GRAVITAS-301: A Randomized Double-Blind Placebo-Controlled Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease
S
Sherif Farag, MD
Primary Investigator
Overview
The purpose of this study is to evaluate itacitinib or placebo in combination with corticosteroids as first-line treatment of participants with Grade II to IV acute graft-versus-host disease (aGVHD).
Description
The purpose of this study is to evaluate itacitinib or placebo in combination with corticosteroids as first-line treatment of participants with Grade II to IV acute graft-versus-host disease (aGVHD).
Eligibility
You may be eligible for this study if you meet the following criteria:
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Conditions:
Graft-versus-host Disease,hematologic malignancy,hematologic disorder
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Age: Between 18 Years - 100 Years
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Gender: All
Inclusion Criteria
Has undergone 1 allo-HSCT from any donor (related or unrelated with any degree of HLA matching) and any donor source (bone marrow, peripheral blood stem cells, or cord blood) for a hematologic malignancy or disorder
Recipients of myeloablative and reduced-intensity conditioning regimens are eligible
Willing to avoid pregnancy or fathering children
Able to swallow and retain oral medication
Exclusion Criteria
Has received more than 1 allo-HSCT
Has received more than 2 days of systemic corticosteroids for aGVHD
Presence of GVHD overlap syndrome
Presence of an active uncontrolled infection
Known human immunodeficiency virus infection
Active hepatitis B virus (HBV) or hepatitis C virus infection that requires treatment or at risk for HBV reactivation
Participants with evidence of relapsed primary disease, or participants who have been treated for relapse after the allo-HSCT was performed
Any corticosteroid therapy for indications other than GVHD at doses > 1 mg/kg per day methylprednisolone (or prednisone equivalent) within 7 days of randomization
Severe organ dysfunction unrelated to underlying GVHD, including:
*Cholestatic disorders or unresolved veno-occlusive disease of the liver
*Clinically significant or uncontrolled cardiac disease
*Clinically significant respiratory disease that requires mechanical ventilation support or 50% oxygen
Currently breast feeding
Received JAK inhibitor therapy after allo-HSCT for any indication. Treatment with a JAK inhibitor before allo-HSCT is permitted
Treatment with any other investigational agent, device, or procedure within 21 days (or 5 half-lives, whichever is greater) of enrollment
Any medical complications or conditions that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data
Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds
Additional Information:Has undergone 1 allo-HSCT from any donor (related or unrelated with any degree of HLA matching) and any donor source (bone marrow, peripheral blood stem cells, or cord blood) for a hematologic malignancy or disorder
Recipients of myeloablative and reduced-intensity conditioning regimens are eligible
Willing to avoid pregnancy or fathering children
Able to swallow and retain oral medication
Exclusion Criteria
Has received more than 1 allo-HSCT
Has received more than 2 days of systemic corticosteroids for aGVHD
Presence of GVHD overlap syndrome
Presence of an active uncontrolled infection
Known human immunodeficiency virus infection
Active hepatitis B virus (HBV) or hepatitis C virus infection that requires treatment or at risk for HBV reactivation
Participants with evidence of relapsed primary disease, or participants who have been treated for relapse after the allo-HSCT was performed
Any corticosteroid therapy for indications other than GVHD at doses > 1 mg/kg per day methylprednisolone (or prednisone equivalent) within 7 days of randomization
Severe organ dysfunction unrelated to underlying GVHD, including:
*Cholestatic disorders or unresolved veno-occlusive disease of the liver
*Clinically significant or uncontrolled cardiac disease
*Clinically significant respiratory disease that requires mechanical ventilation support or 50% oxygen
Currently breast feeding
Received JAK inhibitor therapy after allo-HSCT for any indication. Treatment with a JAK inhibitor before allo-HSCT is permitted
Treatment with any other investigational agent, device, or procedure within 21 days (or 5 half-lives, whichever is greater) of enrollment
Any medical complications or conditions that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data
Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds
Participants will not be paid for their participation.
Updated on
19 Apr 2024.
Study ID: 1708933720 (INCB39110-301)
