Evidence map›Paper›PMID 24607553›Full record

Trial reportBiology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation2014

Randomized, double-blind, placebo-controlled trial of soluble tumor necrosis factor receptor: enbrel (etanercept) for the treatment of idiopathic pneumonia syndrome after allogeneic stem cell transplantation: blood and marrow transplant clinical trials network protocol.

Gregory A Yanik, Mary M Horowitz, Daniel J Weisdorf, Brent R Logan, Vincent T Ho, Robert J Soiffer, Shelly L Carter, Juan Wu, John R Wingard, Nancy L Difronzo and 6 more

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00421174 (A Randomized Double-Blind, Placebo-Controlled Trial of Soluble Tumor Necrosis Factor Receptor), which is not on this map. Cited by 37 papers.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed
7.5field-weighted citation impact, top 2% 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.

NCT00421174 phase3completednot on this map

A Randomized Double-Blind, Placebo-Controlled Trial of Soluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Acute Idiopathic Pneumonia Syndrome Following Allogeneic Cell Transplantation (BMTCTN0403)

TypeinterventionalSponsorNational Heart, Lung, and Blood Institute (NHLBI)Ran2007 to 2013Enrolled37ConditionsPneumonia, Idiopathic Pneumonia SyndromeArmsEtanercept, Placebo plus corticosteroid
3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 91 citations in OpenAlex.

  1. Trial
  2. Trial
  3. CALIPSO: A Randomized Controlled Trial of Calfactant for Acute Lung Injury in Pediatric Stem Cell and Oncology Patients.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2018
    Trial
  4. Diagnostic and Prognostic Plasma Biomarkers for Idiopathic Pneumonia Syndrome after Hematopoietic Cell Transplantation.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2018
    Trial
  5. Trial
  6. Fluticasone, Azithromycin, and Montelukast Treatment for New-Onset Bronchiolitis Obliterans Syndrome after Hematopoietic Cell Transplantation.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2016
    Trial
  7. Trial
  8. Review
  9. Article
  10. Article
  11. Article
  12. Article
  13. Review
  14. Noninfectious complications of hematopoietic cell transplantation.Hematology. American Society of Hematology. Education Program · 2021
    Article
  15. Article
  16. Review
  17. Article
  18. Review
  19. 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

16 authors at 11 institutions in 1 country.

Gregory A YanikDepartment of Pediatrics and Internal Medicine, Blood and Marrow Transplant Program, University of Michigan Medical Center, Ann Arbor, Michigan. Electronic address: gyanik@umich.edu.
Mary M HorowitzCenter for International Blood and Marrow Transplant Research, Medical College of Wisconsin, Milwaukee, Wisconsin.
Daniel J WeisdorfDepartment of Internal Medicine, University of Minnesota Blood and Marrow Transplantation Program, Minneapolis, Minnesota.
Brent R LoganCenter for International Blood and Marrow Transplant Research, Medical College of Wisconsin, Milwaukee, Wisconsin.
Vincent T HoDepartment of Hematologic Malignancies, Dana Farber Cancer Institute, Boston, Massachusetts.
Robert J SoifferDepartment of Hematologic Malignancies, Dana Farber Cancer Institute, Boston, Massachusetts.
Shelly L CarterThe EMMES Corporation, Rockville, Maryland.
Juan WuThe EMMES Corporation, Rockville, Maryland.
John R WingardDepartment of Medicine, University of Florida, Gainesville, Florida.
Nancy L DifronzoDivision of Blood Diseases and Resources, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.
James L FerraraDepartment of Pediatrics and Internal Medicine, Blood and Marrow Transplant Program, University of Michigan Medical Center, Ann Arbor, Michigan.
Sergio GiraltDepartment of Stem Cell Transplantation, Memorial Sloan Kettering Cancer Center, New York, New York.
David K MadtesClinical Research Division, Fred Hutchinson Cancer Research Center and Division of Pulmonary and Critical Care Medicine, University of Washington, Seattle, Washington.
Rebecca DrexlerNational Marrow Donor Program, Minneapolis, Minnesota; Center for International Blood and Marrow Transplant Research, Minneapolis, Minnesota.
Eric S WhiteDepartment of Internal Medicine, Pulmonary and Critical Care Medicine, University of Michigan Medical Center, Ann Arbor, Michigan.
Kenneth R CookeDepartment of Oncology, Sidney Kimmel Cancer Center, Johns Hopkins University, School of Medicine, Baltimore, Maryland.
University of Michigan · USDana-Farber Cancer Institute · USEmmes (United States) · USMedical College of Wisconsin · USJohns Hopkins University · USMemorial Sloan Kettering Cancer Center · USNational Institutes of Health · USNational Marrow Donor Program · USUniversity of Florida · USUniversity of Minnesota · USUniversity of Washington · US

