Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 10:41 PM
Study NCT ID:
NCT05711667
Status:
RECRUITING
Last Update Posted:
2025-12-22
First Post:
2023-01-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of the Drug Letermovir as Prevention of Cytomegalovirus Infection After Stem Cell Transplant in Pediatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'C000588473', 'term': 'letermovir'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 105}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2023-01-23', 'studyFirstSubmitQcDate': '2023-01-23', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Clinically significant CMV infection in early follow up', 'timeFrame': 'Up to 24 weeks post-transplant', 'description': 'Clinically significant CMV is defined as the first of (1) initiation of anti-CMV preemptive therapy for documented CMV DNAemia or (2) onset of CMV end-organ disease. Estimate cumulative incidence of clinically significant CMV at 24-weeks post-transplant by study arm and will report corresponding 95% confidence intervals.'}, {'measure': 'Clinically significant CMV infection in late follow up', 'timeFrame': 'Up to 48 weeks post-transplant', 'description': 'Clinically significant CMV is defined as the first of (1) initiation of anti-CMV preemptive therapy for documented CMV DNAemia or (2) onset of CMV end-organ disease. Estimate cumulative incidence of clinically significant CMV at 48-weeks post-transplant by study arm and will report corresponding 95% confidence intervals.'}, {'measure': 'Overall survival (OS) in early follow up', 'timeFrame': 'Up to 24 weeks post transplant', 'description': 'The Kaplan-Meier method will be used to estimate 24-week OS by study arm, as defined by time from transplant until death. Corresponding 95% confidence intervals will be reported.'}, {'measure': 'Overall survival (OS) in late follow up', 'timeFrame': 'Up to 48 weeks post-transplant', 'description': 'The Kaplan-Meier method will be used to estimate 48-week OS by study arm, as defined by time from transplant until death. Corresponding 95% confidence intervals will be reported.'}, {'measure': 'Neutrophil engraftment', 'timeFrame': 'Up to 60 days post-transplant', 'description': 'Engraftment is defined as the first three days of neutrophil count values above 500 cells/μL. Estimate cumulative incidence of neutrophil engraftment at 60-days post-transplant by study arm and will report corresponding 95% confidence intervals.'}, {'measure': 'Incidence of neutropenia', 'timeFrame': 'Up to 14 weeks post-transplant', 'description': 'Neutropenia will be defined as an absolute neutrophil count \\< 500 cells/uL. Estimate the median number of weeks of neutropenia by arm study.'}, {'measure': 'Incidence of acute kidney injury', 'timeFrame': 'Up to 52 weeks post-transplant', 'description': 'Acute kidney injury will be defined as grade 3 or higher creatinine elevation using the common terminology criteria for adverse events (CTCAE) v5 definitions. Estimate cumulative incidence of acute kidney injury at 52-weeks post-transplant by study arm and will report corresponding 95% confidence intervals.'}, {'measure': 'Incidence of chronic kidney disease', 'timeFrame': 'Up to 52 weeks post transplant', 'description': 'Chronic kidney disease outcome will be defined as grade 2 or higher using the CTCAE v5 definitions. Estimate cumulative incidence of chronic kidney disease at 52-weeks post-transplant by study arm and will report corresponding 95% confidence intervals.'}, {'measure': 'Number of inpatient hospital days', 'timeFrame': 'Up to 14 weeks post-transplant', 'description': 'Estimate the median number of inpatient hospital days by study arm.'}, {'measure': 'Number of inpatient hospital days', 'timeFrame': 'Up to one-year post-transplant', 'description': 'Estimate the median number of inpatient hospital days by study arm.'}, {'measure': 'Incidence of resistance to antiviral medications', 'timeFrame': 'Up to 14 weeks post-transplant', 'description': 'Estimate the cumulative incidence of resistance to antiviral medications by study arm among the patients who develop clinically significant CMV infection. This analysis will be restricted to patients with viral loads \\> 1000 IU/mL.'}, {'measure': 'CD4+ lymphocyte count', 'timeFrame': 'Up to 14 weeks post-transplant', 'description': 'Estimate the median CD4+ lymphocyte count by study arm'}, {'measure': 'CD4+ lymphocyte count', 'timeFrame': 'Up to 24 weeks post-transplant', 'description': 'Estimate the median CD4+ lymphocyte count by study arm.'}, {'measure': 'CD4+ lymphocyte count', 'timeFrame': 'Up to 48 weeks post-transplant', 'description': 'Estimate the median CD4+ lymphocyte count by study arm.'}, {'measure': 'CD8+ lymphocyte count', 'timeFrame': 'Up to 14 weeks post-transplant', 'description': 'Estimate the median CD4+ lymphocyte count by study arm.'}, {'measure': 'CD8+ lymphocyte count', 'timeFrame': 'Up to 24 weeks post-transplant', 'description': 'Estimate the median CD4+ lymphocyte count by study arm.'}, {'measure': 'CD8+ lymphocyte counts', 'timeFrame': 'Up to 48 weeks post-transplant', 'description': 'Estimate the median CD4+ lymphocyte count by study arm.'