Not Yet RecruitingPhase 2

Study of Gecacitinib in the Treatment of Acute Graft-Versus-Host Disease After Failure of Ruxolitinib-containing Second-line Therapy

15 participantsStarted 2025-10-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Voluntarily signed the informed consent form, with age ≥18 years at the time of ICF signing;
✓. Recipients who have undergone non-myeloablative, myeloablative, or reduced-intensity allo-HSCT (allogeneic hematopoietic stem cell transplantation) from any donor source (matched unrelated donor, sibling, or haploidentical) using bone marrow, peripheral blood stem cells, or umbilical cord blood;
✓. Complete donor engraftment: donor STR ≥95%, peripheral blood absolute neutrophil count (ANC) \>0.5×10⁹/L, platelet count \>25×10⁹/L (use of growth factors, transfusion support, etc., is permitted);
✓. aGVHD patients who have failed second-line treatment including ruxolitinib, defined as follows:
✓. ECOG score: 0-2;
✓. Expected survival greater than 4 weeks;
✓. Ability to swallow tablets;
✓. Ability to comply with study and follow-up procedures.

Exclusion criteria

✕. Patients who have undergone ≥2 allo-HSCT procedures;
✕. Development of SR-aGVHD following unplanned donor lymphocyte infusion (DLI) administered for the treatment of malignant relapse. Note: Patients who received planned DLI as part of the transplant procedure, not intended for managing malignant relapse, may be enrolled;
✕. Prior use of ruxolitinib in combination with \>1 systemic therapy for steroid-refractory aGVHD;
✕. Concurrent use of other JAK inhibitors besides ruxolitinib for treatment. Patients who discontinued JAK inhibitor therapy for aGVHD due to side effects rather than refractoriness are also eligible for the study;
✕. Patients with active bleeding;
✕. Patients diagnosed with or suspected of having chronic GVHD;
✕. Presence of uncontrolled active infection. Uncontrolled active infection is defined as: hemodynamic instability due to sepsis, or worsening of symptoms, signs, or radiographic findings attributable to the infection. Persistent fever without symptoms or with resolving symptoms is not considered an uncontrolled active infection;
✕. Patients with unresolved toxicity or complications due to allo-HSCT (excluding aGVHD);

What they're measuring

Overall Response Rate

Timeframe: Within 28 days of first dose

Trial details

NCT IDNCT07197112

SponsorRuijin Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-02-01

Contact for this trial

Xiaoxia Hu, MD

+86 021-64370045 hu_xiaoxia@126.com

View on ClinicalTrials.gov More Acute Graft Versus Host Disease Grade II-IV trials