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

PHASE1TerminatedINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

February 27, 2018

Primary Completion Date

February 25, 2021

Study Completion Date

February 17, 2022

Conditions
Hematologic Malignancies
Interventions
DRUG

Itacitinib

Itacitinib administered orally once daily at the protocol-defined dose.

DRUG

Calcineurin inhibitor

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.

Trial Locations (17)

10065

Memorial Sloan Kettering Cancer Center, New York

20900

Azienda Ospedaliera San Gerardo Di Monza, Monza

21201

University of Maryland - Greenebaum Cancer Center, Baltimore

24127

Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii (Presidio Papa Giovanni Xxiii), Bergamo

27100

Comitato Di Bioetica Della Fondazione Irccs Policlinico San Matteo, Pavia

28222

Hospital Puerta de Hierro, Majadahonda

30322

Winship Cancer Institute of Emory University, Atlanta

43210

The Ohio State University, Columbus

44093

Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu, Nantes

46010

Hospital Clinico Universitario de Valencia, Valencia

53226

Froedtert Hospital and the Medical College of Wisconsin, Milwaukee

54500

Chu Vandoeuvre-Les-Nancy, Hopital Brabois, Vandœuvre-lès-Nancy

59037

Chru de Lille Hopital Claude Huriez, Lille

60153

Loyola University Medical Center, Maywood

63110

Washington University School of Medicine, St Louis

80045

Anschutz Cancer Pavilion - University of Colorado, Aurora

07601

John Theurer Cancer Center, Hackensack University Medical Center, Hackensack

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Incyte Corporation

INDUSTRY

NCT03320642 - GRAVITAS-119: Itacitinib in Combination With Calcineurin Inhibitor-Based Interventions for the Prophylaxis of Graft-Versus Host Disease | Biotech Hunter | Biotech Hunter