Chronic Graft-Versus-Host Disease
Conditions
Interventions
Experimental Group:Basic immunosuppressive regimen+Gicalixitinib hydrochloride 50 mg twice daily
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily signs the Informed Consent Form (ICF) and is aged 18–65 years at the time of ICF signing; 2. Recipient who has undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT) (myeloablative, non-myeloablative, or reduced-intensity conditioning) using bone marrow, peripheral blood stem cells, or umbilical cord blood from any donor source (matched unrelated donor, sibling, or haploidentical donor); 3. Documented myeloid and platelet engraftment: absolute neutrophil count (ANC) > 0.5 × 10?/L and platelet count > 25 × 10?/L (growth factor support or blood transfusion is permitted); 4. Patient with a clinical diagnosis of chronic graft-versus-host disease (cGVHD) meeting the 2014 NIH Consensus Criteria, with specific standards as follows: Has at least one "diagnostic" manifestation of chronic GVHD; Has one "distinctive" manifestation of chronic GVHD plus the following auxiliary examinations (unless otherwise specified): histopathological biopsy of the affected organ, laboratory tests or other examinations (e.g., pulmonary function tests, Schirmer’s test), specialist evaluations (e.g., gynecological or ophthalmological examination), or radiological findings confirming chronic GVHD involvement in the current or other organs; 5. Patient with moderate to severe cGVHD meeting the 2014 NIH Consensus Criteria, with specific standards as follows: Moderate cGVHD: At least 1 organ (non-lung) with a score of 2, 3 or more organs each with a score of 1, or lung score of 1; Severe cGVHD: At least 1 organ with a score of 3, or lung score of 2 or 3; 6. Duration of glucocorticoid therapy for chronic GVHD = 4 weeks; 9. Ability to swallow tablets; 10. Willingness and ability to comply with study procedures and follow-up requirements.
Exclusion criteria
Exclusion criteria: 1. Patients who have received JAK inhibitor therapy after transplantation and failed treatment (patients with intolerance to JAK inhibitor toxicity are eligible for inclusion); 2. Known or suspected active acute graft-versus-host disease (aGVHD); 3. Diagnosis of post-transplant lymphoproliferative disorder (PTLD) or relapse of the original malignant hematological disease; 4. Any significant clinical or laboratory abnormalities that, in the investigator’s judgment, may affect safety assessment, such as: a) Hypertension uncontrolled (systolic blood pressure [SBP] >= 160 mmHg or diastolic blood pressure [DBP] >= 100 mmHg) despite treatment with 480 ms; 7. Pre-existing gastrointestinal dysfunction or diseases affecting drug absorption prior to study drug administration, such as small bowel resection, ulcerative disease, nausea/vomiting, or diarrhea = 3 episodes/day; 8. Patients who underwent major surgery within 4 weeks prior to study drug administration and have not yet fully recovered; 9. Evidence of active, uncontrolled viral infections prior to study drug administration (e.g., CMV, EBV, HIV, HHV-6, HBV [HBsAg positive with HBV-DNA >= 2000 IU/mL or 104 copies/mL], HCV [positive anti-HCV antibodies or HCV-RNA], BK virus), or active bacterial, viral, parasitic, or fungal infections with clinical symptoms requiring treatment; 10. Interstitial pneumonia, non-infectious pneumonia, uncontrolled active infection, or infection requiring systemic treatment within 7 days prior to study drug administration, except as deemed eligible by the investigator; 11. History of active tuberculosis within 6 months prior to study drug administration; 12. Patients with epilepsy or receiving psychotropic drugs or sedatives prior to study drug administration; 13. Lactating females, or subjects who refuse to use effective contraception during the study and for 4 weeks after the last dose of study drug; 14. Patients with a history of malignant tumors within the past 3 years (excluding the malignant hematological disease that led to stem cell transplantation, cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, radical resected ductal carcinoma in situ of the breast, and radical resected thyroid cancer); 15. Suspected hypersensitivity to gicitinib hydrochloride, similar drugs, or any of their excipients; 16. Participation in other clinical trials of new drugs or medical devices within 12 weeks prior to study drug administration; 17. Any other subjects deemed ineligible for participation in the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time for treatment to take effect;One-year recurrence rate;Overall survival rate;12-week objective response rate (ORR);Adverse event incidence;Best remission rate within 24 weeks;One-year failure-free survival rate;Cumulative dose of prednisone;Duration of effect;One-year non-recurrence mortality rate; | — |
Countries
China
Contacts
Public ContactZhilei Bian
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed