Corresponding Author: Franco Locatelli, MD, PhD, Sapienza, University of Rome, Department of Pediatric Hematology and Oncology, IRCCS Ospedale Pediatrico Bambino Gesù, Piazza Sant'Onofrio, 4, 00165 Rome, Italy (franco.locatelli@opbg.net).
Accepted for Publication: January 22, 2021.
Author Contributions: Dr Locatelli 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.
Concept and design: Locatelli, Zugmaier, Morris, Parasole, Micalizzi, Mergen, Peters, Saha, von Stackelberg.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Locatelli, Zugmaier, Morris, Parasole, Mergen, Peters, Saha, von Stackelberg.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Zugmaier, Mohammad.
Administrative, technical, or material support: Morris, Gruhn, Klingebiel, Petit, Eckert, Möricke, Sartor, Saha, von Stackelberg.
Supervision: Locatelli, Zugmaier, Morris, Parasole, Mergen, Eckert, Saha, von Stackelberg.
Contribution to statistical sections of manuscript and revisions/suggestions: Mohammad.
Recruitment of cases, collecting data and information, discussing management of patients, evaluating results: Rizzari.
Conflict of Interest Disclosures: Dr Locatelli reports receiving personal fees from Amgen Speakers' Bureau and advisory board membership, Novartis Speakers' Bureau and advisory board membership, Bellicum Pharmaceuticals advisory board membership, Miltenyi Speakers' Bureau, Jazz Pharmaceutical Speakers' Bureau, Takeda Speakers' Bureau, Neovii advisory board membership, and Medac Speakers' Bureau outside the submitted work. Dr Zugmaier reports receiving personal fees from Amgen outside the submitted work, receiving issue of patents (20190300609, 20130323247, and 20110262440), and having patents pending (10696744, 10662243, 20190142846, 20190142846, 20170327581, 10130638, 9688760, 20170122947, 9486475, 20160208001, 9192665, 20150071928, 8840888, 20140228316, 20140227272, 20130287778, and 20130287774). Dr Rizzari reports receiving personal fees from SOBI Advisory Board during the conduct of the study. Dr Morris reports receiving personal fees from Amgen employee during the conduct of the study and personal fees from and employment at Amgen. Dr Klingebiel reports receiving grants from Amgen GmbH during the conduct of the study. Dr Mergen reports employment by Amgen Research (Munich) GmbH. Ms Mohammad reports being an employee and shareholder of Amgen Ltd. Dr Eckert reports receiving other from Amgen Service for central minimal residual disease quantification during the conduct of the study. Dr Möricke reports receiving other from Amgen Payments to the institution for laboratory work during the conduct of the study. Dr Sartor reports receiving grants from Amgen during the conduct of the study. Dr Hrusak reports receiving grants from Amgen covering costs of minimal residual disease monitoring by cytometry during the conduct of the study. Dr Peters reports receiving personal fees from Amgen during the conduct of the study; grants from Amgen, Medac, Neovii, and Riemser outside the submitted work; and personal fees from Novartis, Amgen, and Jazz outside the submitted work. Dr Saha reports receiving personal fees from Amgen during the conduct of the study. Dr von Stackelberg reports receiving personal fees from Amgen Advisory Board during the conduct of the study and personal fees from Novartis Advisory Board, MorphoSys Advisory Board, Jazz Pharmaceuticals Advisory Board, and Shire Advisory Board outside the submitted work. No other disclosures were reported.
Funding/Support: This study was funded by Amgen Inc.
Role of the Funder/Sponsor: Amgen Inc participated in the conception, design, and conduct of the trial and the analysis and interpretation of data; managed patient data collected at the study sites; and supported the external authors in submitting the results of this clinical trial for publication in JAMA in parallel with the publication of Study AALL1331 from the Children’s Oncology Group. Amgen did not control the decision. Amgen did not have the right to veto publication or to control the decision regarding to which journal the manuscript was submitted.
Group Information: A complete list of principal investigators is provided in the eAppendix in Supplement 3.
Data Sharing Statement: See Supplement 4.
Additional Contributions: Medical writing support was provided by Kathryn Boorer, PhD, of KB Scientific Communications, LLC, funded by Amgen Inc; and Liz Leight, PhD, an employee of Amgen Inc.