GRAVITAS-309: A Phase 2/3 Study of Itacitinib and Corticosteroids asInitial Treatment for Chronic Graft-Versus-Host Disease - GRAVITAS-309

Incyte Corporation0 个研究点目标入组 401 人开始时间: 2019年1月11日最近更新: 2024年1月8日

试验速览

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•1. Male or female, aged 18 years or older inclusive at the time of signing the ICF.
•2. Active, clinically diagnosed, moderate or severe cGVHD per NIH Consensus Criteria :
•a. Moderate cGVHD: At least 1 organ (except lung) with a score of 2, 3 or more organs involved with a score of 1 in each organ, or lung score of 1.
•b. Severe cGVHD: At least 1 organ with a score of 3, or lung score of 2 or 3.
•Note: Candidates who transition from active aGVHD to cGVHD without tapering off of corticosteroids (< 0.25 mg/kg per day methylprednisolone or equivalent)) ± CNI are also eligible.
•3. Underwent allo-HCT from any donor HLA type (related or unrelated donor with any degree of HLA matching) using any graft source (bone marrow, peripheral blood stem cells, or cord blood). Recipients of myeloablative, nonmyeloablative, or reduced intensity conditioning are
•4. KPS score = 60%.
•5. Evidence of myeloid and platelet engraftment, that is, ANC = 1.0 × 10E9/L and platelet count = 50 × 10E9/L. Note: Use of growth factor supplementation and transfusion support is allowed during the study; however, transfusion to reach a minimum platelet count for inclusion is not allowed within the 7 days before the screening laboratory assessment.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 294
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 107

•1. Has received more than 1 prior allo-HCT. Prior autologous HCT is
•2. Has received more than 3 days/72 hours of systemic corticosteroid
•treatment for cGVHD.
•3. Has received any other systemic treatment for cGVHD, including ECP. CNis initiated before randomization may be continued at the same or lower dose; topical/inhaled steroids are acceptable.
•4. Prior treatment with a JAK inhibitor within 8 weeks before
•randomization. Participants who received a JAK inhibitor for aGVHD are
•eligible only if they achieved CR or PR.
•5. cGVHD occurring after a nonscheduled DLI administered for preemptive
•treatment of malignancy recurrence. Participants who have
•received a scheduled DLI as part of their transplant procedure and not
•for management of malignancy relapse are eligible.

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