Corresponding Author: Patrick A. Brown, MD, Department of Oncology, Johns Hopkins University School of Medicine, 1650 Orleans St, CRB1 Room 2M51, Baltimore, MD 21287 (firstname.lastname@example.org).
Accepted for Publication: January 16, 2021.
Author Contributions: Drs Brown and Ji had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Drs Hunger and Loh are co–senior authors.
Concept and design: Brown, Ji, Devidas, Borowitz, Raetz, Zugmaier, Sharon, Bernhardt, Terezakis, Gore, Whitlock, Pulsipher, Hunger, Loh.
Acquisition, analysis, or interpretation of data: Brown, Xu, Devidas, Hogan, Borowitz, Sharon, Gore, Pulsipher, Hunger, Loh.
Drafting of the manuscript: Brown, Ji, Xu, Devidas, Sharon, Pulsipher, Hunger.
Critical revision of the manuscript for important intellectual content: Brown, Hogan, Borowitz, Raetz, Zugmaier, Sharon, Bernhardt, Terezakis, Gore, Whitlock, Pulsipher, Hunger, Loh.
Statistical analysis: Brown, Ji, Xu, Devidas.
Obtained funding: Borowitz, Sharon.
Administrative, technical, or material support: Brown, Borowitz, Sharon, Bernhardt, Gore, Pulsipher, Hunger, Loh.
Supervision: Brown, Raetz, Zugmaier, Sharon, Terezakis, Gore, Whitlock, Pulsipher, Loh.
Other - patient contribution: Gore.
Conflict of Interest Disclosures: Dr Brown reported receiving personal fees from serving on scientific advisory committees for Novartis, Kura, Kite, Amgen, Servier, Jazz Pharmaceuticals, and Janssen outside the submitted work. Dr Borowitz reported providing consultancy for Amgen and receiving honoraria from Beckman Coulter. Dr Raetz reported receiving research funding from Pfizer and serving on a data and safety monitoring board for Celgene outside the submitted work. Dr Zugmaier reported receiving personal fees from Amgen for employment outside the submitted work and having patents pending (10696744, 10662243, 20190142846, 20190127465, 10130638, 20170327581, 9688760, 20170122947, 9486475, 20160208001, 9192665, 20150071928, 8840888, 20140228316, 20140227272, 20130287778, 20130287774, 20100112603, and 7700299) and issued (20190300609, 20110262440, and 20130323247). Dr Bernhardt reported receiving grants from Celgene and Bristol Myers Squibb and personal fees from Servier and Mesoblast outside the submitted work. Dr Terezakis reported receiving grants from ASELL outside the submitted work. Dr Gore reported providing consultancy for Amgen, Novartis, and Roche/Genentech; having equity ownership in Amgen, Blueprint Medicines, Celgene, Clovis, Mirati, and Sanofi Paris; receiving honoraria from Amgen and Roche/Genentech; and serving on a scientific advisory committee for Amgen and data safety and monitoring committees for Novartis and Celgene. Dr Whitlock reported receiving personal fees from Amgen honorarium for consulting outside the submitted work. Dr Pulsipher reported serving on scientific advisory committees for Novartis, Adaptive, and CSL Behring; providing consultancy for Novartis, Jazz Pharmaceuticals, Bellicum Pharmaceuticals, and Mesoblasta; and receiving research funding from Adaptive and Miltenyi and honoraria from Amgen and Medac. Dr Hunger reported consulting for Amgen, Bristol Myers Squibb, and Novartis; having equity ownership in Amgen; and receiving honoraria from Jazz Pharmaceuticals outside the submitted work. Dr Loh reported serving on a scientific advisory committee for MediSix Therapeutics outside the submitted work. No other disclosures were reported.
Funding/Support: This clinical trial was funded by grants from the National Institutes of Health/National Cancer Institute (National Clinical Trials Network Operations Center grant U10CA180886 and National Clinical Trials Network Statistics and Data Center grant U10CA180899) and the St Baldrick’s Foundation. Blinatumomab was provided to study participants by Amgen via a Collaborative Research and Development Agreement with the National Institutes of Health/National Cancer Institute/Cancer Therapy and Evaluation Program.
Role of the Funder/Sponsor: The Children’s Oncology Group investigators designed the trial. The National Cancer Institute (NCI) Cancer Therapy Evaluation Program, Amgen, and the US Food and Drug Administration reviewed the trial, made recommendations for changes, and approved the final trial design. All amendments were reviewed and approved by the NCI and Amgen. The Children’s Oncology Group investigators conducted the trial and performed the collection, management, analysis, and interpretation of the data. The first and second authors (P.A.B. and L.J.) prepared the manuscript. All authors, the NCI, and Amgen reviewed and approved the manuscript. The decision to submit the manuscript for publication was made by the authors.
Data Sharing Statement: See Supplement 3.
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