A Study to Evaluate 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)

Part of paid clinical trials in Duarte, California.

Sponsor
Incyte Corporation
Study ID
NCT07124078
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Chronic Graft-versus-host-disease

Eligibility Criteria

Sex
ALL
Age
2 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • INCA034176 — DRUG
    Axatilimab at the protocol-defined dose.
  • Best available Treatment (BAT) — DRUG
    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.

Study Details

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.

Key Dates

Start date
May 20, 2026
Status verified
Jun 2026
Primary completion
Jan 31, 2029
Completion
Jul 31, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Objective Response (OR) at 6 months [ Time Frame: 6 months ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010-
Children'S Hospital Los Angeles SpecialtLos AngelesCalifornia90027-
Lucile Packard Child Hospital EndPalo AltoCalifornia94304-
Childrens National Medical CenterWashington D.C.District of Columbia20010-
Adventhealth Pediatric Cellular Therapy and Blood and Marrow TransplantOrlandoFlorida32804-
Childrens Healthcare of AtlantaAtlantaGeorgia30329-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Levine Cancer InstituteCharlotteNorth Carolina28203-
Duke Cancer CenterDurhamNorth Carolina27710-
Childrens Hospital of PittsburghPittsburghPennsylvania15224-
Fred Hutchinson Cancer Research CenterSeattleWashington98109-

Find similar trials in Duarte, CA

By research site
City of Hope Medical Center· Duarte, CAChildren'S Hospital Los Angeles Specialt· Los Angeles, CALucile Packard Child Hospital End· Palo Alto, CAChildrens National Medical Center· Washington D.C., DCAdventhealth Pediatric Cellular Therapy and Blood and Marrow Transplant· Orlando, FLChildrens Healthcare of Atlanta· Atlanta, GA

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