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• W1985439142 abstract "Myeloablative allogeneic stem cell transplant (MA AlloSCT) for childhood AML may be associated with significant acute toxicity, late effects and/or recurrent disease (Woods et al; Blood, 2001). Reduced intensity (RI) AlloSCT may offer less acute toxicity and/or reduced late effects for children with cancer (Del Toro/Cairo et al; BMT, 2004, Satwani/Cairo, BBMT, 2005). Gemtuzumab ozogamicin (GO) has induced responses in >30% of patients with recurrent CD33+ AML (Sievers et al; J Clin Oncol, 2001). We explored the feasibility and toxicity of RI AlloSCT followed by GO targeted immunotherapy as consolidation in children with CD33+ AML. Eleven patients, 11 years (0.5-21) with CD33+ AML, 8-CR1 and 3-CR2 (M0-1, M1-1, M3-1, M4-3, M4/5-1 and M5-4) received fludarabine 30mg/m2x6d and busulfan 3.2-4mg/kgx2d ± rabbit ATG 2mg/kgx4d. Donors: 7 6/6 HLA related peripheral blood stem cells (RPBSC), 1 5/6 RPBSC, 1 6/6 related cord blood (CB) and 2 4/6 unrelated CB. GOx2 was administered ≥60d post AlloSCTx2 (8wks apart), following a dose escalation design (4.5, 6 and 7.5mg/m2). Median neutrophil and platelet engraftment after RI AlloSCT for 10/11 evaluable patients was on d15±4 and d16±16, respectively. One primary graft failure relapsed after a MA AlloSCT. Donor chimerism in 10/11 evaluable patients was 97±2% (d30) and 95±11% (d365). Eight patients received two doses of GO (4.5mg/m2 [n=3], 6mg/m2[n=4], 7.5mg/m2 [n=1]); one patient received one dose of GO and relapsed and died of AML. One patient has not yet reached d60. The median time between AlloSCT and 1st and 2nd doses of GO was 70 and 150 d, respectively. All patients experienced grade 4 neutropenia following each GO course with recovery (ANC>500/mm3x2d) on median d18 and 14, respectively. Grade 4 thrombocytopenia was only observed in 6/17 GO courses, with recovery (platelets>20,000/mm3, without transfusion) following each GO course on median d4 and 0, respectively. Eight patients are alive with no evidence of disease (NED); the ninth, with NED expired from cGVHD. Estimated 1-yr OS for CR1 and CR2 is 67.5%. No patients have developed dose-limiting toxicity secondary to GO. RI AlloSCT in average risk AML results in >95% donor chimerism and administration of GO post RI AlloSCT is well tolerated. The maximal tolerated dose has yet to be determined for GO post RI AlloSCT in children with CD33+ AML." @default.
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• W1985439142 date "2007-02-01" @default.
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• W1985439142 title "76: Reduced intenity allogeneic stem cell transplantion followed by targeted consolidation immunotherapy with gemtuzumab ozogamicin in children and adolescents with CD33+ acute myeloid leukemia" @default.
• W1985439142 doi "https://doi.org/10.1016/j.bbmt.2006.12.079" @default.
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