NCT03320642

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

GRAVITAS-119: A Single-Arm, Open-Label, Phase 1 Study of Itacitinib in Combination With Calcineurin Inhibitor-Based Interventions for the Prophylaxis of Graft-Versus Host Disease

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Hematologic Malignancies

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-02-27
• Primary completion: 2021-02-25
• Completion: 2022-02-17
• First posted: 2017-10-25
• Last updated: 2025-10-21

Locations

17 sites across 4 countries: United States, France, Italy, Spain

Regulatory

• FDA-regulated drug study