A Study of Itacitinib for the Treatment of Chronic Graft Versus Host Disease (cGVHD)

Part of paid clinical trials in Denver, Colorado.

Sponsor
SCRI Development Innovations, LLC
Study ID
NCT04200365
Phase
PHASE2
Status
Terminated

Conditions

  • Chronic Graft-versus-host-disease

Eligibility Criteria

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

Interventions

  • Itacitinib — DRUG
    Itacitinib will be administered orally once daily for up to 24 months.

Study Details

This study is being done in patients who have been receiving corticosteroids or other immunosuppressive therapies for the treatment of cGVHD for at least 6 months. The purpose of this study is to find out if itacitinib in combination with corticosteroids or other immunosuppressive therapies is safe and effective in people with cGVHD.

Key Dates

Start date
Jun 5, 2020
Status verified
Aug 2024
Primary completion
Sep 7, 2023
Completion
Sep 7, 2023

Study Design

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

Arms

  • Experimental: Itacitinib

Primary Outcome Measure

cGVHD Overall Response Rate (ORR) at 6 Months on Treatment [ Time Frame: Response assessed Day 1 of every cycle up until the end of treatment, up to 24 months. This outcome measure is the ORR for all patients once they have been on treatment for 6 months. ]

Locations (5)

FacilityCityStateZIPSite coordinators
Colorado Blood Cancer InstituteDenverColorado80218-
The Sarah Cannon Research InstituteNashvilleTennessee37203-
South Austin Medical CenterAustinTexas78704-
Texas Oncology - Sammons Cancer CenterDallasTexas75246-
Texas Transplant InstituteSan AntonioTexas78229-

Find similar trials in Denver, CO

By research site
Colorado Blood Cancer Institute· Denver, COThe Sarah Cannon Research Institute· Nashville, TNSouth Austin Medical Center· Austin, TXTexas Oncology - Sammons Cancer Center· Dallas, TXTexas Transplant Institute· San Antonio, TX

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