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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
84
Itacitinib administered orally once daily at the protocol-defined dose.
The CNI-based prophylaxis regimen will be identified by the investigator before the subject's enrollment and will consist of the combination of tacrolimus/methotrexate, cyclosporine A/mycophenolate mofetil or tacrolimus plus post-treatment cyclophosphamide. Antithymocyte globulin may be included at the treating investigator's discretion with the tacrolimus/methotrexate or cyclosporine A/mycophenolate mofetil combinations.
Anschutz Cancer Pavilion - University of Colorado
Aurora, Colorado, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Proportion of participants with hematologic recovery when itacitinib is added to GVHD prophylaxis treatment
Hematologic recovery defined as demonstrating both neutrophil recovery (ANC ≥ 500/mm\^3 for 3 consecutive measurements) and platelet recovery (platelet count ≥ 20,000/mm\^3 with no requirement for platelet transfusion in the preceding 3 days).
Time frame: Day 28
GVHD relapse-free survival rate
Defined as the proportion of subjects who do not experience Grade III-IV acute GVHD (aGVHD), chronic GVHD (cGVHD) requiring systemic therapy, malignancy relapse or progression, or death due to any cause.
Time frame: Days 100, 180 and 365
Relapse-free survival
Defined as the interval between enrollment and malignancy relapse or progression, or death, whichever occurs first.
Time frame: Up to 1 year
Transplant-related mortality
Defined as the proportion of subjects who die due to causes other than malignancy relapse or progression.
Time frame: Up to 1 year
Median time to neutrophil and platelet engraftment
Defined as the median time to achieve neutrophil and platelet engraftment.
Time frame: Up to Day 28
Percentage of participants who achieve neutrophil and platelet engraftment
Defined as the median time to achieve engraftment and hematologic recovery at prespecified time points.
Time frame: Up to Day 28
Donor Chimerism
Time frame: Up to Day 28
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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
...and 7 more locations
Proportion of subjects who are diagnosed with Grade II-IV aGVHD, by each grade and by Grade III/IV
Measured to assess the incidence of aGVHD.
Time frame: Days 100 and Days 180
Proportion of subjects who are diagnosed with cGVHD by grade (mild, moderate, or severe)
Measured to assess the incidence of cGVHD.
Time frame: Up to 1 year
Infection rate
Defined as the proportion of subjects who demonstrate an infection and/or cytomegalovirus reactivation.
Time frame: Up to 1 year
Overall survival
Defined as the interval between enrollment and death due to any cause.
Time frame: Up to 1 year
Participants with Grade 3-5 treatment-emergent adverse events (TEAEs)
TEAE is defined as either an adverse event (AE) reported for the first time or worsening of a pre-existing condition after the first dose of study treatment.
Time frame: Up to approximately 200 days