Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 4:40 AM
Study NCT ID:
NCT07431060
Status:
RECRUITING
Last Update Posted:
2026-02-24
First Post:
2026-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modified LCH-III Regimen With or Without Luvometinib for Multisystem Pediatric Langerhans Cell Histiocytosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006646', 'term': 'Histiocytosis, Langerhans-Cell'}], 'ancestors': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D015614', 'term': 'Histiocytosis'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D014750', 'term': 'Vincristine'}, {'id': 'D015122', 'term': 'Mercaptopurine'}], 'ancestors': [{'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D013438', 'term': 'Sulfhydryl Compounds'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011687', 'term': 'Purines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-13', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-20', 'studyFirstSubmitDate': '2026-02-13', 'studyFirstSubmitQcDate': '2026-02-20', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event-Free survival rate', 'timeFrame': 'From Day 1 until the date of first event or last follow-up, assessed up to 2 years.', 'description': 'Event-free survival (EFS) is defined as the time from Day 1 to the first occurrence of any event, including disease reactivation , second primary malignancy, or death from any cause. Events will be assessed by clinical examination, imaging, and laboratory tests. The 2-year EFS rate will be estimated using the Kaplan-Meier method, reported as percentage with 95% confidence interval.'}], 'secondaryOutcomes': [{'measure': 'Objective response rate', 'timeFrame': 'At 1 month and 3 months post-treatment', 'description': 'Objective response rate (ORR) is defined as the proportion of participants achieving NAD or ADB at the specified time points. Responses will be assessed by clinical evaluation, imaging, and risk organ function (if involved). ORR will be reported separately at 1 month and 3 months as percentage of participants with NAD or ADB (combined), with exact 95% confidence intervals.'}, {'measure': 'Overall survival rate', 'timeFrame': 'From Day1 until date of death from any cause or last follow-up, assessed up to 2 years.', 'description': 'Overall survival (OS) is defined as Day 1 to death from any cause. Participants alive at last follow-up will be censored. The 2-year OS rate will be estimated using the Kaplan-Meier method and reported as percentage with 95% confidence interval.'}, {'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v5.0', 'timeFrame': 'From Day 1 until through study completion, an average of 2 years', 'description': 'Safety and tolerability of the combination regimen (luvometinib added to modified LCH-III chemotherapy: prednisone + Vincristine backbone) will be assessed by the number of participants experiencing treatment-related adverse events (TRAEs), and serious adverse events (SAEs). Events will be graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Data will be summarized as: Incidence of any TRAE (percentage of participants) , Incidence by maximum grade (e.g., Grade 3-5) ,Incidence of specific events of interest (e.g., skin rash, hypertriglyceridemia, cytopenias) and Rate of treatment discontinuation due to toxicity'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Langerhans Cell Histiocytosis', 'Luvometinib'], 'conditions': ['Langerhans Cell Histiocytosis (LCH)']}, 'referencesModule': {'references': [{'pmid': '38231288', 'type': 'RESULT', 'citation': 'Lei J, Wang W, Lin D, Zhu C, Jia W, Weng W, Liu X, Ma Y, Wang Z, Yang L, He X, He Y, Li Y. Vemurafenib combined with chemotherapy achieved sustained remission in pediatric LCH: a multi-center observational study. J Cancer Res Clin Oncol. 