[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100406285":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":38,"centralContacts":39,"locations":45,"responsibleParty":96,"collaborators":38,"id":98,"slug":38,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":38,"eligibilityCriteria":103,"healthyVolunteers":99,"sex":104,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":38,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":117,"overallStatus":77,"whyStopped":38,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Spectrum Pharmaceuticals, Inc","INDUSTRY",[8,15,19,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1: ≥12 to \u003C17 years","EXPERIMENTAL","Participants will receive a SC injection of eflapegrastim after completion of each cycle of chemotherapy up to four cycles of treatment (cycle length may vary and can be up to 28 days or more based on the type of chemotherapy regimen selected).",[13,14],"Drug: Eflapegrastim","Drug: Chemotherapy",{"label":16,"type":10,"description":17,"interventionNames":18},"Cohort 2: ≥6 to \u003C12 years","Participants will receive a SC injection eflapegrastim after completion of each cycle of chemotherapy up to four cycles of treatment (cycle length may vary and can be up to 28 days or more based on the type of chemotherapy regimen selected).",[13,14],{"label":20,"type":10,"description":17,"interventionNames":21},"Cohort 3: ≥2 to \u003C6 years",[13,14],{"label":23,"type":10,"description":17,"interventionNames":24},"Cohort 4: ≥1 month to \u003C2 years",[13,14],[26,34],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Eflapegrastim","Eflapegrastim supplied in prefilled, single-use syringes for SC injection.",[9,16,20,23],[32,33],"Rolontis®","SPI-2012",{"type":27,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"Chemotherapy","Chemotherapy agents may include doxorubicin, ifosfamide, docetaxel, CHOP regimen, etoposide, cyclophosphamide and vincristine which will be administered as per standard of care per the Primary Care physician's treatment plan.",[9,16,20,23],null,[40],{"name":41,"role":42,"phone":43,"phoneExt":38,"email":44},"Howard Franklin, MD","CONTACT","224.419.7106","Hfranklin@assertiotx.com",[46,60,70,75,86],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":38},"New York Medical College","TERMINATED","Valhalla","New York","10595","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-73.77513,41.07482,{"lat":58,"lon":57},{"facility":61,"status":48,"city":62,"state":63,"zip":64,"country":52,"countryCode":53,"cosmosGeoPoint":65,"geoPoint":69,"contacts":38},"Carolinas Medical Center\u002F Levine Children's Hospital","Charlotte","North Carolina","28203",{"type":55,"coordinates":66},[67,68],-80.84313,35.22709,{"lat":68,"lon":67},{"facility":71,"status":48,"city":62,"state":63,"zip":64,"country":52,"countryCode":53,"cosmosGeoPoint":72,"geoPoint":74,"contacts":38},"Levine Children's Health",{"type":55,"coordinates":73},[67,68],{"lat":68,"lon":67},{"facility":76,"status":77,"city":78,"state":79,"zip":80,"country":52,"countryCode":53,"cosmosGeoPoint":81,"geoPoint":85,"contacts":38},"University Hospitals Cleveland Medical Center","RECRUITING","Cleveland","Ohio","44106",{"type":55,"coordinates":82},[83,84],-81.69541,41.4995,{"lat":84,"lon":83},{"facility":87,"status":48,"city":88,"state":89,"zip":90,"country":52,"countryCode":53,"cosmosGeoPoint":91,"geoPoint":95,"contacts":38},"UT MD Anderson Cancer Center","Houston","Texas","77030",{"type":55,"coordinates":92},[93,94],-95.36327,29.76328,{"lat":94,"lon":93},{"type":97,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100406285",false,"NCT04570423","A Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Participants With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy","A Multicenter, Open-Label, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Patients With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy","Inclusion Criteria:\n\n1. Participant must have a pathologic\u002Fhistologic confirmed newly diagnosed\u002Frelapsed\u002Frecurrent solid tumor or lymphoma without bone marrow involvement.\n2. Participant must be a candidate to receive myelosuppressive chemotherapy, with a febrile neutropenia rate of at least 20% as outlined in the National Comprehensive Cancer Network (NCCN) guidelines.\n3. Participant has adequate hematological, renal, and hepatic function.\n4. Participant must have an echocardiogram (ECHO) or multigated acquisition (MUGA) within 14 days of Screening if receiving a cardiotoxic therapy and have a cardiac ejection fraction of \\>50%.\n5. Participant must have a lumbar puncture, if clinically indicated, to rule out central nervous system (CNS) involvement within 14 days of study entry.\n6. Participant has a Karnofsky performance level ≥50% for patients ≥16 years of age or a Lansky performance level ≥50 for children \\\u003C16 years of age.\n\nExclusion Criteria:\n\n1. Participant has an uncontrollable infection, has an underlying medical condition, and\u002For another serious illness that would impair the ability of the participant to receive protocol-specified treatment.\n2. Participant has had previous exposure to filgrastim (within 7 days), pegfilgrastim (within 14 days), or other granulocyte colony stimulating factor (G-CSF) products in clinical development within 2 weeks prior to the administration of study drug (eflapegrastim)\n3. Participant requires concurrent radiation therapy specifically in Cycle 1.\n4. Participant has had prior bone marrow or hematopoietic stem cell transplant and\u002For has concurrent bone marrow involvement in their malignancy, including leukemia.\n5. Participant has had spinal radiation therapy within 30 days prior to study enrollment.\n6. Participant has used any investigational drugs, biologics or devices within 30 days prior to study treatment or plans to use any of these during the study.\n7. Participant has a known sensitivity or previous reactions to any of the G-CSF products.\n8. Participant with active CNS disease.\n9. Participant has not recovered from previous treatment adverse events to ≤Grade 1.","ALL","1 Month","17 Years",{"count":108,"type":109},40,"ESTIMATED","INTERVENTIONAL",[112],"PHASE2","The purpose of this study is to evaluate the safety and pharmacokinetics of eflapegrastim in pediatric participants with solid tumors or lymphoma and treated with myelosuppressive chemotherapy.",[115,116],"Solid Tumors","Lymphoma",[118,115,35],"Lymphomas","2026-06-23",{"date":121,"type":122},"2026-06-24","ACTUAL",{"date":124,"type":122},"2021-05-20",{"date":126,"type":109},"2027-10",{"name":5,"class":6},5]