This trial employs a single-arm, single-center design, planning to enroll 25 patients diagnosed with grade II-IV aGVHD at one center. Patients meeting all inclusion criteria and no exclusion criteria will be enrolled. After enrollment, all patients will receive Gecacitinib combined with methylprednisolone sodium succinate for at least 28 days. After 28 days of Gecacitinib treatment, patients evaluated by the investigator as achieving Complete Response (CR) or Partial Response (PR) may continue study treatment for up to 24 weeks. If patients experience intolerance, disease progression, or require new systemic therapy, treatment will be adjusted.
All patients will receive the combined treatment of Gecacitinib and methylprednisolone sodium succinate in addition to the existing treatment regimen (Cyclosporin A 150\~250 μg/L and/or Tacrolimus 5\~12 μg/L) or other adjuvant treatments. Dosage: Gecacitinib PO 50mg Bid; Methylprednisolone sodium succinate IV 2mg/kg/d. After completing treatment, the Gecacitinib dose may be gradually reduced until discontinuation, per the investigator's discretion.The researchers adjusted the dosage of glucocorticoids according to the patient's condition: Methylprednisolone sodium succinate was gradually reduced. If disease progresses (aGVHD grade increases by one level) during Gecacitinib treatment, the investigator should initiate other salvage therapy as clinically needed. If aGVHD efficacy evaluation does not reach Complete Response(CR) or Partial Response(PR) after 28 days of Gecacitinib, the investigator should initiate other systemic therapy as clinically needed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Gecacitinib po. 50mg bid at least 28 days
Methylprednisolone sodium succinate IV 2mg/kg/d.
No. 899 Pinghai Road, Gusu District, Suzhou City, Jiangsu Province, First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGOverall Response Rate (ORR) for aGVHD at Day 28 of treatment
Defined as the percentage of patients achieving Complete Response (CR) + Partial Response (PR) at Day 28
Time frame: Day 28
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