Evidence map›Paper›PMID 25267759›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2014

Multi-institutional study of post-transplantation cyclophosphamide as single-agent graft-versus-host disease prophylaxis after allogeneic bone marrow transplantation using myeloablative busulfan and fludarabine conditioning.

Christopher G Kanakry, Paul V O'Donnell, Terry Furlong, Marcos J de Lima, Wei Wei, Marta Medeot, Marco Mielcarek, Richard E Champlin, Richard J Jones, Peter F Thall and 2 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00809276 (Trial of Allogeneic BMT for Hematologic Malignancies Using HLA-matched Related or Unrelated Donors With Fludarabine and IV Busulfan as Pre-transplant Conditioning Followed by Post-transplant Immunosuppression With High-dose Cyclophosphamide), which is not on this map. Cited by 164 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
164citing papers in PubMed, 4 pooled it
14.3field-weighted citation impact, top 1% 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.

NCT00809276 phase1 / phase2completednot on this map

Trial of Allogeneic BMT for Hematologic Malignancies Using HLA-matched Related or Unrelated Donors With Fludarabine and IV Busulfan as Pre-transplant Conditioning Followed by Post-transplant Immunosuppression With High-dose Cyclophosphamide

TypeinterventionalSponsorSidney Kimmel Comprehensive Cancer Center at Johns HopkinsRan2009 to 2011Enrolled92ConditionsLymphoma, Multiple Myeloma, Leukemia, Myelodysplastic SyndromeArmsBusulfan, Fludarabine, Cytoxan
3 · Its place in the literature

Who cites it

164 citing papers in PubMed, 4 syntheses or guidelines pooled it, 277 citations in OpenAlex.

  1. Pooled it
  2. Post-transplant cyclophosphamideFrontiers in oncology · 2023
    Pooled it
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  11. Naive T-Cell Depletion to Prevent Chronic Graft-Versus-Host Disease.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2022
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  18. Allogeneic Hematopoietic Cell Transplant for HIV Patients with Hematologic Malignancies: The BMT CTN-0903/AMC-080 Trial.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2019
    Trial
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  20. Reduced-Intensity Conditioning Followed by Related and Unrelated Allografts for Hematologic Malignancies: Expanded Analysis and Long-Term Follow-Up.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2019
    Trial

104 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

12 authors at 3 institutions in 1 country.

