{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T10:39:14Z","timestamp":1789641554855,"version":"4.0.0"},"reference-count":31,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"27","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["J Clin Oncol"],"published-print":{"date-parts":[[2026,9,20]]},"abstract":"<jats:sec>\n                    <jats:title>PURPOSE<\/jats:title>\n                    <jats:p>\n                      The Children's Oncology Group phase III clinical trial AAML1831 (ClinicalTrials.gov identifier:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT04293562\">NCT04293562<\/jats:ext-link>\n                      ) evaluated liposomal daunorubicin and cytarabine (CPX-351) versus standard daunorubicin\/cytarabine (DA) induction therapy in children and young adults with newly diagnosed AML. We hypothesized that CPX-351 given during induction 1 and 2 would improve outcomes compared with DA.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>PATIENTS AND METHODS<\/jats:title>\n                    <jats:p>Patients (21 years and younger) were randomly assigned to two cycles of DA induction (arm A = DA) or CPX-351 (arm B = CPX-351). All patients also received gemtuzumab ozogamicin in induction 1. Postinduction chemotherapy was according to risk assignment made at the end of induction 1 (EOI1). Those with high-risk (HR) AML received consolidation with allogeneic hematopoietic stem-cell transplantation (HSCT), whereas low-risk (LR) patients received chemotherapy alone. Protocol-specified interim analysis monitored efficacy and futility of CPX-351 induction with respect to the primary end point, event-free survival (EFS) from study entry. Disease-free survival (DFS) was calculated to determine the impact of EOI1 risk assignment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>\n                      Seven hundred twenty-one eligible patients with\n                      <jats:italic toggle=\"yes\">FLT3<\/jats:italic>\n                      wild-type AML were randomly assigned to DA (n = 358) or CPX-351 (n = 363). Interim analysis determined that the futility monitoring rule was crossed because of inferior EFS in the CPX-351 arm and the random assignment was stopped. The two-year EFS from study entry was 62.2% for DA versus 51.2% for CPX-351 (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      = .011). DFS for patients with HR AML was comparable for both arms. However, DFS was significantly lower and cumulative incidence of relapse (CIR) was higher for LR patients assigned to CPX-351 versus DA (2-year DFS from EOI1: DA: 73.8%\n                      <jats:italic toggle=\"yes\">v<\/jats:italic>\n                      CPX-351 57.5% [\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      = .001]; 2-year CIR Arm DA: 23.6%\n                      <jats:italic toggle=\"yes\">v<\/jats:italic>\n                      CPX-351: 39.9% [\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      = .001]).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSION<\/jats:title>\n                    <jats:p>CPX-351 was inferior to DA induction in the AAML1831 trial with differential EFS largely driven by events in LR patients.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1200\/jco-25-02979","type":"journal-article","created":{"date-parts":[[2026,7,24]],"date-time":"2026-07-24T20:00:53Z","timestamp":1784923253000},"page":"2590-2601","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":1,"title":["AAML1831: A Phase III Trial Comparing Standard Induction Therapy With CPX-351 in De Novo Pediatric AML: A Report From the Children's Oncology Group"],"prefix":"10.1200","volume":"44","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7307-9010","authenticated-orcid":false,"given":"Jessica A.","family":"Pollard","sequence":"first","affiliation":[{"name":"Department of Pediatrics, Dana Farber Cancer Institute\/Boston Children's Cancer and Blood Disorders Center, Harvard Medical School, Boston, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Todd A.","family":"Alonzo","sequence":"additional","affiliation":[{"name":"Univ. of Southern California Keck School of Medicine, Los Angeles, CA"},{"name":"Children's Oncology Group, Arcadia, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert B.","family":"Gerbing","sequence":"additional","affiliation":[{"name":"Children's Oncology Group, Arcadia, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew","family":"Kutny","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Betsy","family":"Hirsch","sequence":"additional","affiliation":[{"name":"University of Minnesota, Minneapolis, MN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gordana","family":"Raca","sequence":"additional","affiliation":[{"name":"Pathology and Laboratory Medicine, Children's Hospital Los Angeles, Los Angeles, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7905-6714","authenticated-orcid":false,"given":"Kasey","family":"Leger","sequence":"additional","affiliation":[{"name":"Division of Pediatric Hematology, Oncology, Bone Marrow Transplant &amp; 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