2024 Jan 17;150(1):12. doi: 10.1007/s00432-023-05551-y.'}, {'pmid': '37216396', 'type': 'RESULT', 'citation': 'Evseev D, Osipova D, Kalinina I, Raykina E, Ignatova A, Lyudovskikh E, Baidildina D, Popov A, Zhogov V, Semchenkova A, Litvin E, Kotskaya N, Cherniak E, Voronin K, Burtsev E, Bronin G, Vlasova I, Purbueva B, Fink O, Pristanskova E, Dzhukaeva I, Erega E, Novichkova G, Maschan A, Maschan M. Vemurafenib combined with cladribine and cytarabine results in durable remission of pediatric BRAF V600E-positive LCH. Blood Adv. 2023 Sep 26;7(18):5246-5257. doi: 10.1182/bloodadvances.2022009067.'}, {'pmid': '38501390', 'type': 'RESULT', 'citation': 'Karri V, Lin H, Velazquez J, Batajoo A, Parekh D, Stanton W, Abhyankar H, El-Mallawany NK, Agrusa J, Eckstein O, Gulati N, Schwartz J, Woods-Swafford W, Boyd J, Saha A, Allen CE, McClain KL. Clinical, radiological and molecular responses to combination chemotherapy with MAPK pathway inhibition in relapsed and refractory Langerhans cell histiocytosis. Br J Haematol. 2024 May;204(5):1882-1887. doi: 10.1111/bjh.19380. Epub 2024 Mar 19.'}, {'pmid': '33958797', 'type': 'RESULT', 'citation': 'Bigenwald C, Le Berichel J, Wilk CM, Chakraborty R, Chen ST, Tabachnikova A, Mancusi R, Abhyankar H, Casanova-Acebes M, Laface I, Akturk G, Jobson J, Karoulia Z, Martin JC, Grout J, Rafiei A, Lin H, Manz MG, Baccarini A, Poulikakos PI, Brown BD, Gnjatic S, Lujambio A, McClain KL, Picarsic J, Allen CE, Merad M. BRAFV600E-induced senescence drives Langerhans cell histiocytosis pathophysiology. Nat Med. 2021 May;27(5):851-861. doi: 10.1038/s41591-021-01304-x. Epub 2021 May 6.'}, {'pmid': '29263218', 'type': 'RESULT', 'citation': 'Hogstad B, Berres ML, Chakraborty R, Tang J, Bigenwald C, Serasinghe M, Lim KPH, Lin H, Man TK, Remark R, Baxter S, Kana V, Jordan S, Karoulia Z, Kwan WH, Leboeuf M, Brandt E, Salmon H, McClain K, Poulikakos P, Chipuk J, Mulder WJM, Allen CE, Merad M. RAF/MEK/extracellular signal-related kinase pathway suppresses dendritic cell migration and traps dendritic cells in Langerhans cell histiocytosis lesions. J Exp Med. 2018 Jan 2;215(1):319-336. doi: 10.1084/jem.20161881. Epub 2017 Dec 20.'}, {'pmid': '41035796', 'type': 'RESULT', 'citation': 'Cao XX, Zhu Q, Cai Z, Ma J, Zhou H, Chang L, Zhong LP, Wu ZL, Wang X, Han P, Lin HM, Wei Z, Guo JY, Zheng Y, Li J. Luvometinib in patients with Langerhans cell histiocytosis, Erdheim-Chester disease, and other histiocytic neoplasms: a single-arm, multicentre, phase 2 study. EClinicalMedicine. 2025 Sep 17;88:103486. doi: 10.1016/j.eclinm.2025.103486. eCollection 2025 Oct.'}, {'pmid': '40751881', 'type': 'RESULT', 'citation': 'Keam SJ. Luvometinib: First Approval. Drugs. 2025 Sep;85(9):1177-1183. doi: 10.1007/s40265-025-02217-6. Epub 2025 Aug 2.'}, {'pmid': '36884302', 'type': 'RESULT', 'citation': 'Whitlock JA, Geoerger B, Dunkel IJ, Roughton M, Choi J, Osterloh L, Russo M, Hargrave D. Dabrafenib, alone or in combination with trametinib, in BRAF V600-mutated pediatric Langerhans cell histiocytosis. Blood Adv. 2023 Aug 8;7(15):3806-3815. doi: 10.1182/bloodadvances.2022008414.'}, {'pmid': '37731389', 'type': 'RESULT', 'citation': 'Cournoyer E, Ferrell J, Sharp S, Ray A, Jordan M, Dandoy C, Grimley M, Roy S, Lorsbach R, Merrow AC, Nelson A, Bartlett A, Picarsic J, Kumar A. Dabrafenib and trametinib in Langerhans cell histiocytosis and other histiocytic disorders. Haematologica. 2024 Apr 1;109(4):1137-1148. doi: 10.3324/haematol.2023.283295.'