chronic graft-versus-host disease
Conditions
Interventions
treatment group:On the basis of conventional first-line treatment regimen prednisone ( equivalent ), golidocitinib was added. The dose of golidocitinib is 150 mg qod, and the dose can be adjusted to 1
Sponsors
The Second Affiliated Hospital of Army Medical University (Xinqiao Hospital of Army Medical University)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years old, =2 organs involved; 4. Stable underlying disease, no progression or recurrence; 5. ECOG score 0~2; 6. Each subject (or legally acceptable representative) voluntarily joins this study and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients who are allergic to JAK1 inhibitors or their excipients; 2. Having a variety of factors affecting oral drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.); 3. Before starting treatment, there is pathological evidence confirming that the patient has recurred or is judged by the clinician to be inappropriate to continue receiving anti-rejection therapy due to other factors; 4. The patient has uncontrollable active infection; 5. Have received JAK1 inhibitor therapy (including prevention or treatment of acute GVHD); 6. Combined with other malignant tumors and under treatment; 7. Severe cardiovascular disease (uncontrolled arrhythmia, congestive heart failure, NYHA III or IV, or symptomatic ischemic heart disease); 8. Infusion of donor lymphocytes or Car-T cells within the last 30 days; 9. Other situations judged by the investigator to be unsuitable for inclusion in the study; 10. Inability to tolerate prednisone 1mg/kg/d or equivalent dose of other hormones for cGVHD; 11. Previous systemic treatment for cGVHD, except for hormones for cGVHD within 72 hours prior to enrollment; 12. Patients who intend to become pregnant or have become pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate after 3 months of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-year overall survival;1-year non-relapse mortality;Lymphocyte subsets;Adverse Events;Proportion of JAK1 inhibitors discontinued due to toxicity or intolerance; | — |
Countries
China
Contacts
Public ContactZhang Xi
The Second Affiliated Hospital of Army Medical University (Xinqiao Hospital of Army Medical
Outcome results
None listed