First-Line Jaktinib for Acute Graft-Versus-Host Disease (aGVHD)
China35 participantsStarted 2025-12-03
Plain-language summary
This study aims to evaluate the optimal dose (Recommended Phase 2 Dose, RP2D), preliminary safety, and efficacy of gecacitinib (also known as jaktinib) in combination with glucocorticoids as first-line therapy for patients with grade II-IV acute graft-versus-host disease (aGVHD) following allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Voluntarily provide signed informed consent and be ≥18 years of age at the time of consent.
✓. Recipients of allogeneic hematopoietic stem cell transplantation (allo-HSCT) using bone marrow, peripheral blood stem cells, or umbilical cord blood.
✓. Have received systemic glucocorticoid therapy for no more than 2 days prior to enrollment.
✓. Demonstrate clear myeloid and platelet engraftment: absolute neutrophil count (ANC) \> 1.0 × 10⁹/L and platelet count \> 50 × 10⁹/L (permitted use of growth factors or transfusion support).
✓. Clinical diagnosis of grade II-IV acute GVHD (aGVHD) per the MAGIC (Mount Sinai Acute GVHD International Consortium) criteria (Appendix 1).
✓. ECOG performance status of 0-2.
✓. Life expectancy \> 4 weeks.
✓. Able to swallow tablets.
Exclusion criteria
✕. History of ≥2 allo-HSCT procedures.
✕. Development of aGVHD following unplanned donor lymphocyte infusion (DLI) for relapse of underlying malignancy. Note: Planned DLI as part of the transplant protocol is permitted.
✕. Concurrent treatment with another JAK inhibitor. Note: Patients who previously discontinued JAK inhibitors due to toxicity (not refractory aGVHD) are eligible.
✕
What they're measuring
1
Incidence of Adverse Reactions by Dosage Group in Patients with Grade II-IV Acute GVHD Treated with First-Line Gecacitinib (also known as Jaktinib) and corticosteroids
Timeframe: 28 days
2
The Day 28 Overall Response Rate (ORR) in patients with grade II-IV acute graft-versus-host disease (GVHD) treated with Ggecacitinib (also known as Jaktinib) in combination with corticosteroids as first-line therapy.
Timeframe: 28 days
Trial details
NCT IDNCT07285889
SponsorFirst Affiliated Hospital of Zhejiang University
✕. Uncontrolled active infection, defined as sepsis-induced hemodynamic instability or progressive symptoms/signs/imaging findings attributable to infection. Asymptomatic or persistent fever alone is not exclusionary.
✕. unresolved toxicity or complications from allo-HSCT (excluding aGVHD).
✕. Clinically significant abnormalities that may compromise safety, including: a) Uncontrolled diabetes (fasting glucose \>13.9 mmol/L); b) Hypertension unresponsive to ≥2 agents (systolic BP ≥160 mmHg or diastolic BP ≥100 mmHg); c) Peripheral neuropathy ≥Grade 2 (per NCI CTCAE v5.0).