Funding

Data Resource for Analyzing Blood &Marrow TransplantsU24CA076518 · NCI · MEDICAL COLLEGE OF WISCONSIN · PI Amy M Moskop, Bronwen Shaw · 1998 to 2026
$105.2M
Easy-to-read Informed Consent for HCT Clinical TrialsU10HL069294 · NHLBI · MEDICAL COLLEGE OF WISCONSIN · PI HOROWITZ, MARY MARESCA · 2011 to 2016
$43.8M
Hutchinson Center as Lead Academic Participating Site (U10)U10CA180828 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI APPELBAUM, FREDERICK · 2014 to 2018
$3.0M
BMT CTN Core- University of Pennsylvania Abramson Cancer CenterUG1HL069286 · NHLBI · UNIVERSITY OF PENNSYLVANIA · PI Edward A Stadtmauer · 2017 to 2026
$2.0M
University of Michigan Core Clinical Center for the BMT Research NetworkUG1HL069330 · NHLBI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI SUNG WON CHOI, Mary Mansour Riwes · 2017 to 2026
$1.8M
MSKCC BMT CTN Renewal U10HL069315 · NHLBI · SLOAN-KETTERING INST CAN RESEARCH · PI GIRALT, SERGIO A · 2011 to 2016
$1.1M
Blood & Marrow Clinical Trials Network - Hutchinson Center Core Clinical SitU10HL069246 · NHLBI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI APPELBAUM, FREDERICK · 2011 to 2016
$1.1M
A Randomized Trial of Tac/MTX/bortezomib vs Tac/MTXplacebo in Allogeneic HSCTU10HL069249 · NHLBI · DANA-FARBER CANCER INST · PI ANTIN, JOSEPH H · 2011 to 2016
$1.1M
Bone Marrow Transplant Clinical NetworkU10HL069286 · NHLBI · UNIVERSITY OF PENNSYLVANIA · PI STADTMAUER, EDWARD A · 2011 to 2016
$986k
University of Michigan Core Clinical Center for BMT Research NetworkU10HL069330 · NHLBI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI YANIK, GREGORY A · 2011 to 2016
$959k
Enhancing the Safety of Allogeneic TransplantationU10HL069290 · NHLBI · UNIVERSITY OF MINNESOTA · PI WEISDORF, DANIEL J · 2011 to 2016
$931k
Case BMT CTN: Antibacterial Prophylaxis in Post-Engraftment Allogeneic HCTU10HL069348 · NHLBI · CASE WESTERN RESERVE UNIVERSITY · PI DE LIMA, MARCOS · 2011 to 2016
$902k
NCI NIH HHS U10 CA180828NCI NIH HHS U24 CA076518NHLBI NIH HHS U10 HL069246NHLBI NIH HHS U10 HL069249NHLBI NIH HHS U10 HL069286NHLBI NIH HHS U10 HL069290NHLBI NIH HHS U10 HL069294NHLBI NIH HHS U10HL069294NHLBI NIH HHS U10 HL069301NHLBI NIH HHS U10 HL069315NHLBI NIH HHS U10 HL069330NHLBI NIH HHS U10 HL069348NHLBI NIH HHS UG1 HL069286NHLBI NIH HHS UG1 HL069330
6 · The paper itself

Abstract

Idiopathic pneumonia syndrome (IPS) is a diffuse, noninfectious lung injury that occurs acutely after allogeneic hematopoietic cell transplantation (HCT). IPS-related mortality has been historically high (>50%) despite treatment with systemic corticosteroids and supportive care measures. We have now examined the role of tumor necrosis factor inhibition in a randomized, double-blind, placebo-controlled trial of corticosteroids with etanercept or placebo. Thirty-four subjects (≥18 years) with IPS after HCT were randomized to receive methylprednisolone (2 mg/kg/day) plus etanercept (0.4 mg/kg twice weekly × 4 weeks; n = 16) or placebo (n = 18). No active infections and a pathogen-negative bronchoscopy were required at study entry. Response (alive, with complete discontinuation of supplemental oxygen support) and overall survival were examined. This study, originally planned to accrue 120 patients, was terminated prematurely due to slow accrual. In the limited number of patients examined, there were no differences in response rates at day 28 of study. Ten of 16 patients (62.5% [95% confidence interval {CI}, 35.4% to 84.8%]) receiving etanercept and 12 of 18 patients (66.7% [95% CI, 41.0% to 86.7%]) receiving placebo met the day 28 response definition (P = 1.00). The median survival was 170 days (95% CI, 11 to 362) with etanercept versus 64 days (95% CI, 26 to 209) with placebo (P = .51). Among responders, the median time to discontinuation of supplemental oxygen was 9 days (etanercept) versus 7 days (placebo). Therapy was well tolerated, with 1 toxicity-related death from infectious pneumonia in the placebo arm. The treatment of IPS with corticosteroids in adult HCT recipients was associated with high early response rates (>60%) compared with historical reports, with poor overall survival. The addition of etanercept did not lead to further increases in response, although the sample size of this truncated trial preclude a definitive conclusion.

Indexed as

Adrenal Cortex HormonesAdultAgedDouble-Blind MethodEtanerceptFemaleHematopoietic Stem Cell TransplantationHumansIdiopathic Interstitial PneumoniasImmunoglobulin GMaleMiddle AgedReceptors, Tumor Necrosis FactorTransplantation, HomologousTreatment OutcomeYoung AdultAdrenal Cortex HormonesEtanerceptImmunoglobulin GReceptors, Tumor Necrosis FactorBone marrow transplantationIPSPneumoniaPulmonaryTNF

Identifiers

PMID24607553
PMCPMC4128626
OpenAlexW2052170132

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.