Christopher G KanakryChristopher G. Kanakry, Marta Medeot, Richard J. Jones, Leo Luznik, Sidney Kimmel Comprehensive Cancer Center, The Johns Hopkins University School of Medicine, Baltimore, MD; Paul V. O'Donnell, Terry Furlong, Marco Mielcarek, Fred Hutchinson Cancer Research Center, Seattle, WA; Marcos J. de Lima, Wei Wei, Richard E. Champlin, Peter F. Thall, Borje S. Andersson, The University of Texas MD Anderson Cancer Center, Houston, TX.
Paul V O'DonnellChristopher G. Kanakry, Marta Medeot, Richard J. Jones, Leo Luznik, Sidney Kimmel Comprehensive Cancer Center, The Johns Hopkins University School of Medicine, Baltimore, MD; Paul V. O'Donnell, Terry Furlong, Marco Mielcarek, Fred Hutchinson Cancer Research Center, Seattle, WA; Marcos J. de Lima, Wei Wei, Richard E. Champlin, Peter F. Thall, Borje S. Andersson, The University of Texas MD Anderson Cancer Center, Houston, TX.
Terry FurlongChristopher G. Kanakry, Marta Medeot, Richard J. Jones, Leo Luznik, Sidney Kimmel Comprehensive Cancer Center, The Johns Hopkins University School of Medicine, Baltimore, MD; Paul V. O'Donnell, Terry Furlong, Marco Mielcarek, Fred Hutchinson Cancer Research Center, Seattle, WA; Marcos J. de Lima, Wei Wei, Richard E. Champlin, Peter F. Thall, Borje S. Andersson, The University of Texas MD Anderson Cancer Center, Houston, TX.
Marcos J de LimaChristopher G. Kanakry, Marta Medeot, Richard J. Jones, Leo Luznik, Sidney Kimmel Comprehensive Cancer Center, The Johns Hopkins University School of Medicine, Baltimore, MD; Paul V. O'Donnell, Terry Furlong, Marco Mielcarek, Fred Hutchinson Cancer Research Center, Seattle, WA; Marcos J. de Lima, Wei Wei, Richard E. Champlin, Peter F. Thall, Borje S. Andersson, The University of Texas MD Anderson Cancer Center, Houston, TX.
Wei WeiChristopher G. Kanakry, Marta Medeot, Richard J. Jones, Leo Luznik, Sidney Kimmel Comprehensive Cancer Center, The Johns Hopkins University School of Medicine, Baltimore, MD; Paul V. O'Donnell, Terry Furlong, Marco Mielcarek, Fred Hutchinson Cancer Research Center, Seattle, WA; Marcos J. de Lima, Wei Wei, Richard E. Champlin, Peter F. Thall, Borje S. Andersson, The University of Texas MD Anderson Cancer Center, Houston, TX.
Marta MedeotChristopher G. Kanakry, Marta Medeot, Richard J. Jones, Leo Luznik, Sidney Kimmel Comprehensive Cancer Center, The Johns Hopkins University School of Medicine, Baltimore, MD; Paul V. O'Donnell, Terry Furlong, Marco Mielcarek, Fred Hutchinson Cancer Research Center, Seattle, WA; Marcos J. de Lima, Wei Wei, Richard E. Champlin, Peter F. Thall, Borje S. Andersson, The University of Texas MD Anderson Cancer Center, Houston, TX.
Marco MielcarekChristopher G. Kanakry, Marta Medeot, Richard J. Jones, Leo Luznik, Sidney Kimmel Comprehensive Cancer Center, The Johns Hopkins University School of Medicine, Baltimore, MD; Paul V. O'Donnell, Terry Furlong, Marco Mielcarek, Fred Hutchinson Cancer Research Center, Seattle, WA; Marcos J. de Lima, Wei Wei, Richard E. Champlin, Peter F. Thall, Borje S. Andersson, The University of Texas MD Anderson Cancer Center, Houston, TX.
Richard E ChamplinChristopher G. Kanakry, Marta Medeot, Richard J. Jones, Leo Luznik, Sidney Kimmel Comprehensive Cancer Center, The Johns Hopkins University School of Medicine, Baltimore, MD; Paul V. O'Donnell, Terry Furlong, Marco Mielcarek, Fred Hutchinson Cancer Research Center, Seattle, WA; Marcos J. de Lima, Wei Wei, Richard E. Champlin, Peter F. Thall, Borje S. Andersson, The University of Texas MD Anderson Cancer Center, Houston, TX.
Richard J JonesChristopher G. Kanakry, Marta Medeot, Richard J. Jones, Leo Luznik, Sidney Kimmel Comprehensive Cancer Center, The Johns Hopkins University School of Medicine, Baltimore, MD; Paul V. O'Donnell, Terry Furlong, Marco Mielcarek, Fred Hutchinson Cancer Research Center, Seattle, WA; Marcos J. de Lima, Wei Wei, Richard E. Champlin, Peter F. Thall, Borje S. Andersson, The University of Texas MD Anderson Cancer Center, Houston, TX.
Peter F ThallChristopher G. Kanakry, Marta Medeot, Richard J. Jones, Leo Luznik, Sidney Kimmel Comprehensive Cancer Center, The Johns Hopkins University School of Medicine, Baltimore, MD; Paul V. O'Donnell, Terry Furlong, Marco Mielcarek, Fred Hutchinson Cancer Research Center, Seattle, WA; Marcos J. de Lima, Wei Wei, Richard E. Champlin, Peter F. Thall, Borje S. Andersson, The University of Texas MD Anderson Cancer Center, Houston, TX.
Borje S AnderssonChristopher G. Kanakry, Marta Medeot, Richard J. Jones, Leo Luznik, Sidney Kimmel Comprehensive Cancer Center, The Johns Hopkins University School of Medicine, Baltimore, MD; Paul V. O'Donnell, Terry Furlong, Marco Mielcarek, Fred Hutchinson Cancer Research Center, Seattle, WA; Marcos J. de Lima, Wei Wei, Richard E. Champlin, Peter F. Thall, Borje S. Andersson, The University of Texas MD Anderson Cancer Center, Houston, TX.
Leo LuznikChristopher G. Kanakry, Marta Medeot, Richard J. Jones, Leo Luznik, Sidney Kimmel Comprehensive Cancer Center, The Johns Hopkins University School of Medicine, Baltimore, MD; Paul V. O'Donnell, Terry Furlong, Marco Mielcarek, Fred Hutchinson Cancer Research Center, Seattle, WA; Marcos J. de Lima, Wei Wei, Richard E. Champlin, Peter F. Thall, Borje S. Andersson, The University of Texas MD Anderson Cancer Center, Houston, TX. luznile@jhmi.edu.
Cancer Research Center · USThe University of Texas MD Anderson Cancer Center · USFred Hutch Cancer Center · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
TUMOR VACCINESP01CA015396 · NCI · JOHNS HOPKINS UNIVERSITY · PI HESS, ALLAN D · 1985 to 2016
$38.1M
Deciphering the efficacy of posttransplant cyclophosphamide in haplo transplantZIABC011659 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI KANAKRY, CHRISTOPHER · 2015 to 2025
$18.5M
TRAINING PROGRAM IN HEMATOLOGYT32HL007525 · NHLBI · JOHNS HOPKINS UNIVERSITY · PI ROBERT A BRODSKY · 1985 to 2026
$6.2M
Statins for Prevention of GVHDR01HL108307 · NHLBI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI MIELCAREK, MARCO B · 2011 to 2015
$2.2M
NCI NIH HHS P01 CA015396NCI NIH HHS P01-CA015396NCI NIH HHS P30 CA016672NHLBI NIH HHS R01 HL108307NHLBI NIH HHS T32 HL007525
6 · The paper itself

