Evidence map›Paper›PMID 39151112›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2024

A Multicenter Phase II Trial of Ruxolitinib for Treatment of Corticosteroid Refractory Sclerotic Chronic Graft-Versus-Host Disease.

Vijaya Raj Bhatt, Valerie K Shostrom, Hannah K Choe, Betty K Hamilton, Krishna Gundabolu, Lori J Maness, Virender Kumar, Ram I Mahato, Lynette M Smith, Taiga Nishihori and 1 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03616184 (A Single Arm, Open Label, Phase II Study of Ruxolitinib in Sclerotic Chronic Graft-Versus-Host Disease After Failure of Systemic Glucocorticoids), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–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.

NCT03616184 phase2completednot on this map

A Single Arm, Open Label, Phase II Study of Ruxolitinib in Sclerotic Chronic Graft-Versus-Host Disease After Failure of Systemic Glucocorticoids

TypeinterventionalSponsorUniversity of NebraskaRan2018 to 2023Enrolled49ConditionsGraft-versus-host-disease (GVHD)ArmsRuxolitinib
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. 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

11 authors.

Vijaya Raj BhattDivision of Hematology-Oncology, Department of Internal Medicine, University of Nebraska Medical Center, Omaha, NE.ORCID 0000-0003-2513-0533
Valerie K ShostromDepartment of Biostatistics, University of Nebraska Medical Center, Omaha, NE.
Hannah K ChoeDivision of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, OH.ORCID 0000-0002-2849-2989
Betty K HamiltonBlood and Marrow Transplant Program, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH.ORCID 0000-0003-1252-6539
Krishna GundaboluDivision of Hematology-Oncology, Department of Internal Medicine, University of Nebraska Medical Center, Omaha, NE.ORCID 0000-0003-4206-7468
Lori J ManessDivision of Hematology-Oncology, Department of Internal Medicine, University of Nebraska Medical Center, Omaha, NE.
Virender KumarDepartment of Pharmaceutical Sciences, University of Nebraska Medical Center, Omaha, NE.
Ram I MahatoDepartment of Pharmaceutical Sciences, University of Nebraska Medical Center, Omaha, NE.
Lynette M SmithDepartment of Biostatistics, University of Nebraska Medical Center, Omaha, NE.ORCID 0000-0002-0836-9932
Taiga NishihoriDepartment of Blood and Marrow Transplant and Cellular Immunotherapy, Moffitt Cancer Center, Tampa, FL.ORCID 0000-0002-2621-7924
Stephanie J LeeClinical Research Division, Fred Hutchinson Cancer Center and Department of Medicine, University of Washington, Seattle, WA.ORCID 0000-0003-2600-6390

Funding

UNMC/EPPLEY CANCER CENTER SUPPORT GRANTP30CA036727 · NCI · UNIVERSITY OF NEBRASKA MEDICAL CENTER · PI Amy M Overby · 1985 to 2026
$55.0M
Tracking and Evaluation CoreU54GM115458 · NIGMS · UNIVERSITY OF NEBRASKA MEDICAL CENTER · PI GUDA, CHITTIBABU · 2016 to 2025
$42.8M
Targeting PI3K/BRD4 and Hedgehog Pathway in Alcohol Associated Liver DiseaseK01AA029763 · NIAAA · UNIVERSITY OF TOLEDO HEALTH SCI CAMPUS · PI KUMAR, VIRENDER · 2021 to 2025
$528k
NCI NIH HHS P30 CA036727NIAAA NIH HHS K01 AA029763NIGMS NIH HHS U54 GM115458
6 · The paper itself

Abstract

purposeSclerotic chronic graft-versus-host disease (cGVHD) represents a highly morbid and refractory form of cGVHD, and novel therapies for sclerotic cGVHD are critically needed. This study aimed to determine the efficacy of ruxolitinib in patients with corticosteroid refractory sclerotic cGVHD. PATIENTS AND

methodsIn a single-arm multicenter phase II trial (N = 47), adults with sclerotic cGVHD refractory to corticosteroids and ≥one additional line of systemic therapy for cGVHD received ruxolitinib for ≥six months (ClinicalTrials.gov identifier: NCT03616184). The primary end point was complete or partial response (PR) in skin and/or joint defined according to the 2014 National Institute of Health cGVHD Consensus Criteria.

resultsFollowing the use of ruxolitinib for a median of 11 months, PR in skin and/or joints was noted in 49% (95% CI, 34 to 64) at 6 months, with 45% having joint and fascia response and 19% having skin response. The duration of skin/joint response was 77% (95% CI, 48 to 91) at 12 months. Overall cGVHD PR was noted in 47% (95% CI, 32 to 61). Improvement in Lee Symptom Scale summary and skin subscale scores was noted in 38% of patients. With a cumulative incidence of treatment failure of 20.8% (95% CI, 10.0 to 34.1), nonrelapse mortality (NRM) of 2.2% (95% CI, 0.17 to 10.3), and no recurrent malignancy, failure-free survival (FFS) was 77.1% (95% CI, 61.3 to 87.0) at 12 months. Ruxolitinib was overall well tolerated with no new safety signals.

conclusionThe use of ruxolitinib was associated with relatively high rates of skin/joint responses and overall cGVHD responses, improvement in patient-reported outcomes, low NRM, and high FFS in patients with refractory sclerotic cGVHD. Ruxolitinib offers an effective treatment option for refractory sclerotic cGVHD.

Indexed as

Adrenal Cortex HormonesGraft vs Host DiseaseNitrilesPyrazolesPyrimidinesSclerosisAdultAgedChronic DiseaseFemaleHumansMaleMiddle AgedYoung AdultAdrenal Cortex HormonesNitrilesPyrazolesPyrimidinesruxolitinib

Identifiers

PMID39151112
PMCPMC11568950

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.