Evidence map›Paper›PMID 21689773›Full record

Trial reportBiology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation2012

Randomized trial of hydroxychloroquine for newly diagnosed chronic graft-versus-host disease in children: a Children's Oncology Group study.

Andrew L Gilman, Kirk R Schultz, Frederick D Goldman, George E Sale, Mark D Krailo, Zhengjia Chen, Bryan Langholz, David A Jacobsohn, Ka-Wah Chan, Robin E Ryan and 8 more

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00031824 (Phase III Trial of Hydroxychloroquine + Standard Therapy for Chronic Graft-Versus-Host Disease), which is not on this map. Cited by 30 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing 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.

NCT00031824 phase3completednot on this map

Phase III Trial of Hydroxychloroquine + Standard Therapy for Chronic Graft-Versus-Host Disease

TypeinterventionalSponsorChildren's Oncology GroupRan2002 to 2011Enrolled82ConditionsGraft Versus Host DiseaseArmscyclosporine, hydroxychloroquine, prednisone, tacrolimus
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Trial
  3. Ibrutinib for First-Line Treatment of Chronic Graft-Versus-Host Disease: Results From the Randomized Phase III iNTEGRATE Study.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023
    Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Article
  9. Article
  10. Review
  11. Modern-Era Challenges in the Clinical Management of Graft-Versus-Host Disease.Advances in experimental medicine and biology · 2025
    Review
  12. Review
  13. Review
  14. Article
  15. Article
  16. Article
  17. Review
  18. Review
  19. Article
  20. 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

18 authors.

Andrew L GilmanLevine Children's Hospital, Charlotte, North Carolina 28232, USA. andrew.gilman@carolinashealthcare.org
Kirk R Schultz
Frederick D Goldman
George E Sale
Mark D Krailo
Zhengjia Chen
Bryan Langholz
David A Jacobsohn
Ka-Wah Chan
Robin E Ryan
Michael Kellick
Steven M Neudorf
Kamar Godder
Eric S Sandler
Indira Sahdev
Stephan A Grupp
Jean E Sanders
Donna A Wall

Funding

COG FOREIGN ACCRUALU10CA098543 · NCI · NATIONAL CHILDHOOD CANCER FOUNDATION · PI ADAMSON, PETER C. · 2003 to 2013
$335.5M
Translational Bioimaging Core Shared ResourceP30CA015704 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Marian Esvelt · 1985 to 2026
$296.4M
Children's Oncology Group Statistics &Data Center GrantU10CA098413 · NCI · UNIVERSITY OF NEBRASKA MEDICAL CENTER · PI DEVIDAS, MEENAKSHI · 2003 to 2013
$67.5M
HYDROXYCHLOROQUINE THERAPY AND BIOLOGY OF GVHDR01CA084137 · NCI · UNIVERSITY OF NORTH CAROLINA CHAPEL HILL · PI GILMAN, ANDREW L · 2000 to 2004
$2.1M
NCI NIH HHS P30 CA015704NCI NIH HHS R01 CA084137NCI NIH HHS R01 CA 84137NCI NIH HHS U10 CA098413NCI NIH HHS U10 CA098543NCI NIH HHS U10 CA98413NCI NIH HHS U10 CA98543
6 · The paper itself

Abstract

The Children's Oncology Group conducted a multicenter Phase III trial for chronic graft-versus-host disease (cGVHD). The double-blind, placebo-controlled, randomized study evaluated hydroxychloroquine added to standard therapy for children with newly diagnosed cGVHD. The study also used a novel grading and response scoring system and evaluated clinical laboratory correlates of cGVHD. The primary endpoint was complete response (CR) after 9 months of therapy. Fifty-four patients (27 on each arm) were enrolled before closure because of slow accrual. The CR rate was 28% in the hydroxychloroquine arm versus 33% in the placebo arm (odds ratio [OR] = 0.77, 95% confidence interval [CI]: 0.20-2.93, P = .75) for 42 evaluable patients. For 41 patients with severity assessment at enrollment, 20 (49%) were severe and 18 (44%) moderate according to the National Institutes of Health Consensus Conference global scoring system. The CR rate was 15% for severe cGVHD and 44% for moderate cGVHD (OR = 0.24, 95% CI: 0.05-1.06, P = .07). Although the study could not resolve the primary question, it provided important information for future cGVHD study design in this population.

Indexed as

AdolescentAdultChildChild, PreschoolChronic DiseaseDouble-Blind MethodFemaleGraft vs Host DiseaseHumansHydroxychloroquineInfantMaleTreatment OutcomeYoung AdultHydroxychloroquine

Identifiers

PMID21689773
PMCPMC4627789

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.