 'Proportion of CD19 negative relapses in the entire study cohort and according to risk group'}, {'measure': 'Myeloid lineage switches', 'timeFrame': '8 years', 'description': 'Proportion of myeloid lineage switches in the entire study cohort and according to risk group'}, {'measure': 'Grade ≥3 adverse event', 'timeFrame': '8 years', 'description': 'Proportion of grade ≥3 adverse event (AEs) during the blinatumomab course(s). Proportion of adverse events of special interest (AESIs) and serious adverse events (SAEs) in all protocol phases.'}, {'measure': 'Grade ≥2 cardiac disorders', 'timeFrame': '5 years', 'description': 'Proportion of grade ≥2 cardiac disorders at 2 and 5 years after diagnosis'}, {'measure': 'Overall survival after 1st relapse', 'timeFrame': '8 years', 'description': 'Overall survival (OS) after first relapse, defined as the time from first relapse to death from any cause, in the entire study cohort and according to risk group'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['infant under one year', 'KMT2A-wildtype'], 'conditions': ['Acute Lymphoblastic Leukemia', 'Mixed Phenotype Acute Leukemia']}, 'descriptionModule': {'briefSummary': 'This study is a treatment protocol with blinatumomab for infants under 1 year old who are diagnosed with acute lymphoblastic leukemia with a specific unfavorable genetic alteration. The purpose of the study is to improve the outcome of this disease in infants.', 'detailedDescription': 'All infants that are eligible for this study and for whom the parents/legal representatives give informed consent will be enrolled in this study. All patients will receive one cycle of blinatumomab on top of the standard treatment backbone after induction therapy. Medium risk patients, that respond well to the 1st cycle will be treated with a 2nd cycle of blinatumomab replacing one chemo course after consolidation therapy. If they do not respond well enough they will be treated according to the current treatment standard. Minimal residual disease will be used to determine the response to blinatumomab. High risk patients will be eligible for allogeneic stem cell transplantation after the first blinatumomab cycle if they are Minimal Residual Disease (MRD) negative (defined as \\< 0.01%). Also medium risk patients with insufficient MRD response after induction or after the 1st cycle of blinatumomab will be allocated to high risk treatment and will be eligible for allogeneic stem cell transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Year', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with newly diagnosed B- precursor ALL or B-cell MPAL (single lineage) according to the WHO classification of tumours of haematopoietic and lymphoid tissues (revised 4th edition 2017), with KMT2A-rearrangement.\n2. ≤ 365 days of age at the time of diagnosis of ALL.\n3. Written informed consent of the parent(s) or other legally authorized guardian of the patient according to local law and regulations.\n\nExclusion criteria for blinatumomab:\n\n1. KMT2A-wildtype patients.\n2. Multilineage MPAL\n3. T-ALL.\n4. Age \\> 365 days at the time of diagnosis.\n5. Down syndrome.\n6. Relapsed ALL.\n7. Treatment with systemic corticosteroids (equivalent prednisone \\>10 mg/m2/day) for more than one week and/or any chemotherapeutic agent in the 4-week interval prior to diagnosis. Patients who received corticosteroids by aerosol are eligible for the study.\n\nIf exclusion criteria for blinatumomab are met, the patient should be treated according to the protocol but without blinatumomab.'}, 'identificationModule': {'nctId': 'NCT05327894', 'acronym': 'Interfant-21', 'briefTitle': 'Interfant-21 Treatment Protocol for Infants Under 1 Year With KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'Princess Maxima Center for Pediatric Oncology'}, 'officialTitle': 'Interfant-21 International Collaborative Treatment Protocol for Infants Under One Year With KMT2A-rearranged Acute Lymphoblastic Leukemia or Mixed Phenotype Acute Leukemia.', 'orgStudyIdInfo': {'id': '2021-000213-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Medium Risk (MR)', 'description': 'Subject is defined as MR if \\> 6months of age at diagnosis, OR \\< 6 months of age with White Blood cell Count (WBC) \\< 300 at diagnosis and good prednisone response. Subject gets 1st cycle of blinatumomab. If MRD is \\>0.01%, after 1st cycle of blinatumomab, subject will be allocated to HR treatment from that phase, and will be eligible for HSCT. If MRD is undetectable or \\< 0.01% after the 1st cycle of blinatumomab (TP2) patient will be eligible for replacement of MARMA by 2nd cycle of blinatumomab after receipt of lymphoid style consolidation (Protocol IB) or of myeloid style consolidation (ADE/MAE).', 'interventionNames': ['Drug: Blinatumomab']}, {'type': 'OTHER', 'label': 'High risk (HR)', 'description': 'Subject is defined as HR if \\< 6 months of age with WBC \\> 300 at diagnosis OR poor prednisone response. Also MR patients with end of induction MRD ≥ 1%, or MRD \\> 0.01% after the 1st cycle of blinatumomab, will be allocated to HR treatment. Subject gets 1 cycle of blinatumomab.