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Phase IV open-label study of the efficacy and safety of deferasirox after allogeneic stem cell transplantation

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Phase IV open-label study of the efficacy and safety of deferasirox after allogeneic stem cell transplantation

dc.contributor.author	Vallejo, Carlos	es_ES
dc.contributor.author	Batlle, Montserrat	es_ES
dc.contributor.author	Vázquez, Lourdes	es_ES
dc.contributor.author	Solano Vercet, Carlos	es_ES
dc.contributor.author	Sampol Mayol, Antonia	es_ES
dc.contributor.author	Duarte, Rafael	es_ES
dc.contributor.author	Hernández, Dolores	es_ES
dc.contributor.author	López, Javier	es_ES
dc.contributor.author	Rovira, Montserrat	es_ES
dc.contributor.author	Jiménez, Santiago	es_ES
dc.contributor.author	Valcárcel, David	es_ES
dc.contributor.author	Belloch, Vicente	es_ES
dc.contributor.author	Jiménez, Mónica	es_ES
dc.contributor.author	Jarque, Isidro	es_ES
dc.date.accessioned	2015-06-18T07:05:52Z
dc.date.available	2015-06-18T07:05:52Z
dc.date.issued	2014	es_ES
dc.identifier.citation	Haematologica Vol. 99 Issue 10: pp. 1632-1637	es_ES
dc.identifier.uri	http://hdl.handle.net/10550/44435
dc.description.abstract	This is the first prospective study of deferasirox in adult allogeneic hematopoietic stem cell transplant recipients with transfusional iron overload in hematologic malignancies. Patients at least six months post transplant were treated with deferasirox at a starting dose of 10 mg/kg/day for 52 weeks or until serum ferritin was less than 400 ng/mL on two consecutive occasions. Thirty patients were enrolled and 22 completed the study. A significant reduction from baseline in median serum ferritin and in liver iron concentration at 52 weeks was observed in the overall population: from 1440 to 755.5 ng/mL (P=0.002) and from 14.5 to 4.6 mg Fe/g dw (P=0.0007), respectively. Reduction in serum ferritin in patients who did not discontinue deferasirox therapy was significantly greater than that found in those who prematurely discontinued the treatment (from 1541 to 581 ng/mL vs. from 1416 to 1486 ng/mL; P=0.008). Drug-related adverse events, reported in 17 patients (56.7%), were mostly mild to moderate in severity. There were no drug-related serious adverse events. Twelve patients (40.0%) showed an increase of over 33% in serum creatinine compared to baseline and greater than the upper limit of normal on two consecutive visits. Two patients (6.7%) with active graft-versus-host disease showed an increase in alanine aminotransferase exceeding 10 times upper limit of normal; both resolved. In this prospective study, deferasirox provided a significant reduction in serum ferritin and liver iron concentration over one year of treatment in allogeneic hematopoietic stem cell transplant recipients with iron overload. In addition, the majority of adverse events related to deferasirox were mild or moderate in severity. (clinicaltrials.gov identifier:01335035).	es_ES
dc.title	Phase IV open-label study of the efficacy and safety of deferasirox after allogeneic stem cell transplantation	es_ES
dc.type	journal article	es_ES
dc.identifier.doi	10.3324/haematol.2014.105908	es_ES
dc.identifier.idgrec	103235	es_ES