Efficacy and Tolerability of Entospletinib in Combination With Systemic Corticosteroids as First-Line Therapy in Adults With Chronic Graft Versus Host Disease (cGVHD)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Willing and able to provide written informed consent
Male or non-pregnant, non-lactating, females
Newly diagnosed cGVHD defined by:
* At least 100 days after receiving any allogeneic hematopoietic stem cell transplant AND
* Receiving a new course of systemic corticosteroids (≥ 0.5 mg/kg/day) as first-line cGVHD therapy at least 1 day and no more than 21 days prior to first dose of ENTO/Placebo AND
* Moderate to severe cGVHD as assessed by NIH cGVHD Diagnosis and Staging Criteria (NCDSC) with at least three organ systems involved OR one organ system with a score of 2 OR lung organ score = 1
Individuals who have undergone transplant for hematologic malignancy are required to be in complete remission.
Have either a normal ECG or one with abnormalities that are considered clinically insignificant by the investigator in consultation with the Sponsor
You may not be if
Inability to begin systemic corticosteroids therapy at a dose of ≥ 0.5 mg/kg/day (or equivalent)
Uncontrolled infection within 4 weeks prior to randomization
History of the following therapies in the post-transplant period:
* B cell depleting biologic agents
* CD19 CAR-T cells based therapies
* BTK/SYK/JAK/PI3K inhibitors
* Phototherapy-unless administered for acute GVHD
Treatment of cGVHD with anti-thymocyte globulins (ATG), or campath within 60 days of screening visit unless used for treatment of acute GVHD
Severe organ dysfunction manifested during screening period:
* Requiring supplemental oxygen at more than 2 L/min
