Evidence map›Paper›PMID 25840599›Full record

Trial reportHaematologica2015

Prolonged sirolimus administration after allogeneic hematopoietic cell transplantation is associated with decreased risk for moderate-severe chronic graft-versus-host disease.

Joseph Pidala, Jongphil Kim, Melissa Alsina, Ernesto Ayala, Brian C Betts, Hugo F Fernandez, Teresa Field, Heather Jim, Mohamed A Kharfan-Dabaja, Frederick L Locke and 6 more

Open access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Haematologica, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
1.7field-weighted citation impact, top 16% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Chronic GVHD: review advances in prevention, novel endpoints, and targeted strategies.Hematology. American Society of Hematology. Education Program · 2023
    Article
  6. Article
  7. Review
  8. Article
  9. Observational
  10. Article
  11. Article
  12. Article
  13. Review
  14. [Progress of chronic graft-versus-host disease].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2016
    Article
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

16 authors at 2 institutions in 1 country.

Joseph PidalaBlood and Marrow Transplantation, Moffitt Cancer Center, USA Oncologic Sciences, College of Medicine at University of South Florida, USA joseph.pidala@moffitt.org.
Jongphil KimOncologic Sciences, College of Medicine at University of South Florida, USA Biostatistics, Moffitt Cancer Center; USA.
Melissa AlsinaBlood and Marrow Transplantation, Moffitt Cancer Center, USA Oncologic Sciences, College of Medicine at University of South Florida, USA.
Ernesto AyalaBlood and Marrow Transplantation, Moffitt Cancer Center, USA Oncologic Sciences, College of Medicine at University of South Florida, USA.
Brian C BettsBlood and Marrow Transplantation, Moffitt Cancer Center, USA Oncologic Sciences, College of Medicine at University of South Florida, USA.
Hugo F FernandezBlood and Marrow Transplantation, Moffitt Cancer Center, USA Oncologic Sciences, College of Medicine at University of South Florida, USA.
Teresa FieldBlood and Marrow Transplantation, Moffitt Cancer Center, USA Oncologic Sciences, College of Medicine at University of South Florida, USA.
Heather JimOncologic Sciences, College of Medicine at University of South Florida, USA Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, Fl, USA.
Mohamed A Kharfan-DabajaBlood and Marrow Transplantation, Moffitt Cancer Center, USA Oncologic Sciences, College of Medicine at University of South Florida, USA.
Frederick L LockeBlood and Marrow Transplantation, Moffitt Cancer Center, USA Oncologic Sciences, College of Medicine at University of South Florida, USA.
Asmita MishraBlood and Marrow Transplantation, Moffitt Cancer Center, USA Oncologic Sciences, College of Medicine at University of South Florida, USA.
Taiga NishihoriBlood and Marrow Transplantation, Moffitt Cancer Center, USA Oncologic Sciences, College of Medicine at University of South Florida, USA.
Leonel Ochoa-BayonaBlood and Marrow Transplantation, Moffitt Cancer Center, USA Oncologic Sciences, College of Medicine at University of South Florida, USA.
Lia PerezBlood and Marrow Transplantation, Moffitt Cancer Center, USA Oncologic Sciences, College of Medicine at University of South Florida, USA.
Marcie RichesBlood and Marrow Transplantation, Moffitt Cancer Center, USA Oncologic Sciences, College of Medicine at University of South Florida, USA.
Claudio AnasettiBlood and Marrow Transplantation, Moffitt Cancer Center, USA Oncologic Sciences, College of Medicine at University of South Florida, USA.
Moffitt Cancer Center · USUniversity of South Florida · US

Funding

TRANSLATIONAL RESEARCHP30CA076292 · NCI · UNIVERSITY OF SOUTH FLORIDA · PI KENNETH Lynn WRIGHT · 1998 to 2026
$93.5M
Antigen Specific T Cell tolerance by Anti CD3 AntibodiesR01CA132197 · NCI · H. LEE MOFFITT CANCER CTR & RES INST · PI ANASETTI, CLAUDIO · 2008 to 2012
$1.8M
NCI NIH HHS 9R01CA132197NCI NIH HHS P30 CA076292NCI NIH HHS P30-CA076292NCI NIH HHS R01 CA132197
6 · The paper itself

Abstract

Effective pharmacological strategies employed in allogeneic hematopoietic cell transplantation should prevent serious chronic graft-versus-host disease and facilitate donor-recipient immune tolerance. Based on demonstrated pro-tolerogenic activity, sirolimus (rapamycin) is an agent with promise to achieve these goals. In a long-term follow-up analysis of a randomized phase II trial comparing sirolimus/tacrolimus versus methotrexate/tacrolimus for graft-versus-host disease prevention in matched sibling or unrelated donor transplant, we examined the impact of prolonged sirolimus administration (≥ 1 year post-transplant). Median follow-up time for surviving patients at time of this analysis was 41 months (range 27-60) for sirolimus/tacrolimus and 49 months (range 29-63) for methotrexate/tacrolimus. Sirolimus/tacrolimus patients had significantly lower National Institutes of Health Consensus moderate-severe chronic graft-versus-host disease (34% vs. 65%; P=0.004) and late acute graft-versus-host disease (20% vs. 43%; P=0.04). While sirolimus/tacrolimus patients had lower prednisone exposure and earlier discontinuation of tacrolimus (median time to tacrolimus discontinuation 368 days vs. 821 days; P=0.002), there was no significant difference in complete immune suppression discontinuation (60-month estimate: 43% vs. 31%; P=0.78). Prolonged sirolimus administration represents a viable approach to mitigate risk for moderate-severe chronic and late acute graft-versus-host disease. Further study of determinants of successful immune suppression discontinuation is needed.

Indexed as

Hematopoietic Stem Cell TransplantationAcute DiseaseAntimetabolites, AntineoplasticChronic DiseaseGraft vs Host DiseaseHematologic NeoplasmsHumansImmunosuppressive AgentsMethotrexateSeverity of Illness IndexSiblingsSirolimusSurvival AnalysisTacrolimusTransplantation ConditioningTransplantation, HomologousAntimetabolites, AntineoplasticImmunosuppressive AgentsMethotrexateSirolimusTacrolimus

Identifiers

PMID25840599
PMCPMC4486232
OpenAlexW2064152041

What OpenQuestion holds

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Registered trials

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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.