\n\nThereafter patient is eligible for hematopoietic stem cell transplantation (HSCT) with or without experimental therapy in an investigational window.', 'interventionNames': ['Drug: Blinatumomab']}], 'interventions': [{'name': 'Blinatumomab', 'type': 'DRUG', 'otherNames': ['Cycle 1'], 'description': '1st cycle: 15 μg/m2/day as a 4 week continuous IV infusion for patients with a M1 marrow. For patients with a M2/M3 marrow a step-dosing strategy is required with a dose of 5 μg/m2/day in week 1 followed by 15 μg/m2/day in weeks 2, 3, and 4.', 'armGroupLabels': ['High risk (HR)', 'Medium Risk (MR)']}, {'name': 'Blinatumomab', 'type': 'DRUG', 'otherNames': ['Cycle 2'], 'description': '2nd cycle: 15 μg/m2/day as a 4 week continuous iv infusion', 'armGroupLabels': ['Medium Risk (MR)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital de Pediatría S.A.M.I.C. "Juan P. Garrahan"', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Clayton', 'state': 'Victoria', 'country': 'Australia', 'facility': "Australian and New Zealand Children's Haematology/Oncology Group", 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}, {'city': 'Adelaide', 'country': 'Australia', 'facility': 'North Adelaide- Womens and Childrens Hospital', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'city': 'Clayton', 'country': 'Australia', 'facility': "Monash Children's Hosptial", 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}, {'city': 'New Lambton Heights', 'country': 'Australia', 'facility': "New Lambton Heights- John Hunter Children's Hospital", 'geoPoint': {'lat': -32.92466, 'lon': 151.69364}}, {'city': 'Parkville', 'country': 'Australia', 'facility': "Royal Children's Hospital (Children's Cancer Centre)", 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'city': 'Perth', 'country': 'Australia', 'facility': "Perth Children's Hospital", 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'city': 'South Brisbane', 'country': 'Australia', 'facility': "Queensland Children's Hospital", 'geoPoint': {'lat': -27.48034, 'lon': 153.02049}}, {'city': 'Sydney', 'country': 'Australia', 'facility': 'Sydney Childrens Hospital', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'city': 'Westmead', 'country': 'Australia', 'facility': 'The Childrens Hospital at Westmead', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'city': 'Vienna', 'country': 'Austria', 'facility': "St. Anna Children's Hospital", 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Antwerp', 'country': 'Belgium', 'facility': 'Antwerp University Hospital', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'city': 'Brussels', 'country': 'Belgium', 'facility': 'Cliniques Universitaires Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Brussels', 'country': 'Belgium', 'facility': 'Hôpital Universitaire des Enfants Reine Fabiola', 'geoPoint': {'lat': 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'facility': 'Institute of Hematology and Pediatric Oncology', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Robert Debré, APHP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Rouen', 'country': 'France', 'facility': 'CHU Charles Nicolle', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Augsburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Augsburg', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Charite Universitaetsmedizin Berlin KöR', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Dortmund', 'country': 'Germany', 'facility': 'Klinikum Dortmund gGmbH', 'geoPoint': {'lat': 51.51494, 'lon': 7.466}}, {'city': 'Giessen', 'country': 'Germany', 'facility': 'Justus-Liebig-Universitaet Giessen', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}, {'city': 'Halle', 'country': 'Germany', 'facility': 'Universitaetsklinikum Halle (Saale) AöR', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'University Medical Center Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universtitätsklinikum Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Universitätsklinikum Heidelberg AöR', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'city': 'Kiel', 'country': 'Germany', 'facility': 'Universitaetsklinikum Schleswig-Holstein AöR', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'city': 'Krefeld', 'country': 'Germany', 'facility': 'HELIOS Klinikum Krefeld GmbH', 'geoPoint': {'lat': 51.33645, 'lon': 6.55381}}, {'city': 'Münster', 'country': 'Germany', 'facility': 'Universitaetsklinikum Muenster AöR', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'city': 'Stuttgart', 'country': 'Germany', 'facility': 'Klinikum Der Landeshauptstadt Stuttgart gKAöR', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'city': 'Tübingen', 'country': 'Germany', 'facility': 'Universitaetsklinikum Tuebingen AöR', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'city': 'Athens', 'country': 'Greece', 'facility': "Aghia Sophia' Children's Hospital", 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'HeSPHO', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Heraklion', 'country': 'Greece', 'facility': 'University General Hospital Of Heraklion', 'geoPoint': {'lat': 35.32787, 'lon': 25.14341}}, {'city': 'Marousi', 'country': 'Greece', 'facility': 'Mitera', 'geoPoint': {'lat': 38.05, 'lon': 23.8}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'University Semmelweis', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Pécs', 'country': 'Hungary', 'facility': 'University of Pécs', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}, {'city': 'Dublin', 'country': 'Ireland', 'facility': "National Children's Cancer Service", 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Napoli', 'country': 'Italy', 'facility': "L'Azienda Ospedaliera Di Rilievo Nazionale Santobono-Pausilipon", 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'IRCCS Ospedale Pediatrico Bambino