Clareo Health | GRAVITAS-119: Itacitinib in Combination With Calcineurin Inhibitor-Based Interventions for the Prophylaxis of Graft-Versus Host Disease
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Incyte Corporation
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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.
