PMID- 26367238
OWN - NLM
STAT- MEDLINE
DCOM- 20160929
LR  - 20181202
IS  - 1476-5365 (Electronic)
IS  - 0268-3369 (Linking)
VI  - 51
IP  - 1
DP  - 2016 Jan
TI  - Efficacy and safety of deferasirox in non-thalassemic patients with elevated 
      ferritin levels after allogeneic hematopoietic stem cell transplantation.
PG  - 89-95
LID - 10.1038/bmt.2015.204 [doi]
AB  - Elevated serum ferritin contributes to treatment-related morbidity and mortality 
      after allogeneic hematopoietic stem cell transplantation (HSCT). The multicenter 
      DE02 trial assessed the safety, efficacy and impact of deferasirox on iron 
      homeostasis after allogeneic HSCT. Deferasirox was administered at a starting 
      dose of 10 mg/kg per day to 76 recipients of allogeneic HSCT, with subsequent 
      dose adjustments based on efficacy and safety. Deferasirox was initiated at a 
      median of 168 days after HSCT, with 84% of patients still on immunosuppression. 
      Baseline serum ferritin declined from 2045 to 957 ng/mL. Deferasirox induced a 
      negative iron balance in 84% of patients. Hemoglobin increased in the first 3 
      months, and trough serum cyclosporine levels were stable. Median exposure was 330 
      days, with a median compliance rate of >80%. The most common 
      investigator-reported drug-related adverse events (AEs) were increased blood 
      creatinine (26.5%), nausea (9.0%) and abdominal discomfort (8.3%). Fifty-four 
      (71.1%) patients experienced drug-related AEs, which occasionally resulted in 
      discontinuation (gastrointestinal (n=6), skin (n=3), elevated transaminases (n=1) 
      and creatinine (n=1)). The incidence of AEs appeared to be dose related, with 
      7.5 mg/kg per day being the best-tolerated dose. Low-dose deferasirox is an 
      effective chelation therapy after allogeneic HSCT, with a manageable safety 
      profile, even in patients receiving cyclosporine.
FAU - Jaekel, N
AU  - Jaekel N
AD  - Department of Hematology/Oncology, University Hospital of Leipzig, Leipzig, 
      Germany.
FAU - Lieder, K
AU  - Lieder K
AD  - Novartis Pharma GmbH, Nurnberg, Germany.
FAU - Albrecht, S
AU  - Albrecht S
AD  - Novartis Pharma GmbH, Nurnberg, Germany.
FAU - Leismann, O
AU  - Leismann O
AD  - Novartis Pharma GmbH, Nurnberg, Germany.
FAU - Hubert, K
AU  - Hubert K
AD  - Department of Hematology/Oncology, University Hospital of Leipzig, Leipzig, 
      Germany.
FAU - Bug, G
AU  - Bug G
AD  - Medizinische Klinik II, University Hospital Frankfurt, Frankfurt am Main, 
      Germany.
FAU - Kroger, N
AU  - Kroger N
AD  - University Hospital Hamburg, Hamburg, Germany.
FAU - Platzbecker, U
AU  - Platzbecker U
AD  - University of Dresden, Dresden, Germany.
FAU - Stadler, M
AU  - Stadler M
AD  - Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation, 
      Hannover Medical School, Hannover, Germany.
FAU - de Haas, K
AU  - de Haas K
AD  - University of Kiel, Kiel, Germany.
FAU - Altamura, S
AU  - Altamura S
AD  - Molecular Medicine Partnership Unit and Department of Pediatric Oncology, 
      Hematology and Immunology, University Clinic of Heidelberg, Heidelberg, Germany.
FAU - Muckenthaler, M U
AU  - Muckenthaler MU
AD  - Molecular Medicine Partnership Unit and Department of Pediatric Oncology, 
      Hematology and Immunology, University Clinic of Heidelberg, Heidelberg, Germany.
FAU - Niederwieser, D
AU  - Niederwieser D
AD  - Department of Hematology/Oncology, University Hospital of Leipzig, Leipzig, 
      Germany.
FAU - Al-Ali, H K
AU  - Al-Ali HK
AD  - Department of Hematology/Oncology, University Hospital of Leipzig, Leipzig, 
      Germany.
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20150914
PL  - England
TA  - Bone Marrow Transplant
JT  - Bone marrow transplantation
JID - 8702459
RN  - 0 (Benzoates)
RN  - 0 (Triazoles)
RN  - 83HN0GTJ6D (Cyclosporine)
RN  - 9007-73-2 (Ferritins)
RN  - E1UOL152H7 (Iron)
RN  - V8G4MOF2V9 (Deferasirox)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Allografts
MH  - Benzoates/*administration & dosage/adverse effects/*pharmacokinetics
MH  - Cyclosporine/administration & dosage/adverse effects/blood
MH  - Deferasirox
MH  - Female
MH  - Ferritins/*blood
MH  - *Hematopoietic Stem Cell Transplantation
MH  - Humans
MH  - Iron/*blood
MH  - *Iron Metabolism Disorders/blood/drug therapy/etiology
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Triazoles/*administration & dosage/adverse effects/*pharmacokinetics
EDAT- 2015/09/15 06:00
MHDA- 2016/09/30 06:00
CRDT- 2015/09/15 06:00
PHST- 2015/04/02 00:00 [received]
PHST- 2015/07/18 00:00 [revised]
PHST- 2015/07/23 00:00 [accepted]
PHST- 2015/09/15 06:00 [entrez]
PHST- 2015/09/15 06:00 [pubmed]
PHST- 2016/09/30 06:00 [medline]
AID - bmt2015204 [pii]
AID - 10.1038/bmt.2015.204 [doi]
PST - ppublish
SO  - Bone Marrow Transplant. 2016 Jan;51(1):89-95. doi: 10.1038/bmt.2015.204. Epub 
      2015 Sep 14.