Gesù', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Chiba', 'country': 'Japan', 'facility': 'Chiba University Hospital', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'city': 'Ehime', 'country': 'Japan', 'facility': 'Ehime University Hospital'}, {'city': 'Hiroshima', 'country': 'Japan', 'facility': 'Hiroshima University Hospital', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'city': 'Hokkaido', 'country': 'Japan', 'facility': 'Hokkaido University Hospital'}, {'city': 'Hyōgo', 'country': 'Japan', 'facility': 'Hyogo Prefectural Kobe Childrens Hospital', 'geoPoint': {'lat': 43.36667, 'lon': 144.43333}}, {'city': 'Kagoshima', 'country': 'Japan', 'facility': 'Kagoshima University Hospital', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'city': 'Kanagawa', 'country': 'Japan', 'facility': 'Kanagawa Childrens Medical Center', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'city': 'Kyoto', 'country': 'Japan', 'facility': 'Kyoto Prefectural University of Medicine', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'city': 'Kyoto', 'country': 'Japan', 'facility': 'Kyoto University Hospital', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'city': 'Mie', 'country': 'Japan', 'facility': 'Mie University Hospital', 'geoPoint': {'lat': 32.96667, 'lon': 131.58333}}, {'city': 'Nagoya', 'country': 'Japan', 'facility': 'Nagoya University Graduate School of Medicine', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'Osaka City General Hospital', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'Osaka University Graduate School of Medicine 2-2', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Saitama', 'country': 'Japan', 'facility': 'Saitama Prefectural Childrens Medical Center', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'city': 'Shizuoka', 'country': 'Japan', 'facility': 'Shizuoka Childrens Hospital', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'National Center for Child Health and Development', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'The University of Tokyo Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Tokyo Metropolitan Childre's Medical Center', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tōhoku', 'country': 'Japan', 'facility': 'Tohoku University Hospital', 'geoPoint': {'lat': 35.81882, 'lon': 139.57138}}, {'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'Vilnius University Hospital Santaros Klinikos', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'zip': '3584 CS', 'city': 'Utrecht', 'state': 'Utrecht', 'country': 'Netherlands', 'facility': 'Princess Máxima Center for pediatric oncology', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'city': 'Bergen', 'country': 'Norway', 'facility': 'Haukeland University Hospital', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}, {'city': 'Trondheim', 'country': 'Norway', 'facility': 'St. Olavs Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}, {'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Instituto Portugues de Oncologica Lisboa', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'city': 'Jeddah', 'country': 'Saudi Arabia', 'facility': 'Jeddah-King Abdulaziz Medical City', 'geoPoint': {'lat': 21.49012, 'lon': 39.18624}}, {'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'King Abdulaziz Medical City, King Abdullah International Medical Research Center', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}, {'city': 'Bratislava', 'country': 'Slovakia', 'facility': "National Institute of Children's Diseases", 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': "Vall D'hebron Institut De Recerca", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Infantil Universitario Nino Jesus', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Seville', 'country': 'Spain', 'facility': 'University Hospital Virgen Del Rocio S.L.', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Universitario Y Politecnico La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Childrens Cancer Center Queen Silvia Children´s Hospital, Sahlgrenska University Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Linköping', 'country': 'Sweden', 'facility': 'Linkoping University Hospital', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}, {'city': 'Lund', 'country': 'Sweden', 'facility': 'Skane University Hospital', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Umeå', 'country': 'Sweden', 'facility': 'Umea University Hospital', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}], 'overallOfficials': [{'name': 'Janine Stutterheim, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Princess Maxima Center for Pediatric Oncology in The Netherlands'}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'timeFrame': 'The Clinical Study Report (CSR) will be made available within 6 months upon study end.', 'ipdSharing': 'YES', 'description': 'all individual participant data that underlie results in a publication', 'accessCriteria': 'A summary of the study results will be made public via www.clinical trials.gov as well as to Ethical committees/ Health Authorities and all participating patients by providing them through their treating physicians a patient letter with a summary of the results.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Princess Maxima Center for Pediatric Oncology', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Milano Bicocca', 'class': 'OTHER'}, {'name': 'Amgen Europe B.V', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}