GRAVITAS-119: Itacitinib in Combination With Calcineurin Inhibitor-Based Interventions for the Pr… (NCT03320642) | Clinical Trial Compass
TerminatedPhase 1
GRAVITAS-119: Itacitinib in Combination With Calcineurin Inhibitor-Based Interventions for the Prophylaxis of Graft-Versus Host Disease
Stopped: Study terminated by sponsor
United States84 participantsStarted 2018-02-27
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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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 medica…
What they're measuring
1
Proportion of participants with hematologic recovery when itacitinib is added to GVHD prophylaxis treatment