Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2025-12-25 @ 2:58 AM
NCT ID:
NCT07185633
Brief Summary:
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.
Detailed Description:
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:
NCT07185633
Study Brief:
Protocol Section:
NCT07185633