}, {'pmid': '31513482', 'type': 'RESULT', 'citation': 'Donadieu J, Larabi IA, Tardieu M, Visser J, Hutter C, Sieni E, Kabbara N, Barkaoui M, Miron J, Chalard F, Milne P, Haroche J, Cohen F, Helias-Rodzewicz Z, Simon N, Jehanne M, Kolenova A, Pagnier A, Aladjidi N, Schneider P, Plat G, Lutun A, Sonntagbauer A, Lehrnbecher T, Ferster A, Efremova V, Ahlmann M, Blanc L, Nicholson J, Lambilliote A, Boudiaf H, Lissat A, Svojgr K, Bernard F, Elitzur S, Golan M, Evseev D, Maschan M, Idbaih A, Slater O, Minkov M, Taly V, Collin M, Alvarez JC, Emile JF, Heritier S. Vemurafenib for Refractory Multisystem Langerhans Cell Histiocytosis in Children: An International Observational Study. J Clin Oncol. 2019 Nov 1;37(31):2857-2865. doi: 10.1200/JCO.19.00456. Epub 2019 Sep 12.'}, {'pmid': '15049016', 'type': 'RESULT', 'citation': 'Haupt R, Nanduri V, Calevo MG, Bernstrand C, Braier JL, Broadbent V, Rey G, McClain KL, Janka-Schaub G, Egeler RM. Permanent consequences in Langerhans cell histiocytosis patients: a pilot study from the Histiocyte Society-Late Effects Study Group. Pediatr Blood Cancer. 2004 May;42(5):438-44. doi: 10.1002/pbc.20021.'}, {'pmid': '38501389', 'type': 'RESULT', 'citation': 'Parekh D, Lin H, Batajoo A, Peckham-Gregory E, Karri V, Stanton W, Scull B, Fleishmann R, El-Mallawany N, Eckstein OS, Prudowsky ZD, Gulati N, Agrusa JE, Ahmed AZ, Chu R, Dietz MS, Goldman SC, Hogarty MD, Imran H, Intzes S, Kim JM, Kopp LM, Levy CF, Neff P, Pillai PM, Sisk BA, Schiff DE, Trobaugh-Lotrario AD, Walkovich K, McClain KL, Allen CE. Clofarabine monotherapy in aggressive, relapsed and refractory Langerhans cell histiocytosis. Br J Haematol. 2024 May;204(5):1888-1893. doi: 10.1111/bjh.19376. Epub 2024 Mar 19.'}, {'pmid': '40167581', 'type': 'RESULT', 'citation': 'Lin H, Batajoo A, Peckham-Gregory E, Zinn D, Eckstein OS, El-Mallawany NK, Gulati N, Prudowsky ZD, Scull B, Velazquez J, Abhyankar H, Simko SJ, Vakula D, Fleischmann R, Karri V, Hicks MJ, Fisher KE, Curry CV, Roy A, Schiff D, Heym KM, Scheurer ME, Parsons DW, Merad M, Man TK, McClain KL, Picarsic J, Allen CE. BRAF V600E-positive mononuclear cells in blood at diagnosis portend treatment failure and neurodegeneration in pediatric LCH. Blood. 2025 Jul 10;146(2):206-218. doi: 10.1182/blood.2024026671.'}, {'pmid': '32106306', 'type': 'RESULT', 'citation': 'Rodriguez-Galindo C, Allen CE. Langerhans cell histiocytosis. Blood. 2020 Apr 16;135(16):1319-1331. doi: 10.1182/blood.2019000934.'}]}, 'descriptionModule': {'briefSummary': "Langerhans cell histiocytosis (LCH) is the most common histiocytic disorder in children, caused by excessive proliferation and accumulation of Langerhans cells (a type of immune cell) in various body tissues. The annual incidence is about 2.6-8.9 cases per million children.Clinical presentation varies widely.\n\nMild (low-risk) cases may resolve spontaneously or cause minimal issues with excellent outcomes. Severe multisystem LCH involves multiple organs, particularly high-risk sites such as liver, spleen, or bone marrow, leading to poorer prognosis and potential life-threatening complications without appropriate treatment.Standard first-line therapy for many children is prednisone (a corticosteroid) plus vinblastine (chemotherapy). Trials like LCH-III show near-100% survival in low-risk disease, but long-term survival drops to \\~80% in high-risk cases. Reactivation occurs in \\~37% of low-risk patients post-treatment, and \\~50% of children eventually develop resistance, resulting in progression or relapse. Treatment failure heightens risks of long-term sequelae, including growth retardation, endocrine dysfunction, and neurological damage, severely impacting quality of life.