About this trial
This study aims to evaluate the safety and efficacy of Gecacitinib in patients with steroid-refractory/dependent active chronic graft versus host disease (cGVHD).
Eligibility criteria
Qualifiers
Age ≥ 18 years, regardless of gender.
Underlying hematologic malignancies or non-malignant disorders having received allogeneic hematopoietic stem cell transplantation.
Steroid-refractory cGVHD is defined as meeting any of the following criteria: disease progression despite the use of prednisone ≥1 mg/kg/day (or equivalent dose of corticosteroids) for at least 1 week; OR, persistent disease symptoms with no improvement despite the use of prednisone ≥0.5 mg/kg/day or ≥1 mg/kg every other day (or equivalent dose of corticosteroids) for at least 4 weeks.
Steroid-dependent cGVHD is defined as the requirement for a maintenance dose of prednisone >0.25 mg/kg/day or >0.5 mg/kg every other day (or equivalent dose of corticosteroids) to prevent disease flare or progression, and failure to successfully taper the dose to a lower level in at least 2 separate attempts spaced ≥8 weeks apart.
Disqualifiers
Post-transplant lymphoproliferative disorder, or loss of full donor chimerism due to other reasons.
Previous use of, or current treatment with, other JAK inhibitors at the time of screening.
Congestive heart failure of New York Heart Association (NYHA) class III-IV, or documented history of diastolic or systolic dysfunction (e.g., left ventricular ejection fraction <40% by echocardiography), or uncontrolled/unstable angina or myocardial infarction.
Uncontrolled diabetes (blood glucose >250 mg/dL or >13.9 mmol/L).
Trial design
Treatments tested in this trial
- Gecacitinib