A Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease - GRAVITAS-309

INCYTE CORPORATIO0 个研究点目标入组 266 人开始时间: 2021年1月19日最近更新: 2021年4月5日

适应症

试验速览

暂无简介。

•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) ± 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 eligible.
•4. KPS score = 60%.
•5. Evidence of myeloid and platelet engraftment, that is, ANC = 1.0 × 109/L and platelet count = 25 × 109/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 213
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 52

•1. Has received more than 1 prior allo-HCT. Prior autologous HCT is allowed.
•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. Prior and concomitant use of CNIs as well as topical/inhaled steroids is 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 pre-emptive 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.

发起方

INCYTE CORPORATIO