Study of Belumosudil and Prednisone for Patients Aged 12 and Older with Newly Diagnosed Chronic Graft Versus Host Disease

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What is this study about?

This clinical trial is focused on studying a condition called chronic graft versus host disease (cGVHD). This condition can occur after a person receives a stem cell or bone marrow transplant, where the donated cells attack the recipient’s body. The study is testing a new oral medication called belumosudil, which is being used in combination with corticosteroids, a type of medication that helps reduce inflammation and suppress the immune system. The trial will compare the effects of belumosudil combined with corticosteroids against a placebo combined with corticosteroids.

The purpose of the study is to see if belumosudil, when used with corticosteroids, is more effective than corticosteroids alone in improving the condition of patients with newly diagnosed cGVHD. Participants in the study will be randomly assigned to receive either the combination of belumosudil and corticosteroids or a placebo and corticosteroids. The study will monitor participants over a period to assess their health and any changes in their condition.

Throughout the study, participants will take the medication orally, and their progress will be closely observed by the research team. The trial aims to provide valuable information on the safety and effectiveness of belumosudil in treating cGVHD, potentially offering a new treatment option for those affected by this condition.

1 joining the study

Upon joining the study, participants must be at least 12 years old and have a newly diagnosed condition known as chronic graft versus host disease (cGVHD).

Participants must require treatment with corticosteroids and should not have received any prior systemic treatment for cGVHD.

2 randomization

Participants are randomly assigned to receive either the study medication, belumosudil, in combination with prednisone, or a placebo in combination with prednisone.

This process is double-blind, meaning neither the participants nor the researchers know who receives the study medication or the placebo.

3 medication administration

Participants take the study medication or placebo orally. The specific dosage and frequency are determined by the study protocol.

The treatment continues for a specified duration, which is determined by the study’s design and objectives.

4 monitoring and assessments

Participants undergo regular monitoring to assess the effectiveness and safety of the treatment.

Assessments include measuring event-free survival, which is the time from randomization to the occurrence of any predefined event.

5 completion of the study

The study is estimated to conclude by September 29, 2028.

Participants’ health and response to the treatment are evaluated to determine the study’s outcomes.

Who Can Join the Study?

