Steroid-Refractory acute graft versus host disease (aGVHD)
Conditions
Interventions
Placebo group:Saline treatment
Sponsors
The First Medical Center of the PLA General Hospital
Eligibility
Sex/Gender
All
Age
13 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age 13-70 years (including 13 and 70 years), either gender; 2. Patients with grade II to IV aGVHD after allogeneic hematopoietic stem cell transplantation for malignant hematologic disease, who failed to receive standard first-line glucocorticoid therapy; Specific definition of standard first-line glucocorticoid therapy: methylprednisolone 1mg/kg/day or 2mg/kg/day, or equivalent steroid dose; Failure of standard first-line corticosteroid therapy is defined as one of the following: Glucocorticoid-resistant: aGVHD progressed after 3 days of first-line glucocorticoid treatment, or aGVHD did not improve after 7 days of treatment, or aGVHD did not complete remission after 14 days of treatment; Glucocorticoid-dependent: the first-line treatment of glucocorticoid can not be reduced or the process of reduction of aGVHD reactivation; "Clinical manifestations of aGVHD are rash and/or persistent nausea, vomiting, and/or diarrhea, and/or cholestasis, for which alternative etiologies such as drug eruption, intestinal infection, or hepatotoxic syndrome have been ruled out." 3. Patients must receive investigational products within 3 days of enrollment; 4. The subjects must give their informed consent for this study before the trial, and the subjects or their legal guardians (only applicable to subjects < 18 years old) voluntarily sign the written informed consent form.
Exclusion criteria
Exclusion criteria: 1. The patient has lung disease, which is judged by the investigator to be unsuitable for participation in the investigator; 2. Positive serum virological tests for hepatitis C virus (HCV) antibodies, Treponema pallidum (TP) antibodies, or human immunodeficiency virus (HIV) antibodies; 3. Patients with severe hepatic veno-occlusive disease or sinusoidal occlusive syndrome; 4. Patients with aGVHD after receiving donor lymphocyte infusion for hematological relapse of underlying hematologic malignancy; 5. After aGVHD, changes in mental status can be diagnosed as brain lesions or other causes cannot be excluded; 6. For patients with aGVHD mainly with gastrointestinal symptoms, patients with cytomegalovirus (CMV) enteritis, transplant-associated thrombotic microangiopathy (TA-TMA) and diarrhea caused by gastrointestinal infection cannot be clinically excluded as assessed by the investigator; The pathological diagnostic criteria of CMV enteritis were: large cells with basophilic inclusion bodies in the intestinal mucosa; CMV early/late antigen positive by immunohistochemistry; CMV nucleic acid PCR was positive in intestinal mucosa homogenate; 7. Renal function of patients: creatinine clearance 3; 9. Patients with evidence of other diseases or physiological conditions that may interfere with the evaluation results of this trial within 6 months prior to enrollment, or severe life-threatening complications, including but not limited to uncontrolled infection, pulmonary hypertension, severe cardiac insufficiency (NYHA Class III and IV), unstable angina or acute myocardial infarction, refractory hypertension (defined as concurrent use of three different types of antihypertensive drugs [one of which is diuretic], blood pressure still higher than 180/110 mmHg) (based on the diagnosis in hospital records); 10. Patients with active malignant solid tumors within 5 years before the study, except for curatively treated cervical cancer, localized prostate cancer in situ and non-melanoma skin cancer; 11. Suffering from mental and neurological diseases and unable to express their wishes correctly; 12. Received = 1 treatment for aGVHD other than hormone before the study; 13. Known history of severe allergy to blood components or blood products, or history of allergy to heterologous proteins; 14. Breast-feeding women, or female patients who have a pregnancy plan or egg donation plan from the start of the study to the follow-up visit, and male patients (or their partners) who have a fertility plan or sperm donation plan from the start of the study to the follow-up visit, and are unwilling to take contraceptive measures; 15. Those who are not suitable to participate in the clinical trial as judged by the investigator; 16. Participation in other clinical trials within 1 month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate (ORR) at Day 28; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete response rate (CR) at Day 28;Overall response rate (ORR) at Day 56;Complete response rate (CR) at Day 56;Overall survival;Patient Functional Status Score (ECOG scoring criteria);28-day durable complete response rate; | — |
Countries
China
Contacts
Public ContactHou xiaoqiang
Platinumlife Biotechnology (Beijing) Co., Ltd.
Outcome results
None listed