A Study of Jaktinib for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease.
Acute Graft-Versus-Host Disease
About this trial
This is an interventional treatment trial for Acute Graft-Versus-Host Disease focused on measuring GVHD
Eligibility Criteria
Inclusion Criteria:
- Have undergone first allogeneic hematopoietic stem cell transplantation (allo-HSCT) from any donor source using bone marrow, peripheral blood stem cells, or cord blood for hematologic malignancies. Recipients of nonmyeloablative and myeloablative conditioning regimens are eligible.
- Clinically suspected Grades II to IV acute GVHD according to NCCN guidelines 2020 V2.0, occurring after allo-HSCT with any conditioning regimen and any anti-GVHD prophylactic program.
- Subjects with steroid-refractory acute GVHD, defined as any of the following:
Subjects with progressive GVHD (ie, increase in stage in any organ system or any new organ involvement) after 3-5 days of primary treatment with methylprednisolone ≥ 2 mg/kg per day (or equivalent) ± Calcineurin inhibitors(CNI);Subjects with GVHD that has not improved (ie, decrease in stage in at least 1 involved organ system) after 5-7 days of primary treatment with methylprednisolone ≥ 2 mg/kg per day (or equivalent) ± Calcineurin inhibitors(CNI);Subjects who Corticosteroid dependence(ie, begin corticosteroids at 2.0 mg/kg per day, demonstrate response, but progress before decrease from the initial starting dose of corticosteroids is achieved).
- ECOG: 0-2;
- Life expectancy > 4 weeks;
- Ability for oral drug intake;
- Willingness to comply with all study visits and procedures.
Exclusion Criteria:
- Has received more than 2 allo-HSCT.
- Acute GvHD occurring after non-scheduled donor leukocyte infusion (DLI) administered.
- Has received more than 1 systemic treatment in addition to corticosteroids for acute GVHD.
- Presence of an active uncontrolled infection.
- Serum creatinine > 1.5 ULN or creatinine clearance < 30 mL/min calculated by Cockroft-Gault equation.
- Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds.
Sites / Locations
- Henan Tumor Hospital
Arms of the Study
Arm 1
Experimental
Jaktinib treatment
Participants began oral administration of Jaktinib at 75mg twice daily (BID); if stable after the first 3 days of treatment, the dose could be increased to 100mg BID Or continue 75mg BID treatment .