A Study of Axatilimab at 3 Different Doses in Participants With Chronic Graft Versus Host Disease (cGVHD)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Syndax Pharmaceuticals
Study ID
NCT04710576
Phase
PHASE2
Status
Recruiting
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Conditions

  • Chronic Graft-versus-host-disease

Eligibility Criteria

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

Interventions

  • Axatilimab — DRUG
    Axatilimab is a high-affinity antibody targeting the colony stimulating factor 1 receptor (CSF-1R). CSF-1R signaling has been demonstrated in nonclinical studies to be the key regulatory pathway involved in the expansion and infiltration of donor-derived macrophages that mediate the disease processes involved in cGVHD.

Study Details

This is a Phase 2 study to evaluate the efficacy, safety, and tolerability of axatilimab at 3 different dose levels in participants with recurrent or refractory active chronic graft versus host disease (cGVHD) who have received at least 2 prior lines of systemic therapy.

Key Dates

Start date
Mar 4, 2021
Status verified
May 2026
Primary completion
Apr 7, 2023
Completion
Sep 30, 2027

Study Design

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

Arms

  • Experimental: Axatilimab Dose Cohort 1
    Participants will be administered axatilimab 0.3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks for up to 2 years.
  • Experimental: Axatilimab Dose Cohort 2
    Participants will be administered axatilimab 1 mg/kg IV every 2 weeks for up to 2 years.
  • Experimental: Axatilimab Dose Cohort 3
    Participants will be administered axatilimab 3 mg/kg IV every 4 weeks for up to 2 years.

Primary Outcome Measure

Overall Response Rate (ORR) in the First 6 Cycles as Defined by the 2014 NIH Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-Versus-Host Disease (cGVHD) [ Time Frame: First 6 cycles (up to Cycle 7 Day 1; each cycle = 4 weeks) ]

Central Contacts

Locations (47)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-
University of Alabama at Birmingham - Children's of AlabamaBirminghamAlabama35233-
City of HopeDuarteCalifornia91010-
University of California, Los Angeles (UCLA) - Medical CenterLos AngelesCalifornia90059-
University of Southern California Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
Stanford Cancer CenterStanfordCalifornia94305-
Children's National Medical CenterWashington D.C.District of Columbia20010-
University of Florida (UF)GainesvilleFlorida32610-
Mayo Clinic - JacksonvilleJacksonvilleFlorida32224-
University of MiamiMiamiFlorida33136-
AdventHealth OrlandoOrlandoFlorida32806-
MoffittTampaFlorida33612-
Emory UniversityAtlantaGeorgia30322-
Northside HospitalAtlantaGeorgia30342-
The University of Chicago Medical Center (UCMC)ChicagoIllinois60637-
Franciscan Health IndianapolisIndianapolisIndiana46237-
Indiana University Health Melvin and Bren Simon Cancer CenterIndianapolisIndiana46202-
Tulane University Medical CenterNew OrleansLouisiana70112-
Johns Hopkins Kimmel Cancer CenterBaltimoreMaryland21231-2410-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
University of Massachusetts Memorial Medical CenterWorcesterMassachusetts01655-
University of MichiganAnn ArborMichigan48084-
Barbara Ann Karmanos Cancer InstituteDetroitMichigan48201-
Henry Ford HospitalDetroitMichigan48202-
University of MinnesotaMinneapolisMinnesota55455-
Mayo Clinic - RochesterRochesterMinnesota55905-
Washington University School of MedicineSt LouisMissouri63110-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-
Weill Medical College of Cornell UniversityNew YorkNew York10022-
Stony Brook University Medical CenterStony BrookNew York11794-
Wake ForestWinston-SalemNorth Carolina27157-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
The Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
The Cleveland Clinic FoundationLyndhurstOhio44195-
University of Oklahoma - Health Sciences CenterOklahoma CityOklahoma73104-
Oregon Health & Science UniversityPortlandOregon97239-
University of Pittsburgh Medical Center - Hillman Cancer CenterPittsburghPennsylvania15232-
Vanderbilt University Medical CenterNashvilleTennessee37232-
MD Anderson Cancer CenterHoustonTexas77030-
Intermountain HealthcareSalt Lake CityUtah84111-
University of UtahSalt Lake CityUtah84112-
University of Virginia Medical CenterCharlottesvilleVirginia22908-
Fred Hutchinson Cancer Research CenterSeattleWashington98109-
University of Wisconsin - Carbone Cancer CenterMadisonWisconsin53792-
Froedtert Hospital and the Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALUniversity of Alabama at Birmingham - Children's of Alabama· Birmingham, ALCity of Hope· Duarte, CAUniversity of California, Los Angeles (UCLA) - Medical Center· Los Angeles, CAUniversity of Southern California Norris Comprehensive Cancer Center· Los Angeles, CAStanford Cancer Center· Stanford, CA

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