Evidence map›Paper›PMID 25644957›Full record

ArticleBiology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation2015

National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: III. The 2014 Biomarker Working Group Report.

Sophie Paczesny, Frances T Hakim, Joseph Pidala, Kenneth R Cooke, Julia Lathrop, Linda M Griffith, John Hansen, Madan Jagasia, David Miklos, Steven Pavletic and 8 more

Registry-linked trialAbstract readConsensus Development Conference, NIH
PubMed Full text at PMC Publisher
In one paragraph

Article in Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03605589 (A Pilot Study of Blinatumomab in Combination With a PD1 Inhibitor, Pembrolizumab, in Pediatric and Young Adult Patients With Relapsed/Refractory CD19 Positive B-cell Acute Leukemia or Lymphoma), which is not on this map. Cited by 95 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
95citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

NCT03605589 phase1withdrawnnot on this mapstarted 2018, after this paper: background citation

A Pilot Study of Blinatumomab in Combination With a PD1 Inhibitor, Pembrolizumab, in Pediatric and Young Adult Patients With Relapsed/Refractory CD19 Positive B-cell Acute Leukemia or Lymphoma

TypeinterventionalSponsorChildren's Hospital Medical Center, CincinnatiRan2018 to 2022Enrolled0ConditionsLeukemia, B-cell, Lymphoma, B-CellArmsBlinatumomab, Pembrolizumab
3 · Its place in the literature

Who cites it

95 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Guideline
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Diagnostic and Prognostic Plasma Biomarkers for Idiopathic Pneumonia Syndrome after Hematopoietic Cell Transplantation.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2018
    Trial
  8. Association of Plasma CD163 Concentration with De Novo-Onset Chronic Graft-versus-Host Disease.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2017
    Trial
  9. Observational
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Frontiers in immunology · 2026
    Article
  17. Review
  18. Review
  19. Article
  20. Review

35 more citing papers are in PubMed but not listed here.

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

18 authors.

Sophie PaczesnyDepartment of Pediatrics and Immunology, Indiana University of Medicine, Indianapolis, Indiana. Electronic address: sophpacz@iu.edu.
Frances T HakimExperimental Transplantation and Immunology Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
Joseph PidalaBlood and Marrow Transplantation, Moffitt Cancer Center, Tampa, Florida.
Kenneth R CookeDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Maryland.
Julia LathropOffice of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, Maryland.
Linda M GriffithDivision of Allergy, Immunology and Transplantation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.
John HansenClinical Research Division, Fred Hutchinson Cancer Research Center, and the Division of Medical Oncology, University of Washington School of Medicine, Seattle, Washington.
Madan JagasiaDepartment of Medicine, Division of Hematology-Oncology, Vanderbilt University Medical Center, Nashville, Tennessee.
David MiklosStanford Bone Marrow Transplant-Cellular Therapy Facility, Stanford University, Stanford, California.
Steven PavleticExperimental Transplantation and Immunology Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
Robertson ParkmanDepartment of Pediatrics, Children's Hospital of Los Angeles, University of Southern California, Los Angeles, California.
Estelle Russek-CohenDivision of Biostatistics, Center for Biologics, Food and Drug Administration, Silver Spring, Maryland.
Mary E D FlowersClinical Research Division, Fred Hutchinson Cancer Research Center, and the Division of Medical Oncology, University of Washington School of Medicine, Seattle, Washington.
Stephanie LeeClinical Research Division, Fred Hutchinson Cancer Research Center, and the Division of Medical Oncology, University of Washington School of Medicine, Seattle, Washington.
Paul MartinClinical Research Division, Fred Hutchinson Cancer Research Center, and the Division of Medical Oncology, University of Washington School of Medicine, Seattle, Washington.
Georgia VogelsangDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Maryland.
Marc WaltonOffice of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.
Kirk R SchultzMichael Cuccione Childhood Cancer Research Program, BC Children's Hospital and University of British Columbia, Vancouver, British Columbia, Canada.

Funding

Immune reconstitution following autologous and allogeneic stem cell transplantZICBC010934 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI FLOMERFELT, FRANCIS · 2009 to 2022
$10.0M
Biomarker Discovery in Chronic Graft-vs-Host DiseaseR01HL094260 · NHLBI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI HANSEN, JOHN ANDREW · 2008 to 2011
$1.8M
Intramural NIH HHS Z99 CA999999NHLBI NIH HHS R01 HL094260
6 · The paper itself

Abstract

Biology-based markers to confirm or aid in the diagnosis or prognosis of chronic graft-versus-host disease (GVHD) after allogeneic hematopoietic cell transplantation or monitor its progression are critically needed to facilitate evaluation of new therapies. Biomarkers have been defined as any characteristic that is objectively measured and evaluated as an indicator of a normal biological or pathogenic process, or of a pharmacologic response to a therapeutic intervention. Applications of biomarkers in chronic GVHD clinical trials or patient management include the following: (1) diagnosis and assessment of chronic GVHD disease activity, including distinguishing irreversible damage from continued disease activity; (2) prognostic risk to develop chronic GVHD; and (3) prediction of response to therapy. Sample collection for chronic GVHD biomarkers studies should be well documented following established quality control guidelines for sample acquisition, processing, preservation, and testing, at intervals that are both calendar and event driven. The consistent therapeutic treatment of subjects and standardized documentation needed to support biomarker studies are most likely to be provided in prospective clinical trials. To date, no chronic GVHD biomarkers have been qualified for use in clinical applications. Since our previous chronic GVHD Biomarkers Working Group report in 2005, an increasing number of chronic GVHD candidate biomarkers are available for further investigation. This paper provides a 4-part framework for biomarker investigations: identification, verification, qualification, and application with terminology based on Food and Drug Administration and European Medicines Agency guidelines.

Indexed as

Clinical Trials as TopicBiomarkersGraft vs Host DiseaseHumansPrognosisTerminology as TopicUnited StatesUnited States Food and Drug AdministrationBiomarkersBiomarkersChronic graft-versus-host diseaseConsensusNational Institutes of Health

Identifiers

PMID25644957
PMCPMC4408233

What OpenQuestion holds

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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.