Evidence map›Paper›PMID 26367238›Full record

Trial reportBone marrow transplantation2016

Efficacy and safety of deferasirox in non-thalassemic patients with elevated ferritin levels after allogeneic hematopoietic stem cell transplantation.

N Jaekel, K Lieder, S Albrecht, O Leismann, K Hubert, G Bug, N Kröger, U Platzbecker, M Stadler, K de Haas and 4 more

Registry-linked trialAbstract readClinical TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Bone marrow transplantation, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00654589 (A One-year, Open-label, Single Arm, Multi-center Trial Evaluating the Efficacy and Safety of Oral ICL670), which is not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
2.1field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00654589 phase4completednot on this map

A One-year, Open-label, Single Arm, Multi-center Trial Evaluating the Efficacy and Safety of Oral ICL670 (20 mg/kg/d) in Patients Three to Six Months After Allogeneic Hematopoietic Cell Transplantation in Whom Iron Overload is Present

TypeinterventionalSponsorNovartis PharmaceuticalsRan2008 to 2012Enrolled75ConditionsIron OverloadArmsDeferasirox
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 34 citations in OpenAlex.

  1. [Guidelines for iron chelation therapy in thalassemia in China (2025)].Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics · 2025
    Guideline
  2. Trial
  3. Review
  4. Review
  5. Review
  6. Review
  7. Article
  8. Article
  9. Iron Toxicity and Hemopoietic Cell Transplantation: Time to Change the Paradigm.Mediterranean journal of hematology and infectious diseases · 2019
    Review
  10. Article
  11. Article
  12. Article
  13. Current Review of Iron Overload and Related Complications in Hematopoietic Stem Cell Transplantation.Turkish journal of haematology : official journal of Turkish Society of Haematology · 2017
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 7 institutions in 1 country.

N JaekelDepartment of Hematology/Oncology, University Hospital of Leipzig, Leipzig, Germany.
K LiederNovartis Pharma GmbH, Nürnberg, Germany.
S AlbrechtNovartis Pharma GmbH, Nürnberg, Germany.
O LeismannNovartis Pharma GmbH, Nürnberg, Germany.
K HubertDepartment of Hematology/Oncology, University Hospital of Leipzig, Leipzig, Germany.
G BugMedizinische Klinik II, University Hospital Frankfurt, Frankfurt am Main, Germany.
N KrögerUniversity Hospital Hamburg, Hamburg, Germany.
U PlatzbeckerUniversity of Dresden, Dresden, Germany.
M StadlerDepartment of Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.
K de HaasUniversity of Kiel, Kiel, Germany.
S AltamuraMolecular Medicine Partnership Unit and Department of Pediatric Oncology, Hematology and Immunology, University Clinic of Heidelberg, Heidelberg, Germany.
M U MuckenthalerMolecular Medicine Partnership Unit and Department of Pediatric Oncology, Hematology and Immunology, University Clinic of Heidelberg, Heidelberg, Germany.
D NiederwieserDepartment of Hematology/Oncology, University Hospital of Leipzig, Leipzig, Germany.
H K Al-AliDepartment of Hematology/Oncology, University Hospital of Leipzig, Leipzig, Germany.
University Hospital Leipzig · DENovartis (Germany) · DEHeidelberg University · DEGoethe University Frankfurt · DEKiel University · DEMedizinische Hochschule Hannover · DEUniversität Hamburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

Hematopoietic Stem Cell TransplantationIron Metabolism DisordersAdultAgedAllograftsBenzoatesCyclosporineDeferasiroxFemaleFerritinsHumansIronMaleMiddle AgedProspective StudiesTriazolesBenzoatesCyclosporineDeferasiroxFerritinsIronTriazoles

Identifiers

PMID26367238
OpenAlexW2226523083

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.