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

NCT03320642 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2025-10-21

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Rodica Morariu-Zamfir, MD · Incyte Corporation

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-27
Primary Completion
2021-02-25
Completion
2022-02-17
FDA Drug
Yes

Countries

  • United States
  • France
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03320642 on ClinicalTrials.gov