  • Patients must be at least 12 years old at the time of signing the informed consent.
  • Participants should have had a type of stem cell transplant called allogenic HCT and have newly diagnosed moderate to severe chronic graft versus host disease (cGVHD) as per specific guidelines from 2014.
  • Participants need to require treatment with a type of medication called corticosteroids for their cGVHD.
  • Participants should not have received any previous treatment that affects the whole body for cGVHD, including a treatment known as ECP (extracorporeal photopheresis).
  • If participants are taking other medications that suppress the immune system to prevent or treat a different condition called acute GVHD, the dose should be below a certain level specified in the study protocol.
  • Participants must weigh at least 40 kilograms.
  • Men and women participating in the study should use birth control methods that comply with local rules for clinical studies.
  • Participants or their legally authorized representative must be able to provide signed informed consent, which means they agree to take part in the study after understanding what it involves.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Centre hospitalier universitaire de Liege Liege Belgium
Universitair Ziekenhuis Gent Gent Belgium
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
St. Anna Kinderspital GmbH Vienna Austria
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Institute Of Hematology And Blood Transfusion Prague Czechia
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital De Santa Maria E.P.E. Lisbon Portugal
Hospital Santa Maria Della Misericordia Perugia Italy
Algemeen Ziekenhuis Delta Roeselare Belgium
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki Greece
Uniwersytecki Szpital Dzieciecy W Krakowie Cracow Poland
Grande Ospedale Metropolitano Bianchi Melacrino Morelli Reggio Calabria Italy
Virgen del Rocío University Hospital Sevilla Spain
Odense University Hospital Odense Denmark
Universitaetsklinikum Regensburg AöR Regensburg Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Ospedale San Raffaele S.r.l. Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Region Skane Skanes Universitetssjukhus Lund Sweden
Hospital Clinic De Barcelona Barcelona Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Fakultni Nemocnice Brno Brno Czechia
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Karolinska University Hospital Solna Sweden
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
IRCCS Ospedale Policlinico San Martino Genoa Italy
Universita’ Politecnica Delle Marche Ancona Italy
Prinses Maxima Centrum voor Kinderoncologie B.V. Utrecht The Netherlands
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Rennes Rennes France
Rigshospitalet Copenhagen Denmark
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
University Hospital Ostrava Ostrava Czechia
Cyodetizy Ukltqhcgdhvchk Sgnretxly Woluwe-Saint-Lambert Belgium
Uzwtjvfffh Myyvung Cphgzm Hxgvismbudgzkmnmb Hamburg Germany
Amwipbe Ouutqllyppz Pvjt Gvpctpuu Xgajp Bergamo Italy
Ojddrynzlwaini Llot Gags Linz Austria
Ukhkrdanggdx Mkowvep Ccszxon Gopzvjwmb Groningen The Netherlands
Hohzslqt Uwkletwcqblnj Mzrjaxp Dt Vbhnvmhbrf Santander Spain
Ixaqxlbu Clmuim Djztmazlrwyvguujr L'hospitalet De Llobregat Spain
Uyxcosbuye Hxgjxrmt Cbkpwmu Cologne Germany
Awttqkcjd Uvu Amsterdam The Netherlands
Eqwvnle Ucoixwecnixk Mhewjvq Cqttqpe Rrctgjrlg (diuriwh Mhr Rotterdam The Netherlands
Aaowba Uafbaotshx Hvaavjgn Aarhus Denmark
Aorjtyx Oqsoppxxdkg Umjuktanfjmyh Carcowfkobfz Drcuq Savaui E Djhwk Sdseurx Du Ttzrwj Turin Italy
Uhwiicqzsaoejeuvgmvzp Mgklcegs Ayz Munster Germany
Chtl De Nojbs Vandoeuvre Les Nancy France
Nozsksob Impiibni Onmgpminh Iyu Mtgax Sfaywmzbbguxranwrvdxandenyoq Itwpeumb Blncrjnh Cracow Poland
Atcvdvj Uvbok Saxhcvqls Lgylyu De Bnpcwhd Bologna Italy
Ulhuefmqjpfpoj Csomhxv Kdaqjvaeo Gdansk Poland
Izgtqkul Phskuckqssswonc Cyzeby Cevjnr Marseille France
Sfzxnrhgqtz Pdktwcpiv Sqfrnor Kioyhuqbx Iskrergywqc Mycjeznjvaw Spj W Kwecctbulw Katowice Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
22.02.2024
Belgium Belgium
Not recruiting
22.02.2024
Czechia Czechia
Not recruiting
22.02.2024
Denmark Denmark
Not recruiting
22.02.2024
France France
Not recruiting
22.02.2024
Germany Germany
Not recruiting
22.02.2024
Greece Greece
Not recruiting
22.02.2024
Italy Italy
Not recruiting
22.02.2024
Poland Poland
Not recruiting
22.02.2024
Portugal Portugal
Not recruiting
22.02.2024
Spain Spain
Not recruiting
22.02.2024
Sweden Sweden
Not recruiting
22.02.2024
The Netherlands The Netherlands
Not recruiting
22.02.2024

Trial locations

Belumosudil is a medication being studied for its potential to help people with chronic graft versus host disease (cGVHD). It is being tested to see if it can improve the condition when used together with corticosteroids, which are commonly used to reduce inflammation and suppress the immune system.

Prednisone is a type of corticosteroid used in this study. It is a medication that helps reduce inflammation and suppress the immune system, which can be beneficial in managing chronic graft versus host disease (cGVHD). The study is comparing the effects of prednisone alone to prednisone used in combination with belumosudil.

Chronic Graft Versus Host Disease – This condition occurs when donor cells from a transplant attack the recipient’s body. It typically develops after a bone marrow or stem cell transplant. The disease can affect various organs, including the skin, liver, and digestive tract. Symptoms may include skin rashes, dry eyes, and mouth, as well as liver dysfunction. Over time, it can lead to scarring and damage to the affected organs. The progression and severity can vary widely among individuals.

Trial ID:
2023-505394-32-00
Protocol code:
EFC17757
NCT ID:
NCT06143891
Trial Phase:
Therapeutic confirmatory (Phase III)

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