A Phase 1 interventional study of Itacitinib and Calcineurin inhibitor in Hematologic Malignancies, sponsored by Incyte Corporation. Terminated at 17 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-21.
Sponsored by Incyte Corporation · Phase 1, Interventional, and Prevention
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).
Exclusion Criteria:
Itacitinib in combination with a CNI-based intervention.
Drug: Itacitinib · Drug: Calcineurin inhibitor
Itacitinib administered orally once daily at the protocol-defined dose.
Also known as: INCB039110
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.
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
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
Plan to share: No
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This study is terminated, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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Incyte Corporation