Chronic Graft-Versus-Host Disease (cGVHD)
Conditions
Interventions
Experimental group:Jaktinib Hydrochloride
Sponsors
The Second Affiliated Hospital of the Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years old, =1mg/kg/ day for 1-2 weeks with progressive symptoms, or prednisone 0.5mg/kg/ day (or 1mg/kg/ day every other day) for at least 4 weeks with stable cGVHD. 2) steroid-dependent cGVHD: prednisone >0.25mg/kg/ day (or >0.5mg/kg/ day every other day) to prevent the recurrence or progression of symptoms, with at least two attempts to reduce the dose to a lower level with an interval of >=8 weeks, but without success; 3) patients had contraindications to or refused standard treatment; (2) Recurrent cGVHD was defined as symptomatic active disease (response to prior treatment) defined by organ-specific or global assessment, or a need for initiation of new systemic therapy as deemed by the investigator; 4. Stable underlying disease without progression or recurrence; 5. ECOG score 0-2; 6. Each subject (or legally acceptable representative) volunteered to participate in the study and provided written informed consent
Exclusion criteria
Exclusion criteria: 1.Suspected allergy to Jicagrelatin hydrochloride, similar drugs, or any of their excipients; 2.Patients with factors affecting oral drug administration (e.g., gastrointestinal dysfunction or disorders impacting drug absorption, such as inability to swallow, small bowel resection, peptic ulcer disease, nausea, vomiting, or diarrhea >3 times/day, intestinal obstruction, etc.); 3.Patients with pathological evidence of disease relapse before initiation of second-line therapy, or as judged by the clinician, not suitable to continue anti-GVHD therapy due to other reasons; 4.Presence of active and uncontrolled viral infections, such as evidence of CMV, EBV, HIV, HHV-6, HBV (HBsAg-positive, HBV-DNA positive with =2,000 IU/mL or 1×104 copies/mL), HCV (anti-HCV antibody or HCV-RNA positive), BK virus, or any clinical symptoms of bacterial, viral, parasitic, or fungal infections requiring treatment; history of active tuberculosis within 6 months prior to screening; 5.Prior treatment with JAK/ACVR1 inhibitors (including for prevention or treatment of acute GVHD); 6.Concomitant other malignancies under treatment, or any other malignancy within the past 5 years; 7.Severe cardiovascular diseases (uncontrolled arrhythmias requiring treatment, QTc interval [QTcB] >480 ms, congestive heart failure, NYHA class III or IV, or symptomatic ischemic heart disease); 8.Increased or reduced immunosuppressive therapy within 4 weeks prior to treatment; 9.Other conditions deemed unsuitable for study entry by the investigator, including: patients who underwent surgical procedures within the previous 4 weeks but have not fully recovered; patients who have epilepsy or are using psychotropic or sedative medications at screening; patients with diabetes mellitus that cannot be controlled by medication (fasting blood glucose >8.9 mmol/L); patients with hypertension that cannot be controlled to below the following range by treatment with two or fewer antihypertensive agents (systolic BP 2.5×ULN; DBIL or TBIL >2.0×ULN; serum creatinine >1.5×ULN; use of anticoagulant or antiplatelet drugs (except low-molecular-weight heparin); use of herbal medicines such as ephedra, ginkgo, saw palmetto, or ginseng within 1 week before enrollment; 10.Breastfeeding women, patients unwilling to use effective contraception during the study and within 4 weeks after the last dose, and pregnant patients; 11.Participation in another investigational drug or medical device clinical trial within 12 weeks prior to screening, or infusion of donor lymphocytes, CAR-T, or CAR-NK cells within 30 days prior to enrollment; 12.Any other condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the study. 13.Patients with post-transplant lymphoproliferative disorder;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| One year survival after transplantation;Nonrelapse mortality and relapse at 1 year after transplantation;Changes in hormone doses from baseline in the trial group;Incidence of infection;Proportion of JAK/ACVR1 inhibitors discontinued due to toxicity or intolerance;SF-36 quality of life scale was used at 3, 6, and 12 months after treatment;The severity and incidence of adverse events according to CTCAE, version 5.0; | — |
Countries
China
Contacts
Public ContactZhang Xi
The Second Affiliated Hospital of the Army Medical University
Outcome results
None listed