Evidence map›Paper›PMID 19713456›Full record

Trial reportBlood2009

Bortezomib, tacrolimus, and methotrexate for prophylaxis of graft-versus-host disease after reduced-intensity conditioning allogeneic stem cell transplantation from HLA-mismatched unrelated donors.

John Koreth, Kristen E Stevenson, Haesook T Kim, Michael Garcia, Vincent T Ho, Philippe Armand, Corey Cutler, Jerome Ritz, Joseph H Antin, Robert J Soiffer and 1 more

Registry-linked trialOpen access · greenAbstract readClinical Trial
In one paragraph

Trial report in Blood, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00369226 (Phase I/II Trial of Bortezomib), which is not on this map. Cited by 44 papers.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed
5.1field-weighted citation impact, top 4% 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.

NCT00369226 phase1 / phase2completednot on this map

Phase I/II Trial of Bortezomib (Velcade) in Addition to Tacrolimus and Methotrexate to Prevent Graft Versus Host Disease (GVHD) After Mismatched Allogeneic Non-Myeloablative Peripheral Blood Stem Cell Transplantation

TypeinterventionalSponsorDana-Farber Cancer InstituteRan2006 to 2011Enrolled45ConditionsHematologic MalignanciesArmsBortezomib (Velcade), Tacrolimus, Methotrexate, blood stem cell transplantation
3 · Its place in the literature

Who cites it

44 citing papers in PubMed, 90 citations in OpenAlex.

  1. Trial
  2. Ixazomib for Chronic Graft-versus-Host Disease Prophylaxis following Allogeneic Hematopoietic Cell Transplantation.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2020
    Trial
  3. Trial
  4. Trial
  5. A Bortezomib-Based Regimen Offers Promising Survival and Graft-versus-Host Disease Prophylaxis in Myeloablative HLA-Mismatched and Unrelated Donor Transplantation: A Phase II Trial.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2015
    Trial
  6. Trial
  7. A phase II study of bortezomib plus prednisone for initial therapy of chronic graft-versus-host disease.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2014
    Trial
  8. Bortezomib-based graft-versus-host disease prophylaxis in HLA-mismatched unrelated donor transplantation.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2012
    Trial
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Review
  15. Review
  16. Article
  17. Article
  18. Article
  19. New and emerging therapies for acute and chronic graftTherapeutic advances in hematology · 2018
    Review
  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

11 authors at 1 institution in 1 country.

John KorethDivision of Hematologic Malignancies, Dana-Farber Cancer Institute, Boston, MA 02115, USA. jkoreth@partners.org
Kristen E Stevenson
Haesook T Kim
Michael Garcia
Vincent T Ho
Philippe Armand
Corey Cutler
Jerome Ritz
Joseph H Antin
Robert J Soiffer
Edwin P Alyea
Dana-Farber Cancer Institute · US

Funding

Project 3: Humoral Targets and B Cell Biology in Chronic Graft-vs.-Host DiseaseP01CA142106 · NCI · DANA-FARBER CANCER INST · PI CUTLER, COREY S · 2009 to 2019
$17.5M
NCI NIH HHS P01 CA142106
6 · The paper itself

Abstract

Graft-versus-host disease (GVHD) is a significant complication of allogeneic stem cell transplantation (alloSCT). The proteasome inhibitor bortezomib has immunomodulatory properties of potential benefit for GVHD control. We undertook a phase 1 trial of bortezomib, tacrolimus, and methotrexate for GVHD prophylaxis after reduced-intensity conditioning alloSCT using human leukocyte antigen-mismatched unrelated donors. Twenty-three patients were enrolled. Bortezomib dose levels of 1, 1.3, and 1.5 mg/m2 were evaluated with 5, 3, and 5 patients, respectively. Ten additional patients were accrued at the 1.3 mg/m2 bortezomib dose level. Bortezomib-related toxicity was minimal. With a 12-month median follow-up, grade II-IV acute GVHD occurred in 3 patients, a 180-day cumulative incidence of 13%. Chronic GVHD occurred in 9 patients, a 1-year cumulative incidence of 41%. At 1-year, the nonrelapse mortality was zero, cumulative incidence of relapse/progression was 29%, and overall, progression-free, and event-free survival were 75%, 64%, and 59%, respectively. Bortezomib is a promising novel immunomodulatory agent in allogeneic transplantation. This study was registered at http://www.clinicaltrials.gov as #NCT00369226.

Indexed as

Living DonorsStem Cell TransplantationTransplantation ConditioningAntineoplastic Combined Chemotherapy ProtocolsBoronic AcidsBortezomibDisease-Free SurvivalFemaleFollow-Up StudiesGraft vs Host DiseaseHematologic NeoplasmsHumansMaleMethotrexatePyrazinesSurvival RateBoronic AcidsBortezomibMethotrexatePyrazinesTacrolimus

Identifiers

PMID19713456
PMCPMC2925723
OpenAlexW1977166918

What OpenQuestion holds

Textmetadata
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.