{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,8]],"date-time":"2026-02-08T14:10:21Z","timestamp":1770559821149,"version":"3.49.0"},"reference-count":52,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2018,3,2]],"date-time":"2018-03-02T00:00:00Z","timestamp":1519948800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["American J Hematol"],"published-print":{"date-parts":[[2018,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>The aim of this prospective clinical trial was to evaluate the efficacy and safety of a combination of Gemtuzumab\u2010Ozogamicin (GO) and FLAI scheme (fludarabine, cytarabine, idarubicin) as a first\u2010line therapy in CD33 positive AML. We treated 130 patients, aged &lt;65, with a median age of 52 years. FLAI\u2010GO induction regimen included fludarabine (30 mg\/sqm) and cytarabine (2 g\/sqm) on days 1\u20135; idarubicin (10 mg\/sqm) on days 1, 3, and 5; and GO (3 mg\/sqm) on day 6. SCT was planned for all high\u2010risk AML patients, after consolidation with intermediate doses of cytarabine and idarubicin and a high dose of cytarabine. CD33 expression exceeded 20% in all cases. Primary endpoints of the study included feasibility, overall response rate (ORR) and toxicity. Secondary endpoints included the evaluation of MRD by WT1 expression, feasibility and outcome of consolidation with SCT, overall survival (OS) and disease\u2010free survival (DFS).<\/jats:p><jats:p>After induction with FLAI\u2010GO, complete remission (CR) rate was 82%. Four patients achieved partial remission (PR) and 12% were resistant (ORR 85%); death during induction (DDI) was 3%. The hematological and extra hematological toxicity of FLAI\u2010GO was manageable; 45% of patients experienced transient and reversible GO infusion related adverse events. In the setting of patients who achieved a cytological CR after FLAI\u2010GO, the mean of WT1 copies dropped from 8337\u00b19936 copies\/10<jats:sup>4<\/jats:sup>ABL (diagnosis) to 182\u2009\u00b1\u2009436 copies after induction therapy (<jats:italic>p<\/jats:italic>\u2009=\u20090.0001) showing a very good disease debulking. After a median follow\u2010up of 54 months, 67\/130 (52%) patients were alive. The probability of 1, 2, and 5\u2010year OS was 80%, 63%, and 52%, respectively. The probability of 1, 2, and 5\u2010year DFS was 77%, 58%, and 52%, respectively. Allogeneic and autologous SCT was performed in 60 (46%) and 23 (18%) patients, respectively.<\/jats:p><jats:p>In summary, the final results of this trial confirm that FLAI\u2010GO is an active and safe treatment strategy for CD33\u2010positive AML patients aged \u2264 65 years, allowing a high ORR, a good disease debulking, favorable safety profile, low DDI, and subsequent high SCT rate. The encouraging results of this trial, consolidated by a long follow\u2010up, support the reintroduction of GO in clinical practice.<\/jats:p>","DOI":"10.1002\/ajh.25057","type":"journal-article","created":{"date-parts":[[2018,2,3]],"date-time":"2018-02-03T01:46:34Z","timestamp":1517622394000},"page":"655-663","source":"Crossref","is-referenced-by-count":32,"title":["Flai (fludarabine, cytarabine, idarubicin) plus low\u2010dose Gemtuzumab Ozogamicin as induction therapy in CD33\u2010positive AML: Final results and long term outcome of a phase II multicenter clinical trial"],"prefix":"10.1002","volume":"93","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9665-0435","authenticated-orcid":false,"given":"Anna","family":"Candoni","sequence":"first","affiliation":[{"name":"Division of Hematology and SCT University of Udine Udine Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cristina","family":"Papayannidis","sequence":"additional","affiliation":[{"name":"Institute of Hematology and Oncology L. and A. Ser\u00e0gnoli, University of Bologna Bologna Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Giovanni","family":"Martinelli","sequence":"additional","affiliation":[{"name":"Institute of Hematology and Oncology L. and A. Ser\u00e0gnoli, University of Bologna Bologna Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Erica","family":"Simeone","sequence":"additional","affiliation":[{"name":"Division of Hematology and SCT University of Udine Udine Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michele","family":"Gottardi","sequence":"additional","affiliation":[{"name":"Division of Hematology Hospital of Treviso Treviso Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ilaria","family":"Iacobucci","sequence":"additional","affiliation":[{"name":"Institute of Hematology and Oncology L. and A. 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