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RECRUITING
NCT06388564
PHASE2

A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease

Sponsor: Incyte Corporation

View on ClinicalTrials.gov

Summary

This study will be conducted to determine the preliminary efficacy of axatilimab in combination with ruxolitinib and to assess the contribution of axatilimab to the combination treatment effect in participants with cGVHD.

Official title: A Phase 2, Open-Label, Randomized, Multicenter Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2024-10-11

Completion Date

2029-12-01

Last Updated

2026-03-23

Healthy Volunteers

No

Interventions

DRUG

Axatilimab

Axatilimab will be administered at protocol defined dose.

DRUG

Ruxolitinib

Ruxolitinib will be administered at protocol defined dose.

DRUG

Corticosteroids

Corticosteroids will be administered at protocol defined dose.

Locations (70)

Mayo Clinic Hospital

Phoenix, Arizona, United States

City of Hope Medical Center

Duarte, California, United States

University of California-Los Angeles Medl Cntr-Oncology Center Bowyer Clinic

Los Angeles, California, United States

Stanford Cancer Center

Stanford, California, United States

University of Colorado Cancer Center

Aurora, Colorado, United States

Colorado Blood Cancer Institute

Denver, Colorado, United States

Smilow Cancer Center-Yale

New Haven, Connecticut, United States

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Northwestern University

Chicago, Illinois, United States

The University of Chicago Medicine

Chicago, Illinois, United States

University of Maryland-Greenebaum Cancer Center

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Washington University

St Louis, Missouri, United States

Fred and Pamela Buffett Cancer Center

Omaha, Nebraska, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Weill Cornell Medicine

New York, New York, United States

Mount Sinai Hospital

New York, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

University of Pennsylvania Abramson Cancer Center

Philadelphia, Pennsylvania, United States

Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Md Anderson Cancer Center

Houston, Texas, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

University of Washington

Seattle, Washington, United States

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Az Sint-Jan Brugge - Oostende Av - Campus Sint-Jan

Bruges, Belgium

Universitair Ziekenhuis Antwerpen (Uza)

Edegem, Belgium

Jessa Ziekenhuis

Hasselt, Belgium

Universitair Ziekenhuis (Uz) Leuven

Leuven, Belgium

Universitaire Ziekenhuis Leuven - Gasthuisberg

Leuven, Belgium

Centre Hospitalier Universitaire (Chu) de Liege

Liège, Belgium

AZ DELTA

Roeselare, Belgium

Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

Princess Margaret Cancer Centre - University Health Network

Toronto, Ontario, Canada

Chu Sainte-Justine

Montreal, Quebec, Canada

Vancouver General Hospital

Vancouver, Canada

Klinikum Der Johann Wolfgang Goethe University

Frankfurt am Main, Germany

Universitatklinikum Freiburg

Freiburg im Breisgau, Germany

Universitatsklinikum Hamburg Eppendorf

Hamburg, Germany

Universitaetsklinikum Jena

Jena, Germany

University Hospital Mannheim

Mannheim, Germany

Universitaetsklinikum Regensburg

Regensburg, Germany

Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii

Bergamo, Italy

Aou Policlinico S. Orsola-Malpighi

Bologna, Italy

Fondazione Irccs Ca Granda Ospedale Maggiore Policlinico Di Milano Uo Dermatologia

Milan, Italy

Ospedale Pediatrico Bambino Gesu Irccs

Rome, Italy

Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore

Rome, Italy

Irccs Istituto Clinico Humanitas

Rozzano, Italy

A.O.U. Citta Della Salute E Della Scienza Di Torino

Torino, Italy

Hospital General Universitario Vall D Hebron

Barcelona, Spain

Hospital Clinic Barcelona Main

Barcelona, Spain

Hospital Universitario Virgen de La Arrixaca

El Palmar, Spain

Hospital Universitario Virgen de Las Nieves

Granada, Spain

Ico Institut Catala D Oncologia

Granvia de L'hospitalet 199-203, Spain

Hospital General Universitario Gregorio Maranon

Madrid, Spain

Hospital Universitario Ramon Y Cajal

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Regional Universitario de Malaga

Málaga, Spain

Hospital Clinico Universitario de Salamanca

Salamanca, Spain

Hospital Universitario Marques de Valdecilla

Santander, Spain

Hospital Universitario Virgen Del Rocio

Seville, Spain

Hospital Clinico Universitario de Valencia

Valencia, Spain

Hospital Universitari I Politecnic La Fe

Valencia, Spain

Queen Elizabeth Hospital

Birmingham, United Kingdom

Cambridge University Hospitals Nhs Foundation Trust

Cambridge, United Kingdom

University Hospital of Wales

Cardiff, United Kingdom

Queen Elizabeth University Hospital

Glasgow, United Kingdom

St James University Hospital

Leeds, United Kingdom

Clatterbridge Cancer Center

Liverpool, United Kingdom