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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002922-19 | EudraCT Number |
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Study terminated by sponsor
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Itacitinib + Calcineurin Inhibitor (CNI) -Based Interventions | Experimental | Itacitinib in combination with a CNI-based intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Itacitinib | Drug | Itacitinib administered orally once daily at the protocol-defined dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Days 100, 180 and 365 |
| Relapse-free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rodica Morariu-Zamfir, MD | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anschutz Cancer Pavilion - University of Colorado | Aurora | Colorado | 80045 | United States | ||
| Winship Cancer Institute of Emory University |
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| Calcineurin inhibitor | Drug | 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. |
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Defined as the interval between enrollment and malignancy relapse or progression, or death, whichever occurs first. |
| Up to 1 year |
| Transplant-related mortality | Defined as the proportion of subjects who die due to causes other than malignancy relapse or progression. | Up to 1 year |
| Median time to neutrophil and platelet engraftment | Defined as the median time to achieve neutrophil and platelet engraftment. | 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. | Up to Day 28 |
| Donor Chimerism | 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. | 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. | Up to 1 year |
| Infection rate | Defined as the proportion of subjects who demonstrate an infection and/or cytomegalovirus reactivation. | Up to 1 year |
| Overall survival | Defined as the interval between enrollment and death due to any cause. | 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. | Up to approximately 200 days |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| University of Maryland - Greenebaum Cancer Center | Baltimore | Maryland | 21201 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| John Theurer Cancer Center, Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Froedtert Hospital and the Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Chru de Lille Hopital Claude Huriez | Lille | 59037 | France |
| Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu | Nantes | 44093 | France |
| Chu Vandoeuvre-Les-Nancy, Hopital Brabois | Vandœuvre-lès-Nancy | 54500 | France |
| Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii (Presidio Papa Giovanni Xxiii) | Bergamo | 24127 | Italy |
| Azienda Ospedaliera San Gerardo Di Monza | Monza | 20900 | Italy |
| Comitato Di Bioetica Della Fondazione Irccs Policlinico San Matteo | Pavia | 27100 | Italy |
| Hospital Puerta de Hierro | Majadahonda | 28222 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D000754 | Anemia, Refractory, with Excess of Blasts |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D006689 | Hodgkin Disease |
| D020522 | Lymphoma, Mantle-Cell |
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000753 | Anemia, Refractory |
| D000740 | Anemia |
| D009190 | Myelodysplastic Syndromes |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008223 | Lymphoma |
| D008228 | Lymphoma, Non-Hodgkin |
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| ID | Term |
|---|---|
| C000718170 | itacitinib |
| C000603457 | INCB039110 |
| D065095 | Calcineurin Inhibitors |
| ID | Term |
|---|---|
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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