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

NCT ID: NCT03320642

Last Updated: 2025-10-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-27
• Study Completion Date: 2022-02-17

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Itacitinib + Calcineurin Inhibitor (CNI) -Based Interventions

Itacitinib in combination with a CNI-based intervention.

Group Type: EXPERIMENTAL

Itacitinib

Intervention Type: DRUG

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

Calcineurin inhibitor

Intervention Type: 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.

Interventions

Itacitinib

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

INCB039110

Eligibility Criteria

Inclusion Criteria

• Subjects with acute leukemia, chronic myelogenous leukemia, or myelodysplasia with no circulating blasts and < 5% blasts in the bone marrow.
• Subjects with non-Hodgkin lymphoma, including but not limited to chronic lymphocytic leukemia/small lymphocytic lymphoma, follicular, marginal zone, diffuse large B cell, or mantle cell lymphoma must have chemosensitive disease at time of transplant. Subjects with Hodgkin lymphoma with chemosensitive disease at the time of transplant.
• Must be candidates for reduced-intensity conditioning regimens.
• Must be candidates for peripheral blood stem cell transplants.
• Karnofsky Performance Status score ≥ 70% or Eastern Cooperative Oncology Group Performance Status score of 0 to 2.
• Serum creatinine ≤ 2.0 mg/dL or creatinine clearance ≥ 40 mL/min measured or calculated by Cockcroft-Gault equation.
• Be willing to avoid pregnancy or fathering children.

Exclusion Criteria

• Has previously received an allogenic hematopoietic stem cell transplant.
• Presence of an active uncontrolled infection.
• Known HIV infection.
• Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection that requires treatment or at risk for HBV reactivation.
• Prior malignancies.
• Severe organ dysfunction.
• Prior treatment with a JAK inhibitor or with an investigational agent, device, or procedure within 21 days of enrollment.
• Currently breastfeeding.
• Known allergies, hypersensitivity, or intolerance to any of the study medications.
• Receipt of live (including attenuated) vaccines during the study, or anticipation of need for such a vaccine during the study.
• History of primary idiopathic myelofibrosis or any severe marrow fibrosis that would prolong neutrophil engraftment to > 28 days after transplant.
• Post-transplant maintenance therapy for the hematologic malignancy or plans to initiate maintenance therapy during study treatment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Incyte Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rodica Morariu-Zamfir, MD

Role: STUDY_DIRECTOR

Incyte Corporation

Locations

Anschutz Cancer Pavilion - University of Colorado

Aurora, Colorado, United States

Winship Cancer Institute of Emory University

Atlanta, Georgia, United States

Loyola University Medical Center

Maywood, Illinois, United States

University of Maryland - Greenebaum Cancer Center

Baltimore, Maryland, United States

Washington University School of Medicine

St Louis, Missouri, United States

John Theurer Cancer Center, Hackensack University Medical Center

Hackensack, New Jersey, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

The Ohio State University

Columbus, Ohio, United States

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Chru de Lille Hopital Claude Huriez

Lille, , France

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

Nantes, , France

Chu Vandoeuvre-Les-Nancy, Hopital Brabois

Vandœuvre-lès-Nancy, , France

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

Bergamo, , Italy

Azienda Ospedaliera San Gerardo Di Monza

Monza, , Italy

Comitato Di Bioetica Della Fondazione Irccs Policlinico San Matteo

Pavia, , Italy

Hospital Puerta de Hierro

Majadahonda, , Spain

Hospital Clinico Universitario de Valencia

Valencia, , Spain

Countries

United States; France; Italy; Spain

Other Identifiers

2017-002922-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

INCB 39110-119/GRAVITAS-119

Identifier Type: -

Identifier Source: org_study_id