Evidence map›Paper›PMID 34265047›Full record

Trial reportBlood2021

Belumosudil for chronic graft-versus-host disease after 2 or more prior lines of therapy: the ROCKstar Study.

Corey Cutler, Stephanie J Lee, Sally Arai, Marcello Rotta, Behyar Zoghi, Aleksandr Lazaryan, Aravind Ramakrishnan, Zachariah DeFilipp, Amandeep Salhotra, Wanxing Chai-Ho and 29 more

Erratum issued 2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Blood, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 197 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
197citing papers in PubMed, 4 pooled it
27.3field-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.

NCT03640481 phase2terminatednot on this map

A Phase 2, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of KD025 in Subjects With Chronic Graft Versus Host Disease (cGVHD) After At Least 2 Prior Lines of Systemic Therapy (The ROCKstar Study)

TypeinterventionalSponsorKadmon, a Sanofi CompanyRan2018 to 2023Enrolled159ConditionsChronic Graft-versus-host-diseaseArmsBelumosudil (KD025)
NCT06046248 phase2recruitingnot on this mapstarted 2024, after this paper: background citation

Phase II Trial of Belumosudil and Rituximab for the Primary Treatment of Extensive Chronic Graft-versus-host Disease

TypeinterventionalSponsorNorthside Hospital, Inc.Ran2024 to 2027Enrolled25ConditionsChronic Graft Versus Host DiseaseArmsBelumosudil, Rituximab
3 · Its place in the literature

Who cites it

197 citing papers in PubMed, 4 syntheses or guidelines pooled it, 304 citations in OpenAlex.

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  15. Axatilimab for Chronic Graft-Versus-Host Disease After Failure of at Least Two Prior Systemic Therapies: Results of a Phase I/II Study.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023
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137 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

39 authors at 20 institutions in 1 country.

Corey CutlerDivision of Transplantation and Cellular Therapy, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.
Stephanie J LeeFred Hutchinson Cancer Research Center, Seattle, WA.ORCID 0000-0003-2600-6390
Sally AraiStanford University Medical Center, Stanford, CA.ORCID 0000-0003-1993-4172
Marcello RottaColorado Blood Cancer Institute, Denver, CO.
Behyar ZoghiTexas Transplant Institute, Methodist Hospital, San Antonio, TX.
Aleksandr LazaryanMoffitt Cancer Center, Tampa, FL.ORCID 0000-0001-9605-6436
Aravind RamakrishnanSt David's South Austin Medical Center, Austin, TX.
Zachariah DeFilippMassachusetts General Hospital, Boston, MA.ORCID 0000-0002-7994-8974
Amandeep SalhotraCity of Hope Medical Center, Duarte, CA.
Wanxing Chai-HoUniversity of California, Los Angeles Medical Center, Los Angeles, CA.
Rohtesh MehtaMD Anderson Cancer Center, Houston, TX.
Trent WangUniversity of Miami, Miami, FL.
Mukta AroraUniversity of Minnesota Masonic Cancer Center, Minneapolis, MN.ORCID 0000-0001-9362-0556
Iskra PusicWashington University School of Medicine, Saint Louis, MO.
Ayman SaadThe Ohio State University Wexner Medical Center, Columbus, OH.ORCID 0000-0003-0003-0130
Nirav N ShahFroedtert Hospital and the Medical College of Wisconsin, Milwaukee, WI.
Sunil AbhyankarThe University of Kansas Cancer Center, Fairway, KS.
Carlos BachierSarah Cannon Research Institute, Nashville, TN.
John GalvinUniversity of Illinois at Chicago, Chicago, IL.ORCID 0000-0001-8722-0230
Annie ImUniversity of Pittsburgh Medical Center-Hillman Cancer Center, Pittsburgh, PA.
Amelia LangstonWinship Cancer Institute of Emory University, Atlanta, GA.ORCID 0000-0003-0649-1915
Jane LiesveldUniversity of Rochester, Rochester, NY.
Mark JuckettUniversity of Wisconsin Carbone Cancer Center, Madison, WI.ORCID 0000-0003-2074-5678
Aaron LoganHelen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco, CA.
Levanto SchachterOregon Health and Science University, Portland, OR.
Asif AlaviBarbara Ann Karmanos Cancer Institute, Detroit, MI.
Dianna HowardBaptist Medical Center, Wake Forest University School of Medicine, Winston-Salem, NC.
Harlan W WaksalKadmon Corporation, New York, NY.
John RyanKadmon Corporation, New York, NY.
David EiznhamerKadmon Corporation, New York, NY.
Sanjay K AggarwalKadmon Corporation, New York, NY.
Jonathan IeyoubKadmon Corporation, New York, NY.
Olivier SchuellerKadmon Corporation, New York, NY.
Laurie GreenKadmon Corporation, New York, NY.
Zhongming YangKadmon Corporation, New York, NY.
Heidi KrenzKadmon Corporation, New York, NY.
Madan JagasiaVanderbilt-Ingram Cancer Center, Nashville, TN.
Bruce R BlazarUniversity of Minnesota, Minneapolis, MN; and.ORCID 0000-0002-9608-9841
Steven PavleticCenter for Cancer Research, National Cancer Institute, Bethesda, MD.
Eon Corporation (United States) · USUniversity of Minnesota · USAtrium Health Wake Forest Baptist · USCity Of Hope National Medical Center · USColorado Blood Cancer Institute · USDana-Farber Cancer Institute · USEmory University · USFred Hutch Cancer Center · USFroedtert Hospital · USHouston Methodist · USMassachusetts General Hospital · USMoffitt Cancer Center · USNational Cancer Institute · USOregon Health & Science University · USSarah Cannon · USStanford Medicine · USSt David's Medical Center · USThe Barbara Ann Karmanos Cancer Institute · USThe Ohio State University Wexner Medical Center · USThe University of Kansas Cancer Center · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Fabien Delerue · 1985 to 2026
$290.8M
Project 3: Humoral Targets and B Cell Biology in Chronic Graft-vs.-Host DiseaseP01CA142106 · NCI · DANA-FARBER CANCER INST · PI RITZ, JEROME · 2009 to 2019
$17.5M
Single Cell Analysis and ImmunogeneticsP01HL158505 · NHLBI · DANA-FARBER CANCER INST · PI Corey S Cutler · 2022 to 2026
$15.3M
NIH Chronic GVHD Study GroupZIABC011743 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI PAVLETIC, STEVEN · 2016 to 2025
$10.2M
Enhancing Treg Therapeutic Efficacy in GVHDR01HL118979 · NHLBI · UNIVERSITY OF MINNESOTA · PI BLAZAR, BRUCE R, HIPPEN, KELI L · 2014 to 2025
$6.7M
Nongenotoxic conditioning for gene therapy and allogeneic transplantation in Fanconi anemiaR01HL147324 · NHLBI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Bruce R Blazar, HANS-PETER KIEM · 2020 to 2026
$4.1M
NCI NIH HHS P01 CA142106NCI NIH HHS P30 CA016672NHLBI NIH HHS P01 HL158505NHLBI NIH HHS R01 HL118979NHLBI NIH HHS R01 HL147324
6 · The paper itself

