Evidence map›Paper›PMID 26055298›Full record

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

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.

John Koreth, Haesook T Kim, Paulina B Lange, Bhavjot Bindra, Carol G Reynolds, Marie J Chammas, Philippe Armand, Corey S Cutler, Vincent T Ho, Brett Glotzbecker and 6 more

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

Trial report 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 NCT01323920 (Bortezomib-based Graft-Versus-Host-Disease Prophylaxis After Myeloablative Allogeneic Stem Cell Transplantation for Patients Lacking HLA-matched Related Donors), which is not on this map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
2.5field-weighted citation impact, top 11% 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.

NCT01323920 phase2completednot on this map

Bortezomib-based Graft-Versus-Host-Disease Prophylaxis After Myeloablative Allogeneic Stem Cell Transplantation for Patients Lacking HLA-matched Related Donors: A Phase 2 Study

TypeinterventionalSponsorDana-Farber Cancer InstituteRan2011 to 2013Enrolled35ConditionsLeukemia, Lymphoma, Myelodysplastic SyndromeArmsBortezomib, Tacrolimus, Methotrexate
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 31 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. Allogeneic Transplantation after Myeloablative Rituximab/BEAM ± Bortezomib for Patients with Relapsed/Refractory Lymphoid Malignancies: 5-Year Follow-Up Results.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2019
    Trial
  5. Graft-Versus-Host Disease Mouse Models: A Clinical-Translational Perspective.Methods in molecular biology (Clifton, N.J.) · 2025
    Review
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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

16 authors at 3 institutions in 1 country.

John KorethDivision of Hematologic Malignancies, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts. Electronic address: john_koreth@dfci.harvard.edu.
Haesook T KimDepartment of Biostatistics & Computational Biology, Dana-Farber Cancer Institute and Harvard School of Public Health, Boston, Massachusetts.
Paulina B LangeDivision of Hematologic Malignancies, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.
Bhavjot BindraDivision of Hematologic Malignancies, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.
Carol G ReynoldsDivision of Hematologic Malignancies, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.
Marie J ChammasDivision of Hematologic Malignancies, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.
Philippe ArmandDivision of Hematologic Malignancies, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.
Corey S CutlerDivision of Hematologic Malignancies, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.
Vincent T HoDivision of Hematologic Malignancies, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.
Brett GlotzbeckerDivision of Hematologic Malignancies, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.
Sarah NikiforowDivision of Hematologic Malignancies, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.
Jerome RitzDivision of Hematologic Malignancies, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.
Bruce R BlazarDivision of Blood and Marrow Transplantation, University of Minnesota Masonic Cancer Center and Department of Pediatrics, Minneapolis, Minnesota.
Robert J SoifferDivision of Hematologic Malignancies, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.
Joseph H AntinDivision of Hematologic Malignancies, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.
Edwin P AlyeaDivision of Hematologic Malignancies, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.
Dana-Farber Cancer Institute · USHarvard University · USUniversity of Minnesota Medical Center · 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
Novel Approaches to GHVD PreventionP01HL070149 · NHLBI · DANA-FARBER CANCER INSTITUTE · PI LEE, STEPHANIE J · 2003 to 2007
$10.2M
Manipulation of Immune Responsiveness after Hematopoietic Cell TransplantationR01CA183559 · NCI · DANA-FARBER CANCER INST · PI RITZ, JEROME, SOIFFER, ROBERT JON · 2013 to 2017
$3.7M
Reconstitution of Regulatory T Cells After Stem Cell TransplantationR01CA183560 · NCI · DANA-FARBER CANCER INST · PI RITZ, JEROME, SOIFFER, ROBERT JON · 2013 to 2017
$2.5M
NCI NIH HHS CA183559NCI NIH HHS CA183560NCI NIH HHS P01 CA142106NCI NIH HHS P01CA142106NCI NIH HHS R01 CA183559NCI NIH HHS R01 CA183560NHLBI NIH HHS P01 HL070149
6 · The paper itself

Abstract

Hematopoietic stem cell transplantation (HSCT) recipients lacking HLA-matched related donors have increased graft-versus-host disease (GVHD) and nonrelapse mortality (NRM). Bortezomib added to reduced-intensity conditioning can offer benefit in T cell-replete HLA-mismatched HSCT and may also benefit myeloablative conditioning (MAC) transplants. We conducted a phase II trial of short-course bortezomib plus standard tacrolimus/methotrexate after busulfan/fludarabine MAC in 34 patients with predominantly myeloid malignancies. Fourteen (41%) received 8/8 HLA-matched unrelated donor (MUD) and 20 (59%) received 7/8 HLA-mismatched related/unrelated donor peripheral blood stem cell grafts. Median age was 49 years (range, 21 to 60), and median follow-up was 25 months (range, 11 to 36). The regimen was well tolerated. No dose modifications were required. Neutrophil and platelet engraftment occurred at a median of 14 (range, 10 to 33) and 17 (range, 10 to 54) days, respectively. Median 30-day donor chimerism was 99% (range, 90 to 100), and 100-day grades II to IV and III to IV acute GVHD incidence was 32% and 12% respectively. One-year chronic GVHD incidence was 50%. Two-year cumulative incidence of both NRM and relapse was 16%. Two-year progression-free and overall survival rates were 70% and 71%, respectively. Outcomes were comparable to an 8/8 MUD MAC cohort (n = 45). Immune reconstitution was robust. Bortezomib-based MAC HSCT is well tolerated, with HLA-mismatched outcomes comparable with 8/8 MUD MAC HSCT, and is suitable for randomized evaluation. (clinicaltrials.gov: NCT01323920.).

Indexed as

Hematopoietic Stem Cell TransplantationAdultBortezomibBusulfanFemaleFollow-Up StudiesGraft vs Host DiseaseHematologic NeoplasmsHistocompatibility TestingHumansMaleMethotrexateMiddle AgedMyeloablative AgonistsSurvival AnalysisTacrolimusBortezomibBusulfanfludarabineMethotrexateMyeloablative AgonistsTacrolimusVidarabineAllogeneicHLA mismatchMyeloablativeProteasome inhibitorT cell repleteTransplantation

Identifiers

PMID26055298
PMCPMC4604028
OpenAlexW1799226444

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.