\n\nMore than half of LCH cases harbor the BRAF V600E mutation, activating the MAPK pathway abnormally. This has driven development of targeted MAPK inhibitors (e.g., vemurafenib, dabrafenib, trametinib), which demonstrate strong efficacy and acceptable safety (mainly manageable skin rash) in relapsed/refractory pediatric cases, with no reported secondary malignancies to date. These agents provide rapid symptom relief and durable control, though monotherapy often fails to eradicate abnormal cells in multisystem disease, leading to relapse after discontinuation.\n\nNo MAPK inhibitors were previously approved specifically for LCH. In 2025, luvometinib (developed by Fosun Pharma, China; a selective MEK1/2 inhibitor) received approval in China for adult LCH and histiocytic neoplasms. Adult studies showed \\~83% objective response rate and \\~74% progression-free at ≥12 months, with mostly mild side effects (skin issues, hypertriglyceridemia) and no discontinuations due to serious toxicity.\n\nLaboratory evidence indicates MAPK overactivation confers apoptosis resistance to LCH cells; combining MAPK inhibitors with chemotherapy may enhance cell killing and leverage chemotherapy-induced immune microenvironment changes for better clearance.\n\nSmall studies and real-world data in refractory LCH support this: combination regimens yielded low relapse rates (especially with prolonged therapy), 100% responses in some pediatric cohorts with sustained remission and no added severe toxicity, and notably lower relapse (20% vs 75% with inhibitor alone) in our center's early experience with LCH-III backbone plus MAPK inhibitor.\n\nThis multicenter randomized trial will enroll children with multisystem LCH, assigning them to modified standard LCH-III chemotherapy alone or the same regimen combined with luvometinib, to evaluate whether adding this targeted agent improves outcomes.", 'detailedDescription': 'Lab studies show that when the MAPK pathway is overactive, it makes LCH cells harder to kill (more resistant to dying naturally). Combining an MAPK inhibitor with chemotherapy might make the abnormal cells easier to destroy. Chemotherapy also changes the immune environment in the body, which could help clear out the bad cells more completely.\n\nSeveral small studies and real-world experiences have already tested this idea in children and adults with hard-to-treat LCH:\n\nOne study combined MAPK inhibitors with certain chemotherapy drugs and saw very few relapses, especially when treatment lasted longer.\n\nAnother study using a similar approach achieved 100% response in a group of children (including some as first treatment), with most staying in remission afterward, and no extra serious side effects from the combination.\n\nA Chinese study using prednisone, another chemo drug, plus an MAPK inhibitor showed good results with low relapse after stopping.\n\nEarly data from our own center found that children who got an MAPK inhibitor together with the standard LCH-III treatment had much lower relapse rates (only 20%) compared to those who got the inhibitor alone (75% relapse).\n\nBased on this growing evidence, this study plans to run a large, carefully designed trial at multiple hospitals. It will randomly assign children with multisystem LCH to receive either the improved (modified) version of the standard LCH-III chemotherapy alone, or the same chemotherapy combined with luvometinib. The goal is to compare how well each approach works and to learn more about whether adding this targeted drug to chemotherapy can improve treatment for children with this disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '0 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Children aged 0-18 years, of either sex.\n2. Pathologically confirmed diagnosis of Langerhans cell histiocytosis (LCH) with positive staining for CD1a and/or CD207 (Langerin), and no prior treatment specifically directed against LCH.