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

Stopped early · Phase 1

Conditions studied: Hematologic Malignancies

In brief

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 facts

Study ID: NCT03320642
Run by: Incyte Corporation
People needed: 84
Starts: 2018-02-27
Expected to finish: 2022-02-17
Last updated by the study team: 2025-10-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

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

Full record on ClinicalTrials.gov

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