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

ConditionaGVHD

Trial statusRecruiting

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

Gecacitinib-Corticosteroid
Drug
Gecacitinib po. 50mg bid at least 28 days
Methylprednisolone sodium succinate
Drug
Methylprednisolone sodium succinate IV 2mg/kg/d.

Treatment groups

25 Participants

are divided into 1 treatment group

Group A: Treatment groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Overall 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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bin Gu

Lead sponsor

The First Affiliated Hospital of Soochow University

Sponsor institution

Source ClinicalTrials.gov

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