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

• Status: Terminated
• Trial end date: 2021-02-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation
• Treatments: Calcineurin Inhibitors

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.