Itacitinib for Low Risk GVHD

Part of paid clinical trials in Duarte, California.

Sponsor
John Levine
Study ID
NCT03846479
Phase
PHASE2
Status
Completed

Conditions

  • GVHD
  • Graft-versus-host-disease
  • Low Risk Acute Graft-versus-host Disease

Eligibility Criteria

Sex
ALL
Age
12 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

Graft-versus-host disease (GVHD) is treated with high doses of systemic steroids which can lead to serious complications. A new blood test can identify patients whose GVHD is most likely to respond to well to treatment (low risk GVHD). This study will test whether patients with low risk GVHD can be successfully treated without steroids. Patients who participate with this study will be treated with itacitinib instead of steroids. Itacitinib is an experimental drug with an excellent safety record and appears to have activity as a GVHD treatment.

Key Dates

Start date
Mar 25, 2019
Status verified
Feb 2023
Primary completion
May 7, 2021
Completion
May 11, 2022

Study Design

Enrollment
70 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Itacitinib
    Itacitinib 200 mg administered orally daily

Primary Outcome Measure

Number of Patients Who Achieve CR or PR by Day 28 of Treatment [ Time Frame: Day 28 ]

Locations (14)

FacilityCityStateZIPSite coordinators
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-
Children's Hospital of Los AngelesLos AngelesCalifornia90027-
Children's Healthcare of AtlantaAtlantaGeorgia30322-
Emory UniversityAtlantaGeorgia30003-
University of Kansas Cancer CenterFairwayKansas66205-
Massachusetts General HospitalBostonMassachusetts02114-
Mayo ClinicRochesterMinnesota55905-
The Mount Sinai HospitalNew YorkNew York10029-
Ohio State UniversityColumbusOhio43210-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
University of Pennsylvania, Abramson Cancer CenterPhiladelphiaPennsylvania19104-
Vanderbilt UniversityNashvilleTennessee37232-
MD Anderson Cancer CenterHoustonTexas77030-
Fred Hutchinson Cancer Research CenterSeattleWashington98109-

Find similar trials in Duarte, CA

By research site
City of Hope Comprehensive Cancer Center· Duarte, CAChildren's Hospital of Los Angeles· Los Angeles, CAChildren's Healthcare of Atlanta· Atlanta, GAEmory University· Atlanta, GAUniversity of Kansas Cancer Center· Fairway, KSMassachusetts General Hospital· Boston, MA

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