A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease | NCT06585774 | Trialant

A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease | NCT06585774 | Trialant

Ages Eligible for Study: Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

≥ 12 years of age at the time of informed consent.

New-onset moderate or severe cGVHD, as defined by the 2014 NIH Consensus Development Project Criteria for Clinical Trials in cGVHD, requiring systemic therapy.

History of allo-HCT from any donor HLA type (related or unrelated donor with any degree of HLA matching) using any graft source (bone marrow, peripheral blood stem cells, or cord blood). Recipients of myeloablative, nonmyeloablative, or reduced-intensity conditioning are eligible.

Adequate hematologic function with ANC ≥ 0.5 × 109/L independent of growth factors for at least 7 days prior to study entry.

Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

Received more than 1 prior allo-HCT. Prior autologous HCT is allowed.

Has overlap cGVHD, defined as simultaneous presence of features or characteristics of aGVHD in a patient with cGVHD.

Received more than 7 days of systemic corticosteroid treatment for cGVHD or unable to begin a prednisone dose ≥ 1.0 mg/kg per day (or methylprednisolone equivalent) for cGVHD.

Received previous systemic treatment for cGVHD, including extracorporeal photopheresis.

Systemic treatment with CNIs or mTOR inhibitors started within 2 weeks prior to C1D1.

Prior treatment with CSF-1R targeted therapies.

Active, uncontrolled bacterial, fungal, parasitic, or viral infection.

Evidence of relapse of the primary hematologic disease or treatment for relapse after the allo-HCT was performed, including DLIs for the treatment of molecular relapse.

History of acute or chronic pancreatitis.

Active symptomatic myositis.

History or current diagnosis of cardiac disease indicating significant risk of safety for participation in the study, such as uncontrolled or significant cardiac disease.

Severe renal impairment, that is, estimated CrCl < 30 mL/min measured or calculated by Cockcroft-Gault equation in adults and Schwartz formula in pediatric participants, or endstage renal disease on dialysis.

Impaired liver function, defined as total bilirubin > 1.5 × ULN and/or ALT and AST > 3 × ULN in participants with no evidence of liver cGVHD.

Pregnant or breastfeeding.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

University of Alabama BirminghamRecruiting

Birmingham, Alabama 35294, United States

University of Arizona Cancer Center-Out Pt.Recruiting

Tucson, Arizona 85719, United States

City of Hope Medical CenterRecruiting

Duarte, California 91010, United States

University of California San Diego Medical Center, Moores Cancer CenterRecruiting

