Eneida R. Nemecek
A5034117075- CAR-T cell therapy research
- Hematopoietic Stem Cell Transplantation
- Acute Lymphoblastic Leukemia research
- Chronic Lymphocytic Leukemia Research
- Acute Myeloid Leukemia Research
- Hemoglobinopathies and Related Disorders
- Lymphoma Diagnosis and Treatment
- Childhood Cancer Survivors' Quality of Life
- Parvovirus B19 Infection Studies
- Biomedical Ethics and Regulation
- Viral-associated cancers and disorders
- Economic and Financial Impacts of Cancer
- Prenatal Screening and Diagnostics
- Mesenchymal stem cell research
- COVID-19 and healthcare impacts
- Virus-based gene therapy research
- Polyomavirus and related diseases
- Radiopharmaceutical Chemistry and Applications
- COVID-19 Clinical Research Studies
- Esophageal and GI Pathology
- Cytomegalovirus and herpesvirus research
- Cancer, Hypoxia, and Metabolism
- Chronic Myeloid Leukemia Treatments
- Immunodeficiency and Autoimmune Disorders
- Neuroblastoma Research and Treatments
Oregon Health & Science University
2015-2024
Doernbecher Children's Hospital
2011-2022
University of Portland
2007-2014
Children's Cancer Center
2014
Fred Hutch Cancer Center
2002-2003
Children's Hospital & Medical Center
2003
Cancer Research Center
2003
University of Washington
2003
Seattle Children's Hospital
2003
In a single-center phase 1-2a study, the anti-CD19 chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel produced high rates of complete remission and was associated with serious but mainly reversible toxic effects in children young adults relapsed or refractory B-cell acute lymphoblastic leukemia (ALL).We conducted 2, single-cohort, 25-center, global study pediatric adult patients CD19+ ALL. The primary end point overall rate (the incomplete hematologic recovery) within 3...
Severe steroid-refractory acute graft-versus-host disease (aGVHD) is related to significant mortality and morbidity after allogeneic stem cell transplantation. Early clinical trials of therapy with human mesenchymal cells (hMSCs) in pediatric patients severe aGVHD resistant multiple immunosuppressive agents showed promising results. In this study, we evaluated the risk/benefit profile remestemcel-L (Prochymal), a third-party, off-the-shelf source hMSCs, as rescue agent for...
Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary point, may be published when key planned co-primary or secondary analyses are not yet available. Trial Updates provide an opportunity to disseminate additional results from studies, in JCO elsewhere, for which point has already been reported. In analysis of global phase II ELIANA trial (ClinicalTrials.gov identifier: NCT02435849), tisagenlecleucel provided...
Steroid-refractory acute graft-versus-host disease (SR-aGVHD) following hematopoietic cell transplantation (HSCT) is associated with poor clinical outcomes. Currently, there are no safe and effective therapies approved for use in the pediatric population under age of 12 years. Accordingly, an urgent need new treatments that safe, well tolerated, managing this debilitating potentially fatal complication HSCT. In early phase trials, mesenchymal stromal cells (MSCs) have demonstrated efficacy...
BackgroundAdministration of anti-CD19 chimeric antigen receptor T-cell (CART19) immunotherapy for large B-cell lymphomas (LBCLs), a subset non-Hodgkin lymphoma (NHL), involves high costs and access to specialized tertiary care centers. We investigated whether minority health populations (MHPs) have equal CART19 their outcomes are similar those non-MHPs. MethodsWe analyzed the prevalence clinical patients treated with commercial at two geographically socioeconomically different institutions:...
Clinical outcomes in children with steroid-refractory acute graft-versus-host disease (SR-aGVHD) are generally poor, a high mortality rate and limited therapeutic options. Here we report our updated investigational experience mesenchymal stromal cell (MSC) therapy remestemcel-L multicenter expanded access protocol (ClinicalTrials.gov identifier NCT00759018) 241 aGVHD who failed to respond steroids or without other secondary tertiary immunosuppressive therapies. A total of grade B-D SR-aGVHD...
