Evidence map›Paper›PMID 31332045›Full record

Trial reportBlood advances2019

Randomized controlled study of ECP with methoxsalen as first-line treatment of patients with moderate to severe cGVHD.

Madan Jagasia, Christof Scheid, Gérard Socié, Francis Ayuketang Ayuk, Johanna Tischer, Michele L Donato, Árpád Bátai, Heidi Chen, Sheau-Chiann Chen, Thomas Chin and 3 more

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

Trial report in Blood advances, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01380535 (A Randomized Controlled Study of Extracorporeal Photopheresis), which is not on this map. Cited by 19 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 2 pooled it
4.4field-weighted citation impact, top 5% 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.

NCT01380535 early_phase1completednot on this map

A Randomized Controlled Study of Extracorporeal Photopheresis (ECP) Therapy With UVADEX for the Treatment of Patients With Moderate to Severe Chronic Graft-versus-Host Disease (cGvHD)

TypeinterventionalSponsorMallinckrodtRan2011 to 2015Enrolled60ConditionsChronic Graft Versus Host DiseaseArmsECP Methoxsalen, Standard of Care
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 2 syntheses or guidelines pooled it, 53 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Observational
  4. Review
  5. Review
  6. Article
  7. Review
  8. Article
  9. Review
  10. Article
  11. Review
  12. Article
  13. Article
  14. Article
  15. Article
  16. European dermatology forum - updated guidelines on the use of extracorporeal photopheresis 2020 - part 1.Journal of the European Academy of Dermatology and Venereology : JEADV · 2020
    Article
  17. Extracorporeal Photopheresis in Graft-versus-Host Disease.Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie · 2020
    Review
  18. Review
  19. 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

13 authors at 9 institutions in 4 countries.

Madan JagasiaVanderbilt-Ingram Cancer Center, Nashville, TN.
Christof ScheidStem Cell Transplantation Clinic I for Internal Medicine, University of Cologne, Köln, Germany.
Gérard SociéAPHP Hospital St. Louis, University Paris 7, Paris, France.ORCID 0000-0002-2114-7533
Francis Ayuketang AyukDepartment of Stem Cell Transplantation, Universitäetsklinikum Hamburg-Eppendorf, Hamburg, Germany.
Johanna TischerDepartment of Internal Medicine III, University Hospital of Munich, Ludwig Maximilian University, Munich, Germany.
Michele L DonatoJohn Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ.
Árpád BátaiUnified St. Istvan and St. Laszio Hospital, Budapest, Hungary.
Heidi ChenVanderbilt University Medical Center, Nashville, TN.
Sheau-Chiann ChenVanderbilt University Medical Center, Nashville, TN.ORCID 0000-0002-5574-1434
Thomas ChinMallinckrodt Pharmaceuticals, Bedminster, NJ; and.
Henri BoodéeMallinckrodt Pharmaceuticals, Bedminster, NJ; and.
Ghaith MitriMallinckrodt Pharmaceuticals, Bedminster, NJ; and.ORCID 0000-0002-0077-7464
Hildegard T GreinixDivision of Haematology, Medical University of Graz, Graz, Austria.
Mallinckrodt (United States) · USVanderbilt University Medical Center · USHackensack University Medical Center · USLudwig-Maximilians-Universität München · DEMedical University of Graz · ATUniversität Hamburg · DEUniversité Paris Cité · FRUniversity of Cologne · DEVanderbilt University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The investigation of extracorporeal photopheresis (ECP) plus standard of care (SoC) (SoC+ECP) in chronic graft-versus-host disease (cGVHD) within prospective, randomized clinical studies is limited, despite its frequent clinical use. This phase 1/pilot study was the first randomized, prospective study to investigate ECP use as first-line therapy in cGVHD, based on the 2015 National Institutes of Health (NIH) consensus criteria for diagnosis and response assessment. Adult patients with new-onset (≤3 years of hematopoietic stem cell transplantation) moderate or severe cGVHD were randomized 1:1 to 26 weeks of SoC+ECP vs SoC (corticosteroids and cyclosporine A/tacrolimus) between 2011 and 2015. The primary endpoint was overall response rate (ORR), defined as complete or partial response, at week 28 in the intention-to-treat population (ITT). Other outcomes included quality of life (QoL) measures and safety. Sixty patients were randomized; ITT included 53 patients (SoC+ECP: 29; SoC: 24). Week 28 ORR was 74.1% (SoC+ECP) and 60.9% (SoC). Investigator-assessed ORR was 56.0% (SoC+ECP) and 66.7% (SoC). Patients treated with SoC experienced a decline in QoL over the 28-week study period; QoL remained unchanged in SoC+ECP patients. Most frequent treatment-emergent adverse events (TEAEs) in SoC+ECP patients were hypertension (31.0%), cough (20.7%), dyspnea (17.2%), and fatigue (17.2%). Seventeen patients (SoC+ECP: 8; SoC: 9) experienced 35 serious adverse events (SAEs). No TEAEs or SAEs were considered related to the ECP instrument or methoxsalen. The encouraging short-term results of this study could inform the design of subsequent studies. This trial was registered at www.clinicaltrials.gov as #NCT01380535.

Indexed as

PhotopheresisAdultAgedFemaleGraft vs Host DiseaseHematopoietic Stem Cell TransplantationHumansMaleMethoxsalenMiddle AgedQuality of LifeSeverity of Illness IndexTreatment OutcomeYoung AdultMethoxsalen

Identifiers

PMID31332045
PMCPMC6650730
OpenAlexW2963935879

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.