{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T04:08:53Z","timestamp":1791950933222,"version":"4.3.4"},"reference-count":40,"publisher":"American Society of Hematology","issue":"3","content-domain":{"domain":["ashpublications.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2026,1,15]]},"abstract":"<jats:sec>\n                    <jats:title>Abstract<\/jats:title>\n                    <jats:p>Myeloid leukemia of Down syndrome (ML-DS) is associated with an excellent prognosis but high treatment-related toxicity and mortality. The Phase 3 Clinical Trial for CPX-351 in ML-DS 2018 aimed to maintain the excellent event-free survival (EFS) achieved in the previous ML-DS 2006 trial while reducing the treatment intensity. Intensity-reduced induction and reinduction therapy with cytarabine and idarubicin with or without etoposide was replaced with CPX-351 (66 U\/m2 on 3 days in course 1 and on 2 days in course 2). Risk stratification was based on flow cytometric measurable residual disease (MRD) after first induction. High-risk patients received high-dose cytarabine (3 g\/m2 per 12 hour) in consolidation; standard-risk patients received cytarabine at a dose of 1 g\/m2 per 12 hour. A total of 35 patients were enrolled until the trial was halted because of an unexpectedly high relapse rate. A per-protocol interim analysis revealed a significantly lower 24-month EFS when compared with the ML-DS 2006 trial (69% vs 90%; P&amp;lt; .001). In contrast with previous studies, most patients who relapsed responded to salvage therapy, leading to a comparable 24-month overall survival of 88% (vs 92%; P = .612). CPX-351 demonstrated a favorable toxicity profile with no treatment-related mortality. Positive MRD by error-corrected GATA1 next-generation sequencing, the presence of trisomy 8 or a complex karyotype were associated with an increased risk for relapse. In conclusion, replacing intensity-reduced induction therapy with CPX-351 in ML-DS led to a significantly lower EFS, highlighting the need for dose optimization to balance the efficacy and toxicity in this sensitive patient population. This trial was registered at https:\/\/www.clinicaltrialsregister.eu as EudraCT #2018-002988-25.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1182\/blood.2025030775","type":"journal-article","created":{"date-parts":[[2025,10,21]],"date-time":"2025-10-21T19:48:55Z","timestamp":1761076135000},"page":"229-240","update-policy":"https:\/\/doi.org\/10.1182\/blood.2019cm0000","source":"Crossref","is-referenced-by-count":11,"title":["CPX-351 in Down syndrome\u2013associated myeloid leukemia: results and prognostic factors from the phase 3 ML-DS 2018 trial"],"prefix":"10.1182","volume":"147","author":[{"given":"Stephanie","family":"Laszig","sequence":"first","affiliation":[{"name":"1Department of Pediatrics, Goethe-University Frankfurt, Frankfurt, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonia","family":"Diederichs","sequence":"additional","affiliation":[{"name":"1Department of Pediatrics, Goethe-University Frankfurt, Frankfurt, 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