GRAVITAS-119: Itacitinib in Combination With Calcineurin Inhibitor-Based Interventions for the Prophylaxis of Graft-Versus Host Disease
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|ClinicalTrials.gov Identifier: NCT03320642|
Recruitment Status : Recruiting
First Posted : October 25, 2017
Last Update Posted : November 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hematologic Malignancies||Drug: Itacitinib Drug: Calcineurin inhibitor||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||85 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||GRAVITAS-119: A Single-Arm, Open-Label, Phase 1 Study of Itacitinib in Combination With Calcineurin Inhibitor-Based Interventions for the Prophylaxis of Graft-Versus Host Disease|
|Actual Study Start Date :||January 31, 2018|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2021|
Experimental: Itacitinib + Calcineurin Inhibitor (CNI) -Based Interventions
Itacitinib in combination with a CNI-based intervention.
Itacitinib administered orally once daily at the protocol-defined dose.
Other Name: INCB039110
Drug: Calcineurin inhibitor
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 [ Time Frame: Day 28 ]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).
- GVHD relapse-free survival rate [ Time Frame: Days 100, 180 and 365 ]Defined as the proportion of subjects who do not experience Grade II-IV acute GVHD (aGVHD), chronic GVHD (cGVHD) requiring systemic therapy, malignancy relapse or progression, or death due to any cause.
- Relapse-free survival [ Time Frame: Up to 1 year ]Defined as the interval between enrollment and malignancy relapse or progression, or death, whichever occurs first.
- Transplant-related mortality [ Time Frame: Up to 1 year ]Defined as the proportion of subjects who die due to causes other than malignancy relapse or progression.
- Median time to neutrophil and platelet engraftment [ Time Frame: Up to Day 28 ]Defined as the median time to achieve engraftment and hematologic recovery.
- Percentage of participants who achieve neutrophil and platelet engraftment [ Time Frame: Up to Day 28 ]Defined as the median time to achieve engraftment and hematologic recovery at prespecified time points.
- 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 [ Time Frame: Up to Day 180 ]Measured to assess the incidence of aGVHD.
- Proportion of subjects who are diagnosed with cGVHD by grade (mild, moderate, or severe) [ Time Frame: Up to 1 year ]Measured to assess the incidence of cGVHD.
- Infection rate [ Time Frame: Up to Day 180 ]Defined as the proportion of subjects who demonstrate an infection and/or cytomegalovirus reactivation.
- Overall survival [ Time Frame: Up to 1 year ]Defined as the interval between enrollment and death due to any cause.
- Participants with treatment-emergent adverse events (TEAEs) [ Time Frame: Up to approximately 200 days ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03320642
|Contact: Incyte Corporation Call Center (US)||firstname.lastname@example.org|
|Contact: Incyte Corporation Call Center (ex-US)||+800 email@example.com|
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|Study Director:||Rodica Morariu-Zamfir, MD||Incyte Corporation|