}], 'primaryOutcomes': [{'measure': 'Clinically significant cytomegalovirus (CMV) infection', 'timeFrame': 'Up to week 14 post-transplant', 'description': 'Clinically significant CMV is defined as the first of (1) initiation of anti-CMV preemptive therapy for documented CMV DNAemia or (2) onset of CMV end-organ disease. Estimate cumulative incidence of clinically significant CMV at 14-weeks post-transplant by study arm and will report corresponding 95% confidence intervals.'}], 'secondaryOutcomes': [{'measure': 'Detection of CMV DNAemia', 'timeFrame': 'Up to week 14 post transplant', 'description': 'Estimate cumulative incidence of CMV DNAemia at 14-weeks post-transplant by study arm and will report corresponding 95% confidence intervals.'}, {'measure': 'CMV-free survival', 'timeFrame': 'Up to 24 weeks post transplant', 'description': 'Among transplanted patients with a negative plasma CMV PCR between day -7 and day of transplant, estimate cumulative incidence of the occurrence of CMV DNAemia or death by week 24 post-transplant by study arm and will report corresponding 95% confidence intervals.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hematopoietic and Lymphoid Cell Neoplasm', 'Malignant Solid Neoplasm']}, 'descriptionModule': {'briefSummary': 'This phase III trial determines whether taking prophylactic letermovir will reduce the likelihood of infection with cytomegalovirus (CMV) in children and adolescents after stem cell transplant. The treatments used to prepare for HCT reduce the body\'s natural infection-fighting ability and increase the likelihood of an infection with a virus called cytomegalovirus. "Prophylaxis" means to take a drug to prevent a disease or side effect. Letermovir is an antiviral drug that stops cytomegalovirus from multiplying and may prevent cytomegalovirus infection and make the disease less severe.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To evaluate the efficacy of letermovir prophylaxis in the prevention of clinically significant CMV infection through Week 14 (\\~100 days) post-transplant in children and adolescents receiving allogeneic hematopoietic cell transplant (allo-HCT).\n\nSECONDARY OBJECTIVE:\n\nI. To evaluate the efficacy of letermovir prophylaxis as assessed by CMV-free survival through 24 weeks (\\~6 months) post-transplant in pediatric patients.\n\nEXPLORATORY OBJECTIVES:\n\nI. To evaluate the incidence of clinically significant CMV infection through 24 and 52 weeks post-transplant in patients who receive letermovir prophylaxis.\n\nII. To evaluate overall survival post-transplant in patients who receive letermovir prophylaxis.\n\nIII. To evaluate time to engraftment and describe the cumulative incidence of non-engraftment among patients who receive letermovir.\n\nIV. To examine the following clinically significant adverse events among patients exposed to letermovir: the total duration of neutropenia through week 14 (\\~100 days) post-transplant, the cumulative incidence of acute kidney injury and chronic kidney disease by 52 weeks post-transplant, and total inpatient hospital days by 14 weeks (\\~100 days) and 52 weeks post-transplant.\n\nV. Describe patterns of anti-viral resistance at the onset of CMV DNAemia after allo-HCT among patients who receive letermovir prophylaxis.\n\nVI. To describe immune reconstitution and CMV-specific immunity among patients who receive letermovir prophylaxis.\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM A: Patients receive letermovir orally (PO) or intravenously (IV) over 60 minutes once daily (QD) starting on day +1 post-transplant for 14 weeks. Patients undergo collection of blood samples for CMV polymerase chain reaction (PCR) analysis weekly for 14 weeks, every 2 weeks until week 24, week 32, week 40 and week 52.\n\nARM B: Patients undergo collection of blood samples for CMV PCR analysis weekly for 14 weeks, every 2 weeks until week 24, week 32, week 40 and week 52.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* \\>= 2 years and \\< 18 years at the time of enrollment\n* Weight must be \\>= 18 kg. For patients \\< 12 years of age and expected to receive cyclosporine, weight must be \\>= 30kg\n* Planned allogeneic HCT (bone marrow, peripheral blood stem cell, or cord blood transplant)\n* Patient must be CMV sero-positive (i.e., recipient CMV immunoglobulin G positive)\n* Patient is eligible for entry only if it is feasible for plasma CMV PCR testing to be sent and resulted within the protocol mandated time period\n\n * Reminder: To limit the likelihood of positive plasma CMV PCR post-enrollment and prior to start of study treatment period, it is recommended that patient enrollment proceed after patients start their transplant preparative regimen\n* Patient must have a performance status corresponding to Lansky/Karnofsky scores \\> 50\n\n * Note: Use Lansky for patients =\\< 16 years of age and Karnofsky for patients \\> 16 years of age. For further reference, see performance status scales scoring under the standard sections for protocols among protocol reference materials provided on