Evidence map›Paper›PMID 26691423›Full record

Trial reportBone marrow transplantation2016

Higher tacrolimus concentrations early after transplant reduce the risk of acute GvHD in reduced-intensity allogeneic stem cell transplantation.

A Ganetsky, A Shah, T A Miano, W-T Hwang, J He, A W Loren, E O Hexner, N V Frey, D L Porter, R Reshef

Registry-linked trialOpen access · bronzeAbstract readClinical Trial
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 NCT04645667 (Development of a Population Pharmacokinetic Model to Optimize Tacrolimus Dosing in Adult Recipients of Allogeneic Hematopoietic Stem Cell Transplant.), which is not on this map. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed
1.9field-weighted citation impact, top 14% 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.

NCT04645667 completednot on this mapstarted 2021, after this paper: background citation

Development of a Population Pharmacokinetic Model to Optimize Tacrolimus Dosing in Adult Recipients of Allogeneic Hematopoietic Stem Cell Transplant.

TypeobservationalSponsorUNC Lineberger Comprehensive Cancer CenterRan2021 to 2023Enrolled38ConditionsAcute GVHDArmsTacrolimus
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 49 citations in OpenAlex.

  1. Trial
  2. Extended CCR5 Blockade for Graft-versus-Host Disease Prophylaxis Improves Outcomes of Reduced-Intensity Unrelated Donor Hematopoietic Cell Transplantation: A Phase II Clinical Trial.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2019
    Trial
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  8. Effects ofPharmaceuticals (Basel, Switzerland) · 2024
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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

10 authors at 3 institutions in 1 country.

A GanetskyDepartment of Pharmacy, Hospital of the University of Pennsylvania, Philadelphia, PA, USA.
A ShahDepartment of Pharmacy, Hospital of the University of Pennsylvania, Philadelphia, PA, USA.
T A MianoCenter for Pharmacoepidemiology Research and Training, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
W-T HwangDepartment of Biostatistics and Epidemiology, Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
J HeDepartment of Biostatistics and Epidemiology, Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
A W LorenBlood and Marrow Transplantation Program, Abramson Cancer Center and the Division of Hematology and Oncology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
E O HexnerBlood and Marrow Transplantation Program, Abramson Cancer Center and the Division of Hematology and Oncology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
N V FreyBlood and Marrow Transplantation Program, Abramson Cancer Center and the Division of Hematology and Oncology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
D L PorterBlood and Marrow Transplantation Program, Abramson Cancer Center and the Division of Hematology and Oncology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
R ReshefBlood and Marrow Transplantation Program and Columbia Center for Translational Immunology, Department of Medicine, Columbia University Medical Center, New York, NY, USA.ORCID http://orcid.org/0000-0003-2185-9546
University of Pennsylvania · USHospital of the University of Pennsylvania · USColumbia University Irving Medical Center · US

Funding

Bone Marrow Transplant Clinical NetworkU01HL069286 · NHLBI · UNIVERSITY OF PENNSYLVANIA · PI STADTMAUER, EDWARD A · 2001 to 2010
$2.1M
Lymphocyte trafficking blockade in allogeneic stem-cell transplantationK23CA178202 · NCI · UNIVERSITY OF PENNSYLVANIA · PI RESHEF, RAN · 2013 to 2015
$520k
NCI NIH HHS K23 CA178202NCI NIH HHS K23-CA178202NHLBI NIH HHS U01 HL069286NHLBI NIH HHS U01-HL069286
6 · The paper itself

Abstract

There is significant variability in the serum concentrations of tacrolimus attained early post transplant due to drug interactions and genomic variation. We evaluated whether tacrolimus concentrations early post transplant correlated with incidence of acute GvHD in 120 consecutive patients allografted with a uniform reduced-intensity conditioning regimen. All patients received standard prophylaxis with oral tacrolimus and IV methotrexate. The primary variable of interest was mean weekly tacrolimus concentrations in the initial 4 weeks post transplant. In multivariate analysis, week 1 tacrolimus concentration was an independent predictor of acute grade 2-4 GvHD (hazard ratio (HR), 0.90; 95% confidence interval (CI), 0.84-0.97; P<0.01). This association was driven by a lower risk of acute grade 2-4 GvHD in patients with week 1 tacrolimus concentrations >12 ng/mL (HR, 0.47; 95% CI, 0.25-0.88; P=0.02). Week 1 tacrolimus concentrations were not associated with chronic GvHD, relapse or overall survival. Lower tacrolimus concentrations at weeks 2, 3 and 4 were not associated with a higher incidence of GvHD. In summary, we found that higher tacrolimus concentrations during the first week after allografting with a reduced-intensity conditioning regimen were associated with significantly reduced risk of acute grade 2-4 GvHD without increasing risk of relapse.

Indexed as

Graft vs Host DiseaseHematologic DiseasesStem Cell TransplantationTacrolimusTransplantation ConditioningAcute DiseaseAdministration, OralAdultAgedAllograftsFemaleHumansMaleMethotrexateMiddle AgedTime FactorsMethotrexateTacrolimus

Identifiers

PMID26691423
PMCPMC5775750
OpenAlexW2234054426

What OpenQuestion holds

Textmetadata
LicenceTDM
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.