Patients with Epstein-Barr virus (EBV)-positive posttransplant lymphoproliferative disease (EBV+ PTLD) in whom initial treatment fails have few options and historically low median overall survival (OS) of 0.7 months after allogeneic hematopoietic cell transplant (HCT) 4.1 solid organ (SOT). Tabelecleucel is an off-the-shelf, EBV-specific cytotoxic T-lymphocyte immunotherapy for EBV+ PTLD. Previous single-center experience showed responses patients PTLD HCT or SOT. We now report outcomes from...
Voriconazole pharmacokinetics are not well characterized in children despite prior studies. To assess the appropriate pediatric dosing, a study was conducted 40 immunocompromised aged 2 to <12 years evaluate and safety of voriconazole following intravenous (IV)-to-oral (PO) switch regimens based on previous population pharmacokinetic modeling: 7 mg/kg IV every 12 h (q12h) 200 mg PO q12h. Area under curve over 12-h dosing interval (AUC(0-12)) calculated using noncompartmental method compared...
The interaction between common cardiovascular risk factors (CVRF) and hypertrophic cardiomyopathy (HCM) is poorly studied. We sought to explore the relation CVRF clinical characteristics of patients with HCM enrolled in EURObservational Research Programme (EORP) Cardiomyopathy registry.1739 were hypertension (HT), diabetes (DM), body mass index (BMI), traits was analysed. Analyses stratified according presence or absence a pathogenic variant sarcomere gene. prevalence HT, DM, obesity (Ob)...
Background: Pediatric and young adult pts with R/R B-ALL experience a treatment journey characterized by diminishing likelihood of cure increasing morbidity. Tisagenlecleucel is an autologous CD19-directed chimeric antigen receptor (CAR) T-cell therapy approved for use in pediatric adults B-cell lymphomas. provided high rates remission (>80%) children ELIANA, 62% responders remaining relapse-free at 24 mo (Grupp et al, Blood, 2018). Aims: Here, we report the final efficacy safety analyses...
ABSTRACT Voriconazole pharmacokinetics are not well characterized in children despite prior studies. To assess the appropriate pediatric dosing, a study was conducted 40 immunocompromised aged 2 to <12 years evaluate and safety of voriconazole following intravenous (IV)-to-oral (PO) switch regimens based on previous population pharmacokinetic modeling: 7 mg/kg IV every 12 h (q12h) 200 mg PO q12h. Area under curve over 12-h dosing interval (AUC 0–12 ) calculated using noncompartmental...
Hematopoietic cell transplantation (HCT) is effective in the treatment of inherited marrow failure disorders and other nonmalignant diseases. Conventional myeloablative conditioning regimens have been associated with high transplant-related mortality, particularly patients comorbid conditions. Here we report on 14 (Shwachman-Diamond syndrome, n = 3; Diamond Blackfan anemia, 4; GATA2 deficiency, 2; paroxysmal nocturnal hemoglobinuria, an undefined disorder, 1) who underwent HCT a prospective,...
Initial therapy of chronic graft-versus-host disease is prednisone ± a calcineurin-inhibitor, but most patients respond inadequately. In randomized, adaptive, phase II/III, multicenter trial we studied whether prednisone/sirolimus or prednisone/sirolimus/photopheresis was more effective than prednisone/sirolimus/calcineurin-inhibitor for treating in treatment-naïve early inadequate responders. Primary endpoints this study were proportions subjects alive without relapse secondary with 6-month...
We enrolled 150 patients in a prospective multicenter study of children with acute myeloid leukemia undergoing hematopoietic stem cell transplantation (HSCT) to compare the detection measurable residual disease (MRD) by "difference from normal" flow cytometry (ΔN) approach assessment Wilms tumor 1 (WT1) gene expression without access diagnostic specimen. Prospective analysis specimens using this showed that 23% screened for HSCT had detectable ΔN (.04% 53%). Of those who proceeded transplant...
Chronic graft-versus-host disease (cGVHD) is a potentially life-threatening complication of allogeneic hematopoietic stem cell transplantation. Clinical data surrounding cGVHD therapies in younger children are limited and critically needed. Primary endpoints were to determine the recommended pediatric equivalent dose (RPED) assess pharmacokinetics (PK) safety. Secondary included overall response rate (ORR; comprising complete partial response) according 2014 National Institutes Health...