Steroid-Refractory/dependent cGVHD
Conditions
Interventions
Experimental group:Oral artesunate tablets
Sponsors
The Second Affiliated Hospital of the Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. The subjects were aged between 18 and 60 years old, and had received allogeneic hematopoietic stem cell transplantation (allo-HSCT), with no restrictions on gender. 2. The subjects included in this study were all in accordance with the diagnostic criteria for hormone-resistant cGVHD disease as determined by this research. Specifically, they met the following conditions: prednisone >= 1mg/kg/d for 1-2 weeks, with continued symptom progression; or prednisone 0.5mg/kg/d (or 1mg/kg/d every other day) for at least 4 weeks, with cGVHD remaining in a stable state; or prednisone > 0.25mg/kg/d (or > 0.5mg/kg/d every other day), and at least two attempts to reduce the dose to a lower level with an interval of = 8 weeks, but none of these attempts were successful. 3. The underlying condition is stable, with no progression or recurrence. 4. ECOG score: 0 to 2; 5. Obtain the informed consent of the patients and their families, and have them voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Anyone who is allergic to any component of the drug under study; 2. Patients with post-transplant lymphoproliferative disorders; 3. Before initiating the second-line treatment, there is pathological evidence confirming the recurrence of the disease in the patient, or the clinical physician deems it inappropriate to continue the anti-rejection treatment for other reasons. 4. There is evidence of active and uncontrolled viral infections such as CMV, EBV, HIV, HHV-6, HBV (with positive HBsAg and positive HBV-DNA and >= 2000 IU/ml or 104 copies/mL), HCV (with positive anti-HCV antibody or HCV-RNA), BK virus, etc., or any clinical symptoms of bacterial, viral, parasitic or fungal infections that require treatment; those who had a history of active tuberculosis within the previous 6 months; 5. Patients who have suffered from other malignant tumors and are currently undergoing treatment, or who have previously been diagnosed with other malignant tumors within the past 5 years; 6. Severe cardiovascular diseases (patients with uncontrolled arrhythmia requiring treatment, those with a QTc interval (QTcB) > 480ms, congestive heart failure, NYHA class III or IV, or symptomatic ischemic heart disease); 7. Other situations deemed unsuitable for inclusion in the study by the researchers include: patients who underwent surgery within the previous 4 weeks and have not fully recovered; patients screened who have epilepsy or are using psychotropic or sedative drugs; diabetes that is not controlled by medication (fasting blood glucose > 8.9 mmol/L); hypertension patients whose blood pressure cannot be reduced to the following range after treatment with two or fewer antihypertensive drugs (systolic blood pressure 2.5×ULN; DBIL and TBIL > 2.0×ULN; serum creatinine > 1.5×ULN; patients using anticoagulant or platelet function drugs (except low molecular weight heparin); patients who used Chinese herbal medicines including ephedra, ginkgo, saw palmetto and ginseng within one week before enrollment; 8. Pregnant or lactating patients; 9. Unable to complete the research as required by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in tear film break-up time;Corneal fluorescein staining score;Variation in the height of the tear river;Overall survival at 6 months;Ocular Surface Disease Index (OSDI) score;NIH Eye Score;Schirmer Test ?;Lymphocyte subsets;Severity and incidence of adverse events;The proportion of artemether use discontinued due to toxicity or intolerance;Observation of changes in corneal epithelial cells, endothelial cells, corneal basal nerve, and inflammatory cells under confocal microscopy (IVCM);Incidence of infection; | — |
Countries
China
Contacts
Public ContactZhang Xi
The Second Affiliated Hospital of the Army Medical University
Outcome results
None listed