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000128816 0247_ $$2doi$$a10.3324/haematol.2015.141622
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000128816 0247_ $$2ISSN$$a1592-8721
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000128816 037__ $$aDKFZ-2017-04829
000128816 041__ $$aeng
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000128816 1001_ $$aHütter-Krönke, Marie-Luise$$b0
000128816 245__ $$aSalvage therapy with high-dose cytarabine and mitoxantrone in combination with all-trans retinoic acid and gemtuzumab ozogamicin in acute myeloid leukemia refractory to first induction therapy.
000128816 260__ $$aPavia$$bFerrata Storti Foundation$$c2016
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000128816 520__ $$aOutcome of patients with primary refractory acute myeloid leukemia remains unsatisfactory. We conducted a prospective phase II clinical trial with gemtuzumab ozogamicin (3 mg/m(2) intravenously on day 1), all-trans retinoic acid (45 mg/m(2) orally on days 4-6 and 15 mg/m(2) orally on days 7-28), high-dose cytarabine (3 g/m(2)/12 h intravenously on days 1-3) and mitoxantrone (12 mg/m(2) intravenously on days 2-3) in 93 patients aged 18-60 years refractory to one cycle of induction therapy. Primary end point of the study was response to therapy; secondary end points included evaluation of toxicities, in particular, rate of sinusoidal obstruction syndrome after allogeneic hematopoietic cell transplantation. Complete remission or complete remission with incomplete blood count recovery was achieved in 47 (51%) and partial remission in 10 (11%) patients resulting in an overall response rate of 61.5%; 33 (35.5%) patients had refractory disease and 3 patients (3%) died. Allogeneic hematopoietic cell transplantation was performed in 71 (76%) patients; 6 of the 71 (8.5%) patients developed moderate or severe sinusoidal obstruction syndrome after transplantation. Four-year overall survival rate was 32% (95% confidence interval 24%-43%). Patients responding to salvage therapy and undergoing allogeneic hematopoietic cell transplantation (n=51) had a 4-year survival rate of 49% (95% confidence intervaI 37%-64%). Patients with fms-like tyrosine kinase internal tandem duplication positive acute myeloid leukemia had a poor outcome despite transplantation. In conclusion, the described regimen is an effective and tolerable salvage therapy for patients who are primary refractory to one cycle of conventional intensive induction therapy. (clinicaltrials.gov identifier: 00143975).
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000128816 650_7 $$2NLM Chemicals$$aAminoglycosides
000128816 650_7 $$2NLM Chemicals$$aAntibodies, Monoclonal, Humanized
000128816 650_7 $$004079A1RDZ$$2NLM Chemicals$$aCytarabine
000128816 650_7 $$05688UTC01R$$2NLM Chemicals$$aTretinoin
000128816 650_7 $$093NS566KF7$$2NLM Chemicals$$agemtuzumab
000128816 650_7 $$0BZ114NVM5P$$2NLM Chemicals$$aMitoxantrone
000128816 7001_ $$0P:(DE-He78)e15dfa1260625c69d6690a197392a994$$aBenner, Axel$$b1$$udkfz
000128816 7001_ $$aDöhner, Konstanze$$b2
000128816 7001_ $$aKrauter, Jürgen$$b3
000128816 7001_ $$aWeber, Daniela$$b4
000128816 7001_ $$aMoessner, Margit$$b5
000128816 7001_ $$aKöhne, Claus-Henning$$b6
000128816 7001_ $$aHorst, Heinz A$$b7
000128816 7001_ $$aSchmidt-Wolf, Ingo G H$$b8
000128816 7001_ $$aRummel, Mathias$$b9
000128816 7001_ $$aGötze, Katharina$$b10
000128816 7001_ $$aKoller, Elisabeth$$b11
000128816 7001_ $$aPetzer, Andreas L$$b12
000128816 7001_ $$aSalwender, Hans$$b13
000128816 7001_ $$aFiedler, Walter$$b14
000128816 7001_ $$aKirchen, Heinz$$b15
000128816 7001_ $$aHaase, Detlef$$b16
000128816 7001_ $$aKremers, Stephan$$b17
000128816 7001_ $$aTheobald, Matthias$$b18
000128816 7001_ $$aMatzdorff, Axel C$$b19
000128816 7001_ $$aGanser, Arnold$$b20
000128816 7001_ $$aDöhner, Hartmut$$b21
000128816 7001_ $$aSchlenk, Richard F$$b22
000128816 773__ $$0PERI:(DE-600)2805244-4$$a10.3324/haematol.2015.141622$$gVol. 101, no. 7, p. 839 - 845$$n7$$p839 - 845$$tHaematologica$$v101$$x1592-8721$$y2016
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000128816 9141_ $$y2016
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