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NOT YET RECRUITING
NCT07185633
PHASE2

Study of Gecacitinib-corticosteroid as First-line Therapy for Grade II-IV Acute Graft Versus Host Disease

Sponsor: Bin Gu

View on ClinicalTrials.gov

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.

Official title: A Prospective, Single-Arm, Phase II Clinical Study of Gecacitinib-Corticosteroids as First-Line Treatment for Grade II-IV Acute Graft-Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2025-10-01

Completion Date

2027-10-01

Last Updated

2025-09-22

Healthy Volunteers

No

Conditions

Interventions

DRUG

Gecacitinib-Corticosteroid

Gecacitinib po. 50mg bid at least 28 days

DRUG

Methylprednisolone sodium succinate

Methylprednisolone sodium succinate IV 2mg/kg/d.