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 was 150mg/day (dose was adjusted according to dru
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) The underlying disease was stable, no progression and no recurrence; (5) ECOG score 0~2; (6) Each subject (or legally acceptable representative) voluntarily joined the study and signed informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients who are allergic to JAK1 inhibitors or their excipients; (2) There are many factors affecting oral drugs (such as inability to swallow, chronic diarrhea and intestinal obstruction); (3) Before the initiation of treatment, there was pathological evidence to confirm the recurrence of the disease or other factors. Clinicians judged that it was not appropriate to continue to receive anti-rejection therapy; (4) Patients had uncontrollable active infection; (5) Have received JAK1 inhibitor treatment (including prevention or treatment of acute GVHD); (6) Complicated with other malignant tumors and undergoing 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 that are not suitable for inclusion in the study are judged by the researchers; (10) unable to tolerate prednisone 1mg/kg/d or equivalent dose of other steroids in the treatment of cGVHD; (11) Previously received any systemic treatment for cGVHD, except for the administration of hormones for cGVHD within 72 hours before enrollment; (12) Patients who were pregnant or had been 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