Abstract

Belumosudil, an investigational oral selective inhibitor of Rho-associated coiled-coil-containing protein kinase 2 (ROCK2), reduces type 17 and follicular T helper cells via downregulation of STAT3 and enhances regulatory T cells via upregulation of STAT5. Belumosudil may effectively treat patients with chronic graft-versus-host disease (cGVHD), a major cause of morbidity and late nonrelapse mortality after an allogeneic hematopoietic cell transplant. This phase 2 randomized multicenter registration study evaluated belumosudil 200 mg daily (n = 66) and 200 mg twice daily (n = 66) in subjects with cGVHD who had received 2 to 5 prior lines of therapy. The primary end point was best overall response rate (ORR). Duration of response (DOR), changes in Lee Symptom Scale score, failure-free survival, corticosteroid dose reductions, and overall survival were also evaluated. Overall median follow-up was 14 months. The best ORR for belumosudil 200 mg daily and 200 mg twice daily was 74% (95% confidence interval [CI], 62-84) and 77% (95% CI, 65-87), respectively, with high response rates observed in all subgroups. All affected organs demonstrated complete responses. The median DOR was 54 weeks; 44% of subjects have remained on therapy for ≥1 year. Symptom reduction with belumosudil 200 mg daily and 200 mg twice daily was reported in 59% and 62% of subjects, respectively. Adverse events (AEs) were consistent with those expected in patients with cGVHD receiving corticosteroids and other immunosuppressants. Sixteen subjects (12%) discontinued belumosudil because of possible drug-related AEs. Belumosudil, a promising therapy for cGVHD, was well tolerated with clinically meaningful responses. This trial was registered at www.clinicaltrials.gov as #NCT03640481.

Indexed as

AcetamidesAdultAgedFemaleGraft vs Host DiseaseHumansMaleMiddle AgedProtein Kinase Inhibitorsrho-Associated KinasesTreatment OutcomeYoung AdultAcetamidesbelumosudilProtein Kinase Inhibitorsrho-Associated KinasesROCK2 protein, human

Identifiers

PMID34265047
PMCPMC8641099
OpenAlexW3095621154

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.