Abstract

purposeThe clinical safety and efficacy of intravenous busulfan and fludarabine (IV Bu/Flu) myeloablative conditioning as well as graft-versus-host disease (GVHD) prophylaxis with high-dose, post-transplantation cyclophosphamide (PTCy) have been demonstrated independently in several single-institutional studies. We hypothesized that combining these two promising approaches in a multi-institutional study of human leukocyte antigen (HLA) -matched bone marrow transplantation would provide low rates of severe acute and chronic GVHD, low toxicity, and effective disease control. PATIENTS AND

methodsNinety-two adult patients (median age, 49 years; range, 21 to 65 years) with high-risk hematologic malignancies were enrolled at three centers (clinical trial No. NCT00809276). Forty-five patients received related allografts, and 47 received unrelated allografts. GVHD prophylaxis was solely with PTCy at 50 mg/kg/day on post-transplantation days +3 and +4.

resultsThe cumulative incidences of grades 2 to 4 acute, grades 3 to 4 acute, and chronic GVHD were 51%, 15%, and 14%, respectively. Nonrelapse mortality (NRM) at 100 days and 1 year were 9% and 16%, respectively. With a median follow-up period of 2.2 years, the 2-year disease-free survival (DFS) and overall survival (OS) rates were 62% and 67%, respectively. Donor relatedness did not affect NRM, DFS, or OS. Patients in complete remission (CR) without evidence of minimal residual disease (MRD) had markedly better DFS (80%) and OS (80%) than patients in CR with MRD or with active disease at the time of transplantation (DFS, P = .0005; OS, P = .019).

conclusionThis multi-institutional study demonstrates that PTCy can be safely and effectively combined with IV Bu/Flu myeloablative conditioning and confirms PTCy's efficacy as single-agent, short-course GVHD prophylaxis for both acute and chronic GVHD after bone marrow transplantation from HLA-matched donors.

Indexed as

Hematopoietic Stem Cell TransplantationAdultAgedBayes TheoremBusulfanCyclophosphamideFemaleGraft vs Host DiseaseHumansImmunosuppressive AgentsIncidenceMaleMiddle AgedMyeloablative AgonistsTransplantation ConditioningTreatment OutcomeBusulfanCyclophosphamidefludarabineImmunosuppressive AgentsMyeloablative AgonistsVidarabine

Identifiers

PMID25267759
PMCPMC4209101
OpenAlexW2169530433

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.