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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Incyte Corporation
Study ID
NCT06388564
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Chronic Graft-versus-host-disease

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Axatilimab — DRUG
    Axatilimab will be administered at protocol defined dose.
  • Ruxolitinib — DRUG
    Ruxolitinib will be administered at protocol defined dose.
  • Corticosteroids — DRUG
    Corticosteroids will be administered at protocol defined dose.

Study Details

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.

Key Dates

Start date
Oct 11, 2024
Status verified
May 2026
Primary completion
Jun 1, 2027
Completion
Dec 1, 2029

Study Design

Enrollment
130 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Group A
    Axatilimab will be administered at a protocol defined starting dose plus ruxolitinib at a protocol defined starting dose.
  • Experimental: Treatment Group B
    Ruxolitinib will be administered at a protocol defined starting dose.
  • Experimental: Treatment Group C
    Corticosteroids alone will be administered at a protocol defined starting dose.

Primary Outcome Measure

Objective Response Rate [ Time Frame: 6 months ]

Locations (25)

FacilityCityStateZIPSite coordinators
Mayo Clinic HospitalPhoenixArizona85054-
City of Hope Medical CenterDuarteCalifornia91010-
University of California-Los Angeles Medl Cntr-Oncology Center Bowyer ClinicLos AngelesCalifornia90095-
Stanford Cancer CenterStanfordCalifornia94305-
University of Colorado Cancer CenterAuroraColorado80045-
Colorado Blood Cancer InstituteDenverColorado80218-
Smilow Cancer Center-YaleNew HavenConnecticut06510-
Mayo Clinic JacksonvilleJacksonvilleFlorida32224-
Northwestern UniversityChicagoIllinois60611-
The University of Chicago MedicineChicagoIllinois60637-
University of Maryland-Greenebaum Cancer CenterBaltimoreMaryland21201-
Washington UniversitySt LouisMissouri63110-
Fred and Pamela Buffett Cancer CenterOmahaNebraska68198-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10021-
Mount Sinai HospitalNew YorkNew York10029-
Weill Cornell MedicineNew YorkNew York10021-
Cleveland ClinicClevelandOhio44195-
The Ohio State UniversityColumbusOhio43210-
University of Pennsylvania Abramson Cancer CenterPhiladelphiaPennsylvania19104-
Hillman Cancer CenterPittsburghPennsylvania15232-
Vanderbilt University Medical CenterNashvilleTennessee37232-
Md Anderson Cancer CenterHoustonTexas77030-
Fred Hutchinson Cancer CenterSeattleWashington98109-
University of WashingtonSeattleWashington98195-
Froedtert & the Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Phoenix, AZ

By research site
Mayo Clinic Hospital· Phoenix, AZCity of Hope Medical Center· Duarte, CAUniversity of California-Los Angeles Medl Cntr-Oncology Center Bowyer Clinic· Los Angeles, CAStanford Cancer Center· Stanford, CAUniversity of Colorado Cancer Center· Aurora, COColorado Blood Cancer Institute· Denver, CO

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