Evidence map›Paper›PMID 28784598›Full record

Trial reportBlood2017

Vorinostat plus tacrolimus/methotrexate to prevent GVHD after myeloablative conditioning, unrelated donor HCT.

Sung Won Choi, Thomas Braun, Israel Henig, Erin Gatza, John Magenau, Brian Parkin, Attaphol Pawarode, Mary Riwes, Greg Yanik, Charles A Dinarello and 1 more

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Blood, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01790568 (Pilot Trial of Vorinostat Plus Tacrolimus & Methotrexate to Prevent Graft Versus Host Disease Following Unrelated Donor Allogeneic Transplant), which is not on this map. Cited by 47 papers.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed
–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.

NCT01790568 phase2completednot on this map

Pilot Trial of Vorinostat Plus Tacrolimus & Methotrexate to Prevent Graft Versus Host Disease Following Unrelated Donor Allogeneic Transplant

TypeinterventionalSponsorUniversity of Michigan Rogel Cancer CenterRan2014 to 2017Enrolled26ConditionsGraft vs Host Disease, Hematologic Neoplasms, Non-Neoplastic Hematologic and Lymphocytic DisorderArmsVorinostat, Tacrolimus, Methotrexate
3 · Its place in the literature

Who cites it

47 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
  4. Trial
  5. Cognitive Function and Quality of Life in Vorinostat-Treated Patients after Matched Unrelated Donor Myeloablative Conditioning Hematopoietic Cell Transplantation.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2019
    Trial
  6. Review
  7. Review
  8. Review
  9. Epigenetic factors associated with peri-implantitis: a review.Journal of Zhejiang University. Science. B · 2025
    Review
  10. Review
  11. Graft-Versus-Host Disease Mouse Models: A Clinical-Translational Perspective.Methods in molecular biology (Clifton, N.J.) · 2025
    Review
  12. Review
  13. Review
  14. Article
  15. Review
  16. Novel approaches to acute graft-versus-host disease prevention.Hematology. American Society of Hematology. Education Program · 2023
    Review
  17. Article
  18. Review
  19. Review
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors.

Sung Won ChoiDepartment of Pediatrics, Michigan Medicine, Ann Arbor, MI.
Thomas BraunDepartment of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, MI.
Israel HenigDepartment of Medicine, Michigan Medicine, Ann Arbor, MI.
Erin GatzaDepartment of Pediatrics, Michigan Medicine, Ann Arbor, MI.
John MagenauDepartment of Medicine, Michigan Medicine, Ann Arbor, MI.
Brian ParkinDepartment of Medicine, Michigan Medicine, Ann Arbor, MI.
Attaphol PawarodeDepartment of Medicine, Michigan Medicine, Ann Arbor, MI.
Mary RiwesDepartment of Medicine, Michigan Medicine, Ann Arbor, MI.
Greg YanikDepartment of Pediatrics, Michigan Medicine, Ann Arbor, MI.
Charles A DinarelloDepartment of Medicine, University of Colorado, Aurora, CO; and.
Pavan ReddyDepartment of Medicine, Michigan Medicine, Ann Arbor, MI.

Funding

XenograftP30CA046592 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI Alexey I Nesvizhskii · 1988 to 2026
$178.2M
Transforming Translational Science and Education to Benefit Human HealthUL1TR000043 · NCATS · ROCKEFELLER UNIVERSITY · PI COLLER, BARRY · 2012 to 2015
$26.8M
Vorinostat for GVHD prevention in unrelated donor myeloblative conditioning BMTR21CA198776 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI CHOI, SUNG WON · 2015 to 2016
$371k
NCATS NIH HHS UL1 TR000043NCI NIH HHS P30 CA046592NCI NIH HHS R21 CA198776
6 · The paper itself

Abstract

The oral histone deacetylase (HDAC) inhibitor (vorinostat) is safe and results in low incidence of acute graft-versus-host disease (GVHD) after reduced-intensity conditioning, related donor hematopoietic cell transplantation (HCT). However, its safety and efficacy in preventing acute GVHD in settings of heightened clinical risk that use myeloablative conditioning, unrelated donor (URD), and methotrexate are not known. We conducted a prospective, phase 2 study in this higher-risk setting. We enrolled 37 patients to provide 80% power to detect a significant difference in grade 2 to 4 acute GVHD of 50% compared with a reduction in target to 28%. Eligibility included adults with a hematological malignancy to receive myeloablative HCT from an available 8/8-HLA matched URD. Patients received GVHD prophylaxis with tacrolimus and methotrexate. Vorinostat (100 mg twice daily) was started on day -10 and continued through day +100 post-HCT. Median age was 56 years (range, 18-69 years), and 95% had acute myelogenous leukemia or high-risk myelodysplastic syndrome. Vorinostat was safe and tolerable. The cumulative incidence of grade 2 to 4 acute GVHD at day 100 was 22%, and for grade 3 to 4 it was 8%. The cumulative incidence of chronic GVHD was 29%; relapse, nonrelapse mortality, GVHD-free relapse-free survival, and overall survival at 1 year were 19%, 16%, 47%, and 76%, respectively. Correlative analyses showed enhanced histone (H3) acetylation in peripheral blood mononuclear cells and reduced interleukin 6 (

Indexed as

Unrelated DonorsAcetylationAcute DiseaseAdolescentAdultAgedDemographyFeasibility StudiesFemaleGraft vs Host DiseaseHematopoietic Stem Cell TransplantationHistone Deacetylase InhibitorsHistonesHumansHydroxamic AcidsIncidenceHistone Deacetylase InhibitorsHistonesHydroxamic AcidsMethotrexateTacrolimusVorinostat

Identifiers

PMID28784598
PMCPMC5639486

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.