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

Incyte

Status and phase

Terminated

Phase 1

Conditions

Hematologic Malignancies

Treatments

Drug: Calcineurin inhibitor

Drug: Itacitinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT03320642

INCB 39110-119/GRAVITAS-119

2017-002922-19 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment

84 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.