Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-25 @ 2:05 AM
NCT ID:
NCT05152160
Eligibility Criteria:
Inclusion Criteria:
1. Age 14-70 (≥14, ≤70) one year old, no gender limit;
2. The subject voluntarily participates in the study, and he or his legal guardian signs the "Informed Consent";
3. CGVHD occurred after transplantation of allogeneic hematopoietic stem cells (umbilical cord blood, bone marrