Graft Versus Host Disease (GvHD) Clinical Trials

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A Phase 2, Randomized, Open-Label Study of Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Disease After at Least 2 Prior Lines of Systemic Therapy (AGAVE-256)

Status: Recruiting
Location: See all (42) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study will be conducted to compare Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 17
Healthy Volunteers: f
View:

• Aged ≥ 2 to \< 18 years at the time of signing the informed consent.

• Active, moderate to severe cGVHD, requiring systemic immune suppression.

• Participants with refractory or recurrent cGVHD who have received at least 2 lines of systemic therapy, including corticosteroids and ruxolitinib.

• Concomitant use of systemic corticosteroids is allowed. Participants on systemic corticosteroids must be on a stable dose of corticosteroids for at least 2 weeks prior to C1D1. Topical and inhaled corticosteroid agents are allowed.

• Participants must accept to be treated with one of the following BAT options on C1D1: CNI (cyclosporine or tacrolimus), ECP, MMF, an mTOR inhibitor (everolimus or sirolimus), rituximab, imatinib, methotrexate, or ibrutinib.

• 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.

Locations
United States
California
City of Hope Medical Center
RECRUITING
Duarte
Lucile Packard Child Hospital End
NOT_YET_RECRUITING
Palo Alto
Washington, D.c.
Childrens National Medical Center
NOT_YET_RECRUITING
Washington D.c.
Florida
Adventhealth Pediatric Cellular Therapy and Blood and Marrow Transplant
NOT_YET_RECRUITING
Orlando
Georgia
Childrens Healthcare of Atlanta
NOT_YET_RECRUITING
Atlanta
Michigan
Congenital Heart Center At Mott Children'S Hospital
WITHDRAWN
Ann Arbor
North Carolina
Levine Cancer Institute
NOT_YET_RECRUITING
Charlotte
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Pennsylvania
Childrens Hospital of Pittsburgh
NOT_YET_RECRUITING
Pittsburgh
Washington
Fred Hutchinson Cancer Research Center
NOT_YET_RECRUITING
Seattle
Other Locations
Belgium
Hôpital Universitaire Des Enfants Reine Fabiola
NOT_YET_RECRUITING
Brussels
Universite Catholique de Louvain (Ucl) - Cliniques Universitaires Saint-Luc
NOT_YET_RECRUITING
Woluwe-saint-lambert
Germany
Charite Campus Virchow
NOT_YET_RECRUITING
Berlin
Klinikum Der Johann Wolfgang Goethe-Universitaet
RECRUITING
Frankfurt Am Main
Universitaetsklinikum Freiburg Zentrum Fuer Kinderheilkunde- Und Jugendmedizin Klinik Iv: Paediatris
NOT_YET_RECRUITING
Freiburg Im Breisgau
Universitaetsklinikum Hamburg-Eppendorf
NOT_YET_RECRUITING
Hamburg
Medizinische Hochschule Hannover (Mhh) - Zentrum Fuer Kinderheilkunde Und Jugendmedizin - Klinik Fue
NOT_YET_RECRUITING
Hanover
Universitaeres Krebszentrum Leipzig (Uccl)-Universitatsklinikum Leipzig Aor
WITHDRAWN
Leipzig
University Hospital Regensburg
NOT_YET_RECRUITING
Regensburg
Universitaetsklinikum Tuebingen
WITHDRAWN
Tübingen
Italy
Irccs - Aou Di Bologna - Sant'Orsola Malpighi
NOT_YET_RECRUITING
Bologna
Irccs Istituto G. Gaslini, Universita Di Genova
NOT_YET_RECRUITING
Genova
Fondazione Irccs San Gerardo Dei Tintori
NOT_YET_RECRUITING
Monza
Azienda Ospedaliera Universitaria Di Padova
NOT_YET_RECRUITING
Padua
Fondazione Irccs Policlinico San Matteo Di Pavia Oncoematologia Pediatrica, Universita Di Pavia
NOT_YET_RECRUITING
Pavia
Irccs Ospedale Pediatrico Bambino Gesu
RECRUITING
Rome
Spain
Hospital Universitario Vall D'Hebron
RECRUITING
Barcelona
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Regional Universitario de Malaga- Hospital Materno Infantil
RECRUITING
Málaga
Hospital Universitario Virgen de La Arrixaca
RECRUITING
Murcia
Universitat de Valencia - Hospital Universitari I Politecnic La Fe de Valencia (Hospital La Fe Bulev
RECRUITING
Valencia
United Kingdom
Birmingham Children'S Hospital - Birmingham Women'S and Children'S Nhs Foundation Trust
NOT_YET_RECRUITING
Birmingham
Addenbrooke'S Hospital - Cambridge University Hospitals Nhs Foundation Trust
RECRUITING
Cambridge
The Royal Hospital For Children - Glasgow Health Board
RECRUITING
Glasgow
Leeds Childrens Hospital
RECRUITING
Leeds
Great Ormond Street Hospital Nhs Foundation Trust
RECRUITING
London
Royal Marsden Hospital (Sutton) - Royal Marsden Nhs Foundation Trust
WITHDRAWN
London
St Mary'S Hospital, Paddington - Imperial College Healthcare Nhs Trust
RECRUITING
London
University College London Hospitals - University College London Hospitals Nhs Foundation Trust
WITHDRAWN
London
Royal Manchester Children'S Hospital - Manchester University Nhs Foundation Trust
RECRUITING
Manchester
Royal Victoria Infirmary - the Newcastle Upon Tyne Hospitals Nhs Foundation Trust
NOT_YET_RECRUITING
Newcastle
Sheffield Children'S Hospital - Sheffield Children'S Nhs Foundation Trust
RECRUITING
Sheffield
Contact Information
Primary
Incyte Corporation Call Center (US)
medinfo@incyte.com
1.855.463.3463
Backup
Incyte Corporation Call Center (ex-US)
eumedinfo@incyte.com
+800 00027423
Time Frame
Start Date: 2026-05-31
Estimated Completion Date: 2029-07-31
Participants
Target number of participants: 60
Treatments
Experimental: Axatilimab
Axatilimab at the protocol-defined dose.
Experimental: Best available Treatment (BAT)
Best Available Therapy (BAT) will be selected by the Investigator for each participant. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
Related Therapeutic Areas
Chronic Graft Versus Host Disease (cGvHD)
Graft Versus Host Disease (GvHD)
Sponsors
Leads: Incyte Corporation

This content was sourced from clinicaltrials.gov

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