Study of Gecacitinib-corticosteroid as First-line Therapy for Grade II-IV Acute Graft Versus Host Disease
ConditionaGVHD
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBin Gu
About this trial
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.
Eligibility criteria
Qualifiers
1. Voluntarily sign informed consent form (ICF); age ≥18 years at ICF signing.
2. Recipients who underwent non-myeloablative, myeloablative, or reduced-intensity allo-HSCT using bone marrow or peripheral blood stem cells.
3. Have received systemic corticosteroid therapy for no more than 2 days (48 hours).
4. Documented myeloid and platelet engraftment: Absolute Neutrophil Count (ANC) >0.5 × 10⁹/L for 3 consecutive days, platelet count >20 × 10⁹/L for 7 consecutive days without transfusion support (use of growth factors, transfusion support allowed).
Disqualifiers
1. Having undergone ≥2 allo-HSCT procedures.
2. SR-aGVHD occurring after unplanned donor lymphocyte infusion (DLI) used for prophylactic treatment of malignancy relapse. *Note: Patients receiving planned DLI as part of the transplant procedure, not intended for managing malignancy relapse, may be included.*
3. Concurrent treatment with other JAK inhibitors.
4. Presence of active bleeding.
Trial design
Treatments tested in this trial
- Gecacitinib-Corticosteroid
- Methylprednisolone sodium succinate
Treatment groups
25 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Bin Gu
Lead sponsor
The First Affiliated Hospital of Soochow University
Sponsor institution
Source ClinicalTrials.gov