the Children's Oncology Group (COG) member website: https://members.childrensoncologygroup.org/prot/reference\\_materials.asp\n* Estimated glomerular filtration rate \\> 15 mL/min/1.73 m\\^2 and not receiving dialysis\n* Total bilirubin =\\< 2.5 mg/dL and serum glutamate-pyruvate transaminase (SPGT) (alanine transaminase \\[ALT\\]) =\\<10 x upper limit of normal (ULN) for age\n\n * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L\n\nExclusion Criteria:\n\n* Expected inability to tolerate oral formulation (e.g., unable swallow whole tablets) of letermovir\n\n * Note: Determination of ability to tolerate the oral formulation will be based on a self-assessment or caregiver assessment; eligible subjects and their caregiver will be shown a life size picture of a tablet (or actual tablet) and confirm ability to swallow whole tablet in order to meet study eligibility\n* Hypersensitivity to letermovir or any component of the formulation\n* History of CMV end organ disease within 6 months (180 days) prior to enrollment\n\n * Note: CMV end organ disease based on proposed definitions by Ljungman et al. and inclusive of proven, probable or possible disease\n* Receipt of prior allogeneic HCT within one year of study enrollment\n* Planned prophylactic administration of other anti-CMV medications or cellular products during the study, including:\n\n * High dose acyclovir (defined as doses \\>= 1500 mg/m\\^2 IV or \\>= 3200 mg oral (patients \\>= 40 kg) or \\>= 2400 mg/m\\^2 (patients \\< 40 kg) per day)\n * High dose valacyclovir (defined as doses \\>= 3000 mg/day in patients \\> 20 kg)\n * Foscarnet\n * Ganciclovir\n * Valganciclovir\n * CMV-directed cytotoxic T lymphocytes\n* Planned receipt of the following contraindicated medications during the study treatment period; contraindicated medications must be discontinued at least 14 days prior to Day +1\n\n * Contraindicated medications for all patients:\n\n * Pimozide\n * Ergot alkaloids\n * Contraindicated medications for patients planned to receive cyclosporine:\n\n * Bosentan\n * Lovastatin\n * Pitavastatin\n * Rosuvastatin\n * Simvastatin\n* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted in certain animal reproduction studies with letermovir. A pregnancy test is required for female patients of childbearing potential\n* Lactating females who plan to breastfeed their infants\n* Sexually active female patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their letermovir treatment and through at least 4 weeks after the last dose of letermovir.\n\n * Note: No contraception measures are needed specifically during letermovir treatment for male trial participants who have pregnant or non-pregnant female partner(s) of reproductive potential. Contraception measures may be required for other aspects of the HCT procedure.\n* All patients and/or their parents or legal guardians must sign a written informed consent\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met"}, 'identificationModule': {'nctId': 'NCT05711667', 'briefTitle': 'A Study of the Drug Letermovir as Prevention of Cytomegalovirus Infection After Stem Cell Transplant in Pediatric Patients', 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': 'Letermovir Prophylaxis for Cytomegalovirus in Pediatric Hematopoietic Cell Transplantation', 'orgStudyIdInfo': {'id': 'ACCL1932'}, 'secondaryIdInfos': [{'id': 'NCI-2022-10769', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'ACCL1932', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'COG-ACCL1932', 'type': 'OTHER', 'domain': 'DCP'}, {'id': 'ACCL1932', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U24CA196173', 'link': 'https://reporter.nih.gov/quickSearch/U24CA196173', 'type': 'NIH'}, {'id': 'UG1CA189955', 'link': 'https://reporter.nih.gov/quickSearch/UG1CA189955', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ARM I (Letermovir prophylaxis)', 'description': 'Patients receive letermovir PO or IV over 60 minutes QD starting on day +1 post-transplant for 14 weeks. Patients undergo collection of blood samples for CMV PCR analysis weekly for 14 weeks, every 2 weeks until week 24, week 32, week 40 and week 52.', 'interventionNames': ['Procedure: Biospecimen Collection', 'Drug: Letermovir']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ARM II (No prophylaxis)', 'description': 'Patients undergo collection of blood samples for CMV PCR analysis weekly for 14 weeks, every 2 weeks until week 24, week 32, week 40 and week 52.', 'interventionNames': ['Procedure: Biospecimen Collection']}], 'interventions': [{'name': 'Biospecimen Collection', 'type': 'PROCEDURE', 'otherNames': ['Biological Sample Collection', 'Biospecimen Collected', 'Specimen Collection'], 'description': 'Undergo collection of blood samples', 'armGroupLabels': ['ARM I (Letermovir prophylaxis)', 'ARM II (No prophylaxis)']}, {'name': 'Letermovir', 'type': 'DRUG', 'otherNames': ['2-((4S)-8-Fluoro-2-(4-(3-methoxyphenyl)piperazin-1-yl)-3-(2-methoxy-5-(trifluoromethyl)phenyl)-4H-quinazolin-4-yl)acetic Acid', 'AIC246', 'MK-8228', 'Prevymis'], 'description': 'Given PO or IV', 'armGroupLabels': ['ARM I (Letermovir