\n3. Multisystem involvement of LCH, as determined by clinical and imaging evaluation.\n4. Provision of written informed consent (by parent/legal guardian and, where appropriate, assent from the child), with willingness to comply with the study treatment regimen and follow-up assessments.\n\nExclusion Criteria:\n\n1. Presence of any other significant underlying medical condition, including but not limited to primary immunodeficiency disorders, congestive heart failure, renal insufficiency, chronic viral hepatitis, HIV infection, or status post solid organ transplantation.\n2. History of a second (secondary) malignancy.\n3. QTcF interval \\> 0.47 seconds on electrocardiogram performed prior to enrollment.\n4. Ophthalmologic screening prior to enrollment revealing retinal vein occlusion, retinal pigment epithelial detachment, or other clinically significant ocular abnormalities that, in the opinion of the investigator, contraindicate participation.\n5. LCH harboring Class 3 MEK pathway mutations, specifically the following alterations: L98\\_I103del, L98\\_K104del, P105\\_A106del, P105\\_I107delinsL, L101\\_I103delinsF, E102\\_I103delinsF, E102\\_I103del, E102\\_I103delinsV, E102\\_I103delinsVN, E102\\_K104delinsQ, or I103\\_A106del.\n6. Refusal or inability to provide written informed consent (or assent, as applicable).'}, 'identificationModule': {'nctId': 'NCT07431060', 'briefTitle': 'Modified LCH-III Regimen With or Without Luvometinib for Multisystem Pediatric Langerhans Cell Histiocytosis', 'organization': {'class': 'OTHER', 'fullName': 'West China Second University Hospital'}, 'officialTitle': 'Modified LCH-III Regimen Versus Modified LCH-III Regimen Combined With Luvometinib in the Treatment of Multisystem Pediatric Langerhans Cell Histiocytosis: A Multicenter, Open-Label, Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'WCSH-NCP-MS-LCH-2026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Modified LCH-III Chemotherapy + Luvometinib (Experimental Arm)', 'description': 'Participants receive the same modified LCH-III chemotherapy regimen (prednisone, vinblastine, mercaptopurine) combined with oral luvometinib throughout the treatment period', 'interventionNames': ['Drug: Prednisone', 'Drug: Vincristine', 'Drug: Mercaptopurine', 'Drug: Luvometinib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Modified LCH-III Chemotherapy Alone (Control Arm)', 'description': 'Participants receive the modified standard LCH-III chemotherapy regimen consisting of prednisone and vincristine.', 'interventionNames': ['Drug: Prednisone', 'Drug: Vincristine', 'Drug: Mercaptopurine']}], 'interventions': [{'name': 'Prednisone', 'type': 'DRUG', 'description': 'Corticosteroid administered orally as part of the modified LCH-III regimen', 'armGroupLabels': ['Modified LCH-III Chemotherapy + Luvometinib (Experimental Arm)', 'Modified LCH-III Chemotherapy Alone (Control Arm)']}, {'name': 'Vincristine', 'type': 'DRUG', 'description': 'Intravenous vinca alkaloid chemotherapy agent used in the modified LCH-III regimen', 'armGroupLabels': ['Modified LCH-III Chemotherapy + Luvometinib (Experimental Arm)', 'Modified LCH-III Chemotherapy Alone (Control Arm)']}, {'name': 'Mercaptopurine', 'type': 'DRUG', 'description': 'Oral purine analog antimetabolite used in the maintenance phase of therapy for multisystem LCH', 'armGroupLabels': ['Modified LCH-III Chemotherapy + Luvometinib (Experimental Arm)', 'Modified LCH-III Chemotherapy Alone (Control Arm)']}, {'name': 'Luvometinib', 'type': 'DRUG', 'description': 'Oral selective MEK1/2 inhibitor added to the experimental arm. Administered daily in combination with modified