Steroid-Refractory /dependent cGVHD
Conditions
Interventions
Experimental group:Treated with PI3Kd inhibitor (linplixab 40-80 mg/d) for a 28-day cycle for a total of 6 cycles. The dose of linpulisab was adjusted according to the change in cGVHD disease and drug
Control group:There are three commonly used treatment regimens for SR-cGVHD, which are selected according to the patients condition, including imatinib, calcineurin inhibitor (CNI), and mTOR inhibitor
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, = 1mg/kg/d for 1-2 weeks, still progressed, or prednisone 0.5mg/kg/d ( or 1mg/kg/d every other day ) for at least 4 weeks, cGVHD remained stable. b.Steroid-dependent cGVHD : prednisone > 0.25mg/kg/d ( or > 0.5mg/kg/d every other day ) can prevent the recurrence or progression of symptoms. At least two attempts to reduce the dose to a lower level and the interval = 8 weeks were unsuccessful; c. Patients have contraindications to standard treatment or refuse to accept standard treatment; 2 ) Recurrent cGVHD is defined as : symptomatic active disease defined by organ-specific or overall assessment ( remission after previous treatment ), or researchers believe that new systemic treatment needs to be initiated; ( 4 ) The underlying disease was stable, no progression and no recurrence; ( 5 ) ECOG score 0 ~ 2; ( 6 ) Each subject ( or legally acceptable representative ) volunteered to participate in the study and signed informed consent.
Exclusion criteria
Exclusion criteria: ( 1 ) Patients who were allergic to PI3K inhibitors or their excipients; ( 2 ) There are many factors affecting oral drugs ( such as inability to swallow, chronic diarrhea and intestinal obstruction ); ( 3 ) Before initiating the second-line 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 currently have uncontrolled active infection; ( 5 ) Have received PI3K inhibitor treatment ( including the 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 ) Increase or decrease immunosuppression within 4 weeks before treatment; ( 10 ) Other situations judged by the researcher to be unsuitable for inclusion in the study; ( 11 ) Patients who were pregnant or had been pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate after 6 months of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-year overall survival;1-year non-relapse mortality;Lymphocyte subsets;Adverse Events;Incidence of infection;Proportion of PI3K 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 University )
Outcome results
None listed