La Jolla, California 92037, United States

University of Southern CaliforniaRecruiting

Los Angeles, California 90089, United States

UCSFRecruiting

San Francisco, California 94143, United States

Colorado Blood Cancer InstituteRecruiting

Denver, Colorado 80218, United States

Childrens National HospitalRecruiting

Washington D.C., District of Columbia 20010, United States

Miami Cancer InstituteRecruiting

Miami, Florida 33176, United States

Orlando Health Cancer Institute Downtown OrlandoRecruiting

Orlando, Florida 32806, United States

Memorial Cancer InstituteRecruiting

Pembroke Pines, Florida 33026, United States

Emory University-Winship Cancer InstituteRecruiting

Atlanta, Georgia 30322, United States

Northwestern Memorial HospitalRecruiting

Chicago, Illinois 60611, United States

University of IllinoisRecruiting

Chicago, Illinois 60612, United States

The University of Kansas Cancer CenterRecruiting

Kansas City, Kansas 66160, United States

John Hopkins HospitalRecruiting

Baltimore, Maryland 21287, United States

Massachusetts General HospitalRecruiting

Boston, Massachusetts 02114, United States

Dana Farber Cancer InstituteRecruiting

Boston, Massachusetts 02215, United States

University of MichiganRecruiting

Ann Arbor, Michigan 48109, United States

Henry Ford HospitalRecruiting

Detroit, Michigan 48202, United States

Corewell Health Hematology OncologyRecruiting

Grand Rapids, Michigan 49503, United States

Hackensack University Medical CenterRecruiting

Hackensack, New Jersey 07601, United States

Rutgers Cancer Institute of NjRecruiting

New Brunswick, New Jersey 08903, United States

University of Rochester Medical CenterRecruiting

Rochester, New York 14642, United States

Stony Brook University Medical CenterRecruiting

Stony Brook, New York 11794, United States

Wake Forest Baptist Medical CenterRecruiting

Winston-Salem, North Carolina 27157, United States

Oregon Health and Science UniversityRecruiting

Portland, Oregon 97239, United States

Jefferson University HospitalsRecruiting

Philadelphia, Pennsylvania 19107, United States

Medical University of South CarolinaRecruiting

Charleston, South Carolina 29425, United States

Prisma Health UpstateRecruiting

Greenville, South Carolina 29615, United States

Baptist Cancer CenterRecruiting

Memphis, Tennessee 38120, United States

St David'S South Austin Medical CenterRecruiting

Austin, Texas 78704, United States

Texas Transplant InstituteRecruiting

San Antonio, Texas 78229, United States

Intermountain Blood and Marrow TransplantRecruiting

Salt Lake City, Utah 84143, United States

Virginia Commonwealth University Massey Cancer CenterRecruiting

Richmond, Virginia 23298, United States

West Virginia University Cancer InstituteRecruiting

Morgantown, West Virginia 26506, United States

Royal Prince Alfred HospitalRecruiting

Sydney, New South Wales 02050, Australia

Royal Adelaide HospitalRecruiting

Adelaide, South Australia 05000, Australia

Austin Health Medical Oncology and Clinical HaematologyRecruiting

Heidelberg, Victoria 03084, Australia

Landeskrankenhaus Universitatsklinikum GrazRecruiting

Graz, A-8036, Austria

Innsbruck University HospitalRecruiting

Innsbruck, A-6020, Austria

Ordensklinikum Linz Gmbh ElisabethinenRecruiting

LINZ CET, A-4020, Austria

Akh Und Medizinische Universitat Wien Universitatsklinik Fur Innere Medizin IRecruiting

Vienna, 01090, Austria

St. Anna Childrens HospitalRecruiting

Vienna, 01090, Austria

Alberta'S Children HospitalRecruiting

Calgary, Alberta T3B 6A8, Canada

Stollery Children'S HospitalRecruiting

Edmonton, Alberta T6G 2B7, Canada

Bc Children'S HospitalRecruiting

Vancouver, British Columbia V6G1R8, Canada

Queen Elizabeth Ii Health Sciences CentreRecruiting

Halifax, Nova Scotia, Canada

Juravinski Cancer CentreRecruiting

Hamilton, Ontario L8V 5C2, Canada

Princess Margaret Cancer CenterRecruiting

Toronto, Ontario M5G 2M9, Canada

Hospital Maisonneuve RosemontRecruiting

Montreal, Quebec H1T 2M4, Canada

Vancouver General HospitalRecruiting

Vancouver, V5Z1M9, Canada

RigshospitaletRecruiting

Copenhagen, 02100, Denmark

Chu Amiens Picardie - Hopital SudRecruiting

Amiens, 80054, France

Institut Paoli CalmettesRecruiting

Marseille, 13273, France

Hopitaux de BraboisRecruiting

Nancy, 54511, France

Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-DieuRecruiting

Nantes, 44903, France

Chu de Nice - Hospital L ArchetRecruiting

Nice, 06202, France

Hospital Saint LouisRecruiting

Paris, 75010, France

Hospital Saint AntoineRecruiting

Paris, 75012, France

Hospices Civils de Lyon Centre Hospitalier Lyon SudRecruiting

Pierre-Bénite, 69310, France

Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-OncopoleRecruiting

Toulouse, 31059, France

University Medical Center Rwth AachenRecruiting

Aachen, D-52074, Germany

Charite Universitatsmedizin BerlinRecruiting

Berlin, 13353, Germany

Universitaetsklinikum Bonn, University Hospital BonnRecruiting

Bonn, 53127, Germany

University Clinic Carl Gustav Carus Technical University DresdenRecruiting

Dresden, 01307, Germany

University Hospital DuesseldorfRecruiting

Düsseldorf, 40225, Germany

Universitaetsklinikum ErlangenRecruiting

Erlangen, 91054, Germany

Universitatsklinikum EssenRecruiting

Essen, 45147, Germany

Universitatsklinikum Halle (Saale)Recruiting

Halle, 06120, Germany

University Hospital Schleswig-Holstein Campus KielRecruiting

Kiel, 24105, Germany

Universitatsklinikum LeipzigRecruiting

Leipzig, 04103, Germany

Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz IiiRecruiting

Mainz, 55131, Germany

Klinikum Der Philipps-Universitaet MarburgRecruiting

Marburg, 35043, Germany

Universitatsklinikum MunsterRecruiting

Münster, 48149, Germany

University Hospital of Ulm, Universitatsklinikum UlmRecruiting

Ulm, 89081, Germany

St. James HospitalRecruiting

Dublin, Ireland

Azienda Ospedaliero-Universitaria Di Alessandria Ss.Antonio E Biagio E Cesare ArrigoRecruiting