prophylaxis)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'oncologyresearch@peds.uab.edu', 'phone': '205-638-9285'}, {'name': 'Joseph H. Chewning', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Hospital of Alabama", 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '94609', 'city': 'Oakland', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'PedOncRschOAK@ucsf.edu', 'phone': '510-428-3264'}, {'name': 'Jennifer G. Michlitsch', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "UCSF Benioff Children's Hospital Oakland", 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'cancertrials@ucsf.edu', 'phone': '877-827-3222'}, {'name': 'Christopher C. Dvorak', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UCSF Medical Center-Mission Bay', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '19803', 'city': 'Wilmington', 'state': 'Delaware', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'Allison.bruce@nemours.org', 'phone': '302-651-5572'}, {'name': 'Scott M. Bradfield', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Alfred I duPont Hospital for Children', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'Allison.bruce@nemours.org', 'phone': '302-651-5572'}, {'name': 'Scott M. Bradfield', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Nemours Children's Clinic-Jacksonville", 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'phone': '800-237-1225'}, {'name': 'Rajat Sharma', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Iowa/Holden Comprehensive Cancer Center', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'CancerResource@nortonhealthcare.org', 'phone': '502-629-5500'}, {'name': 'Michael J. Ferguson', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Norton Children's Hospital", 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '70118', 'city': 'New Orleans', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'phone': '504-894-5377'}, {'name': 'Maria C. Velez-Yanguas', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Hospital New Orleans", 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'jhcccro@jhmi.edu', 'phone': '410-955-8804'}, {'name': 'Heather J. Symons', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Johns Hopkins University/Sidney Kimmel Cancer Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'helpdesk@childrensoncologygroup.org'}, {'name': 'Erin Goode', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Hospital of Michigan", 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'crcwm-regulatory@crcwm.org', 'phone': '616-391-1230'}, {'name': 'Kathleen Y. Butler', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital", 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'status': 'SUSPENDED', 'country': 'United States', 'facility': "Children's Mercy Hospitals and Clinics", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'CancerTrials@email.chop.edu', 'phone': '267-425-5544'}, {'name': 'Caitlin W. Elgarten', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'referralinfo@stjude.org', 'phone': '888-226-4343'}, {'name': 'Diego R. Hijano', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Saint Jude Children's Research Hospital", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'phone': '615-342-1919'}, {'name': 'Clinton M. Carroll', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "The Children's Hospital at TriStar Centennial", 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'phone': '972-566-5588'}, {'name': 'Maurizio L. Ghisoli', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical City Dallas Hospital', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'canceranswerline@UTSouthwestern.edu', 'phone': '214-648-7097'}, {'name': 'Victor M. Aquino', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UT Southwestern/Simmons Cancer Center-Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'burton@bcm.edu', 'phone': '713-798-1354'}, {'name': 'Anil George', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'Vinod.GidvaniDiaz@hcahealthcare.com', 'phone': '210-575-6240'}, {'name': 'Jose M. Esquilin', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Methodist Children's Hospital of South Texas", 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84113', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'phone': '801-585-5270'}, {'name': 'Soohee Cho', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Primary Children's Hospital", 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'CTOclinops@vcu.edu', 'phone': '804-628-6430'}, {'name': 'Elizabeth Krieger', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'VCU Massey Comprehensive Cancer Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'clinicaltrials@cancer.wisc.edu', 'phone': '800-622-8922'}, {'name': 'Michael J. Eckrich', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Wisconsin Carbone Cancer Center - University Hospital', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Caitlin W Elgarten', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Oncology Group"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Oncology Group", 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}