Trials / Not Yet Recruiting
Not Yet RecruitingNCT07197112
Study of Gecacitinib in the Treatment of Acute Graft-Versus-Host Disease After Failure of Ruxolitinib-containing Second-line Therapy
A Clinical Study of the Safety and Efficacy of Gimacabtinib Hydrochloride Tablets in Acute GVHD Patients After Failure of or Intolerance to Ruxolitinib-Based Second-Line Therapy.
- Status
- Not Yet Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- Sponsor
- Ruijin Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
An open-label, single-arm clinical trial to evaluate the safety and efficacy of gecacitinib tablets in patients with acute graft-versus-host disease (GVHD) who have failed or are intolerant to ruxolitinib-containing second-line therapy.
Detailed description
This is an open-label, single-arm study that plans to enroll 15 subjects with confirmed grade II-IV acute graft-versus-host disease (aGVHD). The primary endpoint is the overall response rate (ORR) on day 28 of gecacitinib treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Gecacitinib | Administer 50 mg twice daily for a minimum of 28 days. |
Timeline
- Start date
- 2025-10-01
- Primary completion
- 2027-02-01
- Completion
- 2027-12-01
- First posted
- 2025-09-29
- Last updated
- 2025-09-29
Source: ClinicalTrials.gov record NCT07197112. Inclusion in this directory is not an endorsement.