Alessandria, 15121, Italy

Azienda Ospedaliero Universitaria Delle MarcheRecruiting

Ancona, 60126, Italy

Aou Policlinico Consorziale Di BariRecruiting

Bari, 70124, Italy

Asst Degli Spedali Civili Di BresciaRecruiting

Brescia, 25123, Italy

Azienda Ospedaliero Universitaria Policlinico G.Rodolico San MarcoRecruiting

Catania, 95123, Italy

Irccs Azienda Ospedaliera Universitaria San MartinoRecruiting

Genova, 16132, Italy

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano NiguardaRecruiting

Milan, 20162, Italy

Ospedale San Raffaele - MilanoRecruiting

Milan, 20132, Italy

Azienda Ospedaliera Di Rilievo Nazionale Antonio CardarelliRecruiting

Naples, 80131, Italy

Azienda Ospedaliera Ospedali Riuniti Villa Sofia - CervelloRecruiting

Palermo, 90146, Italy

Irccs Fondazione Policlinico San MatteoRecruiting

Pavia, 27100, Italy

Grande Ospedale Metropolitano Bianchi-Melacrino-MorelliRecruiting

Reggio Calabria, 89133, Italy

Azienda Policlinico Umberto 1 Universita Sapienza Di RomaRecruiting

Rome, 00161, Italy

Ospedale Pediatrico Bambino Gesu IrccsRecruiting

Rome, 00165, Italy

I.R.C.C.S. Casa Sollievo Della SofferenzaRecruiting

San Giovanni Rotondo, 71013, Italy

Azienda Ospedaliera Card. G. PanicoRecruiting

Tricase, 73039, Italy

Centro Ricerche Cliniche Di VeronaRecruiting

Verona, 37134, Italy

Fujita Health University HospitalRecruiting

Aichi, 470-1192, Japan

Anjo Kosei HospitalRecruiting

Aichi-ken, 446-8602, Japan

Kyushu University HospitalRecruiting

Fukuoka, Japan

Hiroshima University HospitalRecruiting

Hiroshima, 734-8551, Japan

Kobe City Medical Center General HospitalRecruiting

Hyōgo, 650-0047, Japan

Tokai University HospitalRecruiting

Isehara Kanagawa, 259-1193, Japan

National Hospital Organization Kumamoto Medical CenterRecruiting

Kumamoto Kumamoto, 860-0008, Japan

Gunma Saiseikai Maebashi HospitalRecruiting

Maebashi, 371-0821, Japan

Tohoku University HospitalRecruiting

Miyagi, 980-8574, Japan

Okayama University HospitalRecruiting

Okayama Okayama, 700-0914, Japan

Osaka Metropolitan University HospitalRecruiting

Osaka, 545-8586, Japan

Hokkaido University HospitalRecruiting

Sapporo Hokkaido, 060-0814, Japan

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome HospitalRecruiting

Tokyo, 113-0021, Japan

Amsterdam University Medical CentreRecruiting

Amsterdam, 1081 HV, Netherlands

Maastricht University Medical CenterRecruiting

Maastricht, 6229 HX, Netherlands

Hospital General Universitario Vall D HebronRecruiting

Barcelona, 08035, Spain

Hospital de La Santa Creu I Sant PauRecruiting

Barcelona, 08041, Spain

Hospital Universitario DonostiaRecruiting

Donostia / San Sebastian, 20014, Spain

Institut Catala Doncologia Ico - Hospital Duran I Reynals LocationRecruiting

L'Hospitalet de Llobregat, 08906, Spain

Hospital Universitario de Gran Canaria Doctor NegrinRecruiting

Las Palmas de Gran Canaria, 35010, Spain

Hospital General Universitario Gregorio MaranonRecruiting

Madrid, 28007, Spain

Hospital Puerta de HierroRecruiting

Majadahonda, 28222, Spain

Hospital Universitario Virgen Del RocioRecruiting

Seville, 41013, Spain

Hospital Universitari I Politecnic La FeRecruiting

Valencia, 46026, Spain

Hospital Universitario Miguel ServetRecruiting

Zaragoza, 50009, Spain

Bristol Haematology and Oncology CentreRecruiting

Bristol, BS2 8ED, United Kingdom

Queen Elizabeth University HospitalRecruiting

Glasgow, G51 4TF, United Kingdom

Royal Marsden HospitalRecruiting

London, SM2 5PT, United Kingdom

University College London Hospitals (Uclh)Recruiting

London, WC1E 6AG, United Kingdom

Manchester University Nhs Foundation TrustRecruiting

Manchester, M13 9WL., United Kingdom

Nottingham University HospitalsRecruiting

Nottingham, NG5 1PB, United Kingdom

Plymouth Hospitals Nhs TrustRecruiting

Plymouth, PL6 8DH, United Kingdom