GRAVITAS-119: Itacitinib in Combination With Calcineurin Inhibitor-Based Interventions for the Prophylaxis of Graft-Versus Host Disease

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Incyte Corporation
Study ID
NCT03320642
Phase
PHASE1
Status
Terminated

Conditions

  • Hematologic Malignancies

Eligibility Criteria

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

Interventions

  • Itacitinib — DRUG
    Itacitinib administered orally once daily at the protocol-defined dose.
  • Calcineurin inhibitor — DRUG
    The CNI-based prophylaxis regimen will be identified by the investigator before the subject's enrollment and will consist of the combination of tacrolimus/methotrexate, cyclosporine A/mycophenolate mofetil or tacrolimus plus post-treatment cyclophosphamide. Antithymocyte globulin may be included at the treating investigator's discretion with the tacrolimus/methotrexate or cyclosporine A/mycophenolate mofetil combinations.

Study Details

The purpose of this study is to assess the impact and safety of itacitinib in combination with calcineurin inhibitor (CNI)-based interventions for the prophylaxis of graft-versus-host-disease (GVHD).

Key Dates

Start date
Feb 27, 2018
Status verified
Oct 2025
Primary completion
Feb 25, 2021
Completion
Feb 17, 2022

Study Design

Enrollment
84 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Itacitinib + Calcineurin Inhibitor (CNI) -Based Interventions
    Itacitinib in combination with a CNI-based intervention.

Primary Outcome Measure

Proportion of participants with hematologic recovery when itacitinib is added to GVHD prophylaxis treatment [ Time Frame: Day 28 ]

Locations (9)

FacilityCityStateZIPSite coordinators
Anschutz Cancer Pavilion - University of ColoradoAuroraColorado80045-
Winship Cancer Institute of Emory UniversityAtlantaGeorgia30322-
Loyola University Medical CenterMaywoodIllinois60153-
University of Maryland - Greenebaum Cancer CenterBaltimoreMaryland21201-
Washington University School of MedicineSt LouisMissouri63110-
John Theurer Cancer Center, Hackensack University Medical CenterHackensackNew Jersey07601-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
The Ohio State UniversityColumbusOhio43210-
Froedtert Hospital and the Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Aurora, CO

By research site
Anschutz Cancer Pavilion - University of Colorado· Aurora, COWinship Cancer Institute of Emory University· Atlanta, GALoyola University Medical Center· Maywood, ILUniversity of Maryland - Greenebaum Cancer Center· Baltimore, MDWashington University School of Medicine· St Louis, MOJohn Theurer Cancer Center, Hackensack University Medical Center· Hackensack, NJ

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