{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,7]],"date-time":"2026-07-07T22:25:51Z","timestamp":1783463151735,"version":"3.55.0"},"reference-count":35,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2026,5,18]],"date-time":"2026-05-18T00:00:00Z","timestamp":1779062400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,5,18]],"date-time":"2026-05-18T00:00:00Z","timestamp":1779062400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pediatric Blood &amp; Cancer"],"published-print":{"date-parts":[[2026,8]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Mitoxantrone hydrochloride liposome (Lipo\u2010MIT), an innovative anthracycline nano\u2010drug, has demonstrated a favorable pharmacokinetics (PK) profile in lymphoma and preliminary efficacy in adult acute myeloid leukemia (AML). This study investigated the PK profile, efficacy, and safety of Lipo\u2010MIT plus cytarabine in newly diagnosed pediatric AML.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In this single\u2010arm, open\u2010label trial, eligible patients received Lipo\u2010MIT and cytarabine every 4\u00a0weeks for two cycles. The primary endpoint was the PK characteristics of Lipo\u2010MIT after the first dose.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Between July 19, 2023, and November 14, 2023, eight pediatric patients were enrolled. The total and free mitoxantrone concentrations increased rapidly during the absorption phase and then declined gradually to minimal concentrations before the administration of the second dose. The mean elimination half\u2010life of total mitoxantrone was 60.2 \u00b1 9.4\u00a0h, and the ratio of the area under the plasma concentration\u2013time curve from Time 0 to the time of the last quantifiable concentration (AUC\n                      <jats:sub>0\u2010<\/jats:sub>\n                      <jats:italic>\n                        <jats:sub>t<\/jats:sub>\n                      <\/jats:italic>\n                      ) of free mitoxantrone to total mitoxantrone was 1.8% \u00b1 0.6%. The overall response rate and composite complete remission rate were both 85.7% (6\/7). Measurable residual disease negativity was achieved in four (66.7%) patients after Cycle 1 and in six (100.0%) after Cycle 2. The 1\u2010year relapse\u2010free survival rate was 83.3%. The common Grade \u22653 treatment\u2010related adverse events were hematological toxicities (100.0%) and soft tissue infection (28.6%). No treatment\u2010related deaths occurred.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Lipo\u2010MIT plus cytarabine showed a favorable PK profile and a manageable safety profile in newly diagnosed pediatric AML, with early evidence of clinical activity in this population.<\/jats:p>\n                    <jats:p>\n                      <jats:bold>Clinical Trial Registration<\/jats:bold>\n                      : Chinese Clinical Trial Registry: ChiCTR2300067964 (\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"https:\/\/www.chictr.org.cn\/showproj.html?proj=188738\">https:\/\/www.chictr.org.cn\/showproj.html?proj=188738<\/jats:ext-link>\n                      ).\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/1545-5017.70359","type":"journal-article","created":{"date-parts":[[2026,5,18]],"date-time":"2026-05-18T07:56:32Z","timestamp":1779090992000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Pharmacokinetics, Efficacy, and Safety Profiles of Mitoxantrone Hydrochloride Liposome Plus Cytarabine in Pediatric Patients With Newly Diagnosed Acute Myeloid Leukemia"],"prefix":"10.1002","volume":"73","author":[{"given":"Wenyu","family":"Yang","sequence":"first","affiliation":[{"name":"State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem Institute of Hematology &amp; 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Blood Diseases Hospital, Chinese Academy of Medical Sciences &amp; Peking Union Medical College  Tianjin China"},{"name":"Tianjin Institutes of Health Science  Tianjin China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9048-5720","authenticated-orcid":false,"given":"Lipeng","family":"Liu","sequence":"additional","affiliation":[{"name":"State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem Institute of Hematology &amp; Blood Diseases Hospital, Chinese Academy of Medical Sciences &amp; Peking Union Medical College  Tianjin China"},{"name":"Tianjin Institutes of Health Science  Tianjin China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8381-0065","authenticated-orcid":false,"given":"Aoli","family":"Zhang","sequence":"additional","affiliation":[{"name":"State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem Institute of Hematology &amp; 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