Evidence map›Paper›PMID 25985921›Full record

ReviewBiology 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: VI. The 2014 Clinical Trial Design Working Group Report.

Paul J Martin, Stephanie J Lee, Donna Przepiorka, Mary M Horowitz, John Koreth, Georgia B Vogelsang, Irwin Walker, Paul A Carpenter, Linda M Griffith, Gorgun Akpek and 4 more

2 registry-linked trialsAbstract readHistorical ArticleReviewConsensus Statement
In one paragraph

Review 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 2 registered trials, which are not on this map. Cited by 64 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
64citing papers in PubMed, 1 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.

NCT03608059 phase4completednot on this mapstarted 2018, after this paper: background citation

Shanghai General Hospital Affiliated to Shanghai Jiao Tong University

TypeinterventionalSponsorShanghai General Hospital, Shanghai Jiao Tong University School of MedicineRan2018 to 2023Enrolled418ConditionsMyeloid TumorArmsATG/PTCy, standard ATG, standard PTCy
NCT06756061 phase2recruitingnot on this mapstarted 2025, after this paper: background citation

A Nation-wide, Multi-center, Prospective, Randomized, Parallel-group, Open-label, Investigator Initiated Pilot Study to Evaluate Efficacy and Safety of Systemic Corticosteroid Plus Ruxolitinib as First-line Therapy in Patients With New-onset Moderate to Severe Chronic Graft-versus-host Disease

TypeinterventionalSponsorByung-Sik ChoRan2025 to 2029Enrolled88ConditionsGVHD - Graft-Versus-Host Disease, Neoplasms, Haematopoietic Stem Cell TransplantationArmsPrednisone + Jakavi(ruxolitinib), Prednisone
3 · Its place in the literature

Who cites it

64 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Guideline
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Anti-Platelet-Derived Growth Factor Receptor Alpha Chain Antibodies Predict for Response to Nilotinib in Steroid-Refractory or -Dependent Chronic Graft-Versus-Host Disease.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2018
    Trial
  8. Article
  9. Article
  10. Article
  11. Review
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. Review

4 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

14 authors.

Paul J MartinClinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington. Electronic address: pmartin@fredhutch.org.
Stephanie J LeeClinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.
Donna PrzepiorkaCenter for Drug Evaluation Research, US Food and Drug Administration, Silver Spring, Maryland.
Mary M HorowitzDivision of Hematology and Oncology, Medical College of Wisconsin, Milwaukee, Wisconsin.
John KorethDivision of Hematologic Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.
Georgia B VogelsangDepartment of Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Irwin WalkerDepartment of Medicine, McMaster University, Hamilton, Ontario, Canada.
Paul A CarpenterClinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.
Linda M GriffithDivision of Allergy, Immunology and Transplantation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.
Gorgun AkpekStem Cell Transplant Program, Banner MD Anderson Cancer Center, Gilbert, Arizona.
Mohamad MohtyClinical Hematology and Cellular Therapy Department, Hôpital Saint-Antoine, University Pierre & Marie Curie, INSERM U938, Paris, France.
Daniel WolffDepartment of Internal Medicine III, University of Regensburg, Regensburg, Germany.
Steven Z PavleticCenter for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
Corey S CutlerDivision of Hematologic Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.

Funding

VIRUS-MEDIATED MYELOSUPPRESSIONP01CA018029 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Geoffrey Roger HILL · 1985 to 2026
$128.4M
Data Resource for Analyzing Blood &Marrow TransplantsU24CA076518 · NCI · MEDICAL COLLEGE OF WISCONSIN · PI Amy M Moskop, Bronwen Shaw · 1998 to 2026
$105.2M
Improving Outcomes Assessment in Chronic GVHDR01CA118953 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI LEE, STEPHANIE J · 2011 to 2025
$8.3M
Improving Outcomes Assessment in Chronic GVHDU01CA118953 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI LEE, STEPHANIE J · 2007 to 2010
$3.1M
Intramural NIH HHSNCI NIH HHS CA118953NCI NIH HHS CA18029NCI NIH HHS P01 CA018029NCI NIH HHS R01 CA118953NCI NIH HHS U01 CA118953NCI NIH HHS U24 CA076518
6 · The paper itself

Abstract

Treatment of chronic graft-versus-host disease is intended to produce a sustainable benefit by reducing symptom burden, controlling objective manifestations of disease activity, preventing damage and impairment, and improving overall survival without causing disproportionate harms related to the treatment itself. Successful management can control the disease until systemic treatment is no longer needed. The complexity of the disease, the extended duration of follow-up needed to observe disease resolution and withdrawal of immunosuppressive treatment, and the lack of fully developed shorter term endpoints impede progress in the field. Identification and characterization of primary endpoints demonstrating clinical benefit without requiring years of follow-up is urgently needed, with the understanding that clinical benefit encompasses not only the self-evident benefit of the primary endpoint but also any other associated benefits. This report discusses regulatory considerations, eligibility criteria, the value of controlled trial designs, the merits of proposed primary endpoints, and key considerations elaborated from experience and progress during the past decade. The report concludes by mapping an overall approach that could support and lead to maximally informative clinical trials, especially those that seek to demonstrate clinical benefit along a pathway to regulatory review and approval.

Indexed as

Clinical Trials as TopicGraft vs Host DiseaseHistory, 21st CenturyHumansNational Institutes of Health (U.S.)United StatesAllogeneic hematopoietic cell transplantationChronic graft-versus-host diseaseClinical trialsConsensusDesignGuidelines

Identifiers

PMID25985921
PMCPMC4506719

What OpenQuestion holds

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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.