A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Where in Egyesült Államok
- Ann Arbor · University of MichiganTaking people
- Atlanta · Emory University/Winship Cancer InstituteTaking people
- Austin · St. David's South Austin Medical CenterTaking people
- Baltimore · John Hopkins HospitalTaking people
- Birmingham · University of Alabama BirminghamTaking people
- Boston · Dana-Farber Cancer InstituteTaking people
- Boston · Massachusetts General HospitalTaking people
- Charleston · Medical University of South CarolinaTaking people
- Chicago · Northwestern Memorial HospitalTaking people
- Chicago · University of IllinoisTaking people
- Denver · Colorado Blood Cancer InstituteTaking people
- Detroit · Henry Ford HospitalTaking people
- Duarte · City of Hope Medical CenterTaking people
- Grand Rapids · Corewell Health Hematology OncologyTaking people
- Greenville · Prisma Health-UpstateTaking people
- Hackensack · Hackensack University Medical CenterTaking people
- Kansas City · The University of Kansas Cancer CenterTaking people
- La Jolla · University of California San Diego Medical Center, Moores Cancer CenterTaking people
- Los Angeles · University of Southern CaliforniaTaking people
- Memphis · Baptist Cancer CenterTaking people
- Miami · Miami Cancer InstituteTaking people
- Morgantown · West Virginia University Cancer InstituteTaking people
- New Brunswick · Rutgers cancer Institute of NJTaking people
- Orlando · Orlando Health Cancer Institute Downtown OrlandoTaking people
- Pembroke Pines · Memorial Cancer InstituteTaking people
- Philadelphia · Jefferson University HospitalsTaking people
- Pittsburgh · UPMC Hillman Cancer CenterTaking people
- Portland · Oregon Health and Science UniversityTaking people
- Richmond · Virginia Commonwealth University/Massey Cancer CenterTaking people
- Rochester · University of Rochester Medical CenterTaking people
- Salt Lake City · Intermountain Blood and Marrow TransplantTaking people
- San Antonio · Texas Transplant InstituteTaking people
- San Francisco · UCSFTaking people
- Stony Brook · Stony Brook University Medical CenterTaking people
- Tucson · University of Arizona Cancer Center-Out Pt.Taking people
- Washington D.C. · Childrens National HospitalTaking people
- Winston-Salem · Wake Forest Baptist Medical CenterTaking people
Also in 12 other countries, 94 sites
Olaszország 17, Németország 16, Japán 13, Spanyolország 11, Franciaország 9, Egyesült Királyság 8, Kanada 8, Ausztria 5, Ausztrália 3, Hollandia 2, Dánia 1, Írország 1.
The registry text, word for word
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease (AXemplify-357)
This study will be conducted to compare the efficacy of axatilimab versus placebo in combination with corticosteroids as initial treatment for moderate or severe chronic graft-versus-host disease (cGVHD).
Inclusion: ≥ 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: Received more than 1 prior allo-HCT. Prior autologous HCT is allowed; 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; 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; Has overlap cGVHD, defined as simultaneous presence of features or characteristics of aGVHD in a patient with cGVHD; Active symptomatic myositis; Pregnant or breastfeeding; Other protocol-defined Inclusion/Exclusion Criteria may apply.