Evidence map›Paper›PMID 26764356›Full record

Trial reportBlood2016

Posttransplantation cyclophosphamide for prevention of graft-versus-host disease after HLA-matched mobilized blood cell transplantation.

Marco Mielcarek, Terry Furlong, Paul V O'Donnell, Barry E Storer, Jeannine S McCune, Rainer Storb, Paul A Carpenter, Mary E D Flowers, Frederick R Appelbaum, Paul J Martin

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

Trial report in Blood, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01427881 (A Phase II Study to Evaluate the Efficacy of Posttransplant Cyclophosphamide for Prevention of Chronic Graft-versus-Host Disease After Allogeneic Peripheral Blood Stem Cell Transplantation), which is not on this map. Cited by 127 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
127citing papers in PubMed, 4 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.

NCT01427881 phase2completednot on this map

A Phase II Study to Evaluate the Efficacy of Posttransplant Cyclophosphamide for Prevention of Chronic Graft-versus-Host Disease After Allogeneic Peripheral Blood Stem Cell Transplantation

TypeinterventionalSponsorFred Hutchinson Cancer CenterRan2011 to 2015Enrolled43ConditionsAccelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Myeloid Leukemia in RemissionArmscyclophosphamide, cyclosporine, peripheral blood stem cell transplantation, total-body irradiation, fludarabine phosphate
3 · Its place in the literature

Who cites it

127 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
  2. Post-transplant cyclophosphamideFrontiers in oncology · 2023
    Pooled it
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  13. 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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  20. Impact of T Cell Dose on Outcome of T Cell-Replete HLA-Matched Allogeneic Peripheral Blood Stem Cell Transplantation.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2019
    Trial

67 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

10 authors.

Marco MielcarekDivision of Clinical Research, Fred Hutchinson Cancer Research Center, Seattle, WA; and Department of Medicine.
Terry FurlongDivision of Clinical Research, Fred Hutchinson Cancer Research Center, Seattle, WA; and.
Paul V O'DonnellDivision of Clinical Research, Fred Hutchinson Cancer Research Center, Seattle, WA; and Department of Medicine.
Barry E StorerDivision of Clinical Research, Fred Hutchinson Cancer Research Center, Seattle, WA; and Department of Biostatistics.
Jeannine S McCuneDivision of Clinical Research, Fred Hutchinson Cancer Research Center, Seattle, WA; and School of Pharmacy, and.
Rainer StorbDivision of Clinical Research, Fred Hutchinson Cancer Research Center, Seattle, WA; and Department of Medicine.
Paul A CarpenterDivision of Clinical Research, Fred Hutchinson Cancer Research Center, Seattle, WA; and Department of Pediatrics, University of Washington, Seattle, WA.
Mary E D FlowersDivision of Clinical Research, Fred Hutchinson Cancer Research Center, Seattle, WA; and Department of Medicine.
Frederick R AppelbaumDivision of Clinical Research, Fred Hutchinson Cancer Research Center, Seattle, WA; and Department of Medicine.
Paul J MartinDivision of Clinical Research, Fred Hutchinson Cancer Research Center, Seattle, WA; and Department of Medicine.

Funding

Translational Bioimaging Core Shared ResourceP30CA015704 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Marian Esvelt · 1985 to 2026
$296.4M
VIRUS-MEDIATED MYELOSUPPRESSIONP01CA018029 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Geoffrey Roger HILL · 1985 to 2026
$128.4M
Project 3: Stem Cell Allografts for Lymphoid MalignanciesP01CA078902 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI SANDMAIER, BRENDA MARIE · 1999 to 2025
$46.1M
Optimizing Busulfan: Efficacy, Toxicity, and PharmacometabolomicsR01CA182963 · NCI · UNIVERSITY OF WASHINGTON · PI MCCUNE, JEANNINE S · 2014 to 2018
$2.5M
Statins for Prevention of GVHDR01HL108307 · NHLBI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI MIELCAREK, MARCO B · 2011 to 2015
$2.2M
Pharmacogenetics of Cyclophosphamide ADRs inR21CA162059 · NCI · UNIVERSITY OF WASHINGTON · PI MCCUNE, JEANNINE S · 2011 to 2012
$660k
NCI NIH HHS CA015704NCI NIH HHS CA018029NCI NIH HHS CA078902NCI NIH HHS CA162059NCI NIH HHS CA182963NCI NIH HHS P01 CA018029NCI NIH HHS P01 CA078902NCI NIH HHS P30 CA015704NCI NIH HHS R01 CA182963NCI NIH HHS R21 CA162059NHLBI NIH HHS HL108307NHLBI NIH HHS R01 HL108307
6 · The paper itself

Abstract

The cumulative incidence of National Institutes of Health (NIH)-defined chronic graft-versus-host disease (GVHD) requiring systemic treatment is ∼35% at 1 year after transplantation of granulocyte colony-stimulating factor (G-CSF)-mobilized blood cells from HLA-matched related or unrelated donors. We hypothesized that high-dose cyclophosphamide given after G-CSF-mobilized blood cell transplantation would reduce the cumulative 1-year incidence of chronic GVHD to 15% or less. Forty-three patients with high-risk hematologic malignancies (median age, 43 years) were enrolled between December 2011 and September 2013. Twelve (28%) received grafts from related donors, and 31 (72%) received grafts from unrelated donors. Pretransplant conditioning consisted of fludarabine and targeted busulfan (n = 25) or total body irradiation (≥12 Gy; n = 18). Cyclophosphamide was given at 50 mg/kg per day on days 3 and 4 after transplantation, followed by cyclosporine starting on day 5. The cumulative 1-year incidence of NIH-defined chronic GVHD was 16% (95% confidence interval, 5-28%). The cumulative incidence estimates of grades 2-4 and 3-4 acute GVHD were 77% and 0%, respectively. At 2 years, the cumulative incidence estimates of nonrelapse mortality and recurrent malignancy were 14% and 17%, respectively, and overall survival was projected at 70%. Of the 42 patients followed for ≥1 year, 21 (50%) were relapse-free and alive without systemic immunosuppression at 1 year after transplantation. Thus, myeloablative pretransplant conditioning can be safely combined with high-dose cyclophosphamide after transplantation, and the risk of chronic GVHD associated with HLA-matched mobilized blood cell grafts can be substantially reduced. This trial was registered at www.clinicaltrials.gov as #NCT01427881.

Indexed as

AdolescentAdultAgedAllograftsBusulfanChildChild, PreschoolCyclophosphamideDisease-Free SurvivalFemaleGraft vs Host DiseaseHematologic NeoplasmsHematopoietic Stem Cell MobilizationHistocompatibilityHumansImmunosuppressive AgentsBusulfanCyclophosphamidefludarabineImmunosuppressive AgentsMyeloablative AgonistsVidarabine

Identifiers

PMID26764356
PMCPMC4797026

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.