LCH-III chemotherapy for multisystem Langerhans cell histiocytosis.', 'armGroupLabels': ['Modified LCH-III Chemotherapy + Luvometinib (Experimental Arm)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chengdu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'XIa Guo', 'role': 'CONTACT', 'email': 'guoxkl@163.com', 'phone': '86+1818609112'}], 'facility': 'West China Second Hospital, Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Guiyang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiao Yan Yang', 'role': 'CONTACT', 'email': '469389553@qq.com', 'phone': '86+18786635712'}], 'facility': 'Affiliated Hospital of Guizhou Medical University', 'geoPoint': {'lat': 26.58333, 'lon': 106.71667}}, {'city': 'Hefei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hong Jun Liu', 'role': 'CONTACT', 'email': '13515657759@126.com', 'phone': '86+13515657759'}], 'facility': "Anhui Provincial Children's Hospital", 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'city': 'Hefei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jin Hua Chu', 'role': 'CONTACT', 'email': '997222161@qq.com', 'phone': '86+15805602655'}], 'facility': 'The Second Affiliated Hospital of Anhui Medical University', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'city': 'Jiangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chong Jun Wu', 'role': 'CONTACT', 'email': 'wuchongjunmed@163.com', 'phone': '86+13699560860'}], 'facility': "Jiangxi Provincial Children's Hospital", 'geoPoint': {'lat': 33.99934, 'lon': 105.19994}}, {'city': 'Kunming', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xin Tian', 'role': 'CONTACT', 'email': 'tianxin999@aliyun.com', 'phone': '86+13668757522'}], 'facility': "Kunming Children's Hospital", 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}, {'city': 'Nanning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hong Ying Wei', 'role': 'CONTACT', 'email': 'whylhr@qq.com', 'phone': '86+15977767103'}], 'facility': 'The Second Affiliated Hospital of Guangxi Medical University', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'city': 'Ürümqi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'MAIMAITI GULIBAHA', 'role': 'CONTACT', 'email': '156510283@qq.com', 'phone': '86+13070423745'}], 'facility': 'The First Affiliated Hospital of Xinjiang Medical University', 'geoPoint': {'lat': 43.80096, 'lon': 87.60046}}, {'city': "Xi'an", 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hua Wang', 'role': 'CONTACT', 'email': 'luoshake0219@163.com', 'phone': '86+18991236496'}], 'facility': "Xi'an Children's Hospital", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'city': "Xi'an", 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hui Liu', 'role': 'CONTACT', 'email': '15829655607@139.com', 'phone': '86+15829655607'}], 'facility': "Xi'an Northwest Women's and Children's Hospital", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'city': 'Zunyi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yan Chen', 'role': 'CONTACT', 'email': 'cyz600@163.com', 'phone': '86+13985261758'}], 'facility': "Zunyi Medical University Affiliated Hospital, Guizhou Provincial Children's Hospital", 'geoPoint': {'lat': 27.68667, 'lon': 106.90722}}], 'centralContacts': [{'name': 'Xue Tang', 'role': 'CONTACT', 'email': 'txily0912@126.com', 'phone': '86+18280145819'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD might be shared in the future upon approval by the ethics committee and under a data use agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West China Second University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pediatrics', 'investigatorFullName': 'Xia Guo', 'investigatorAffiliation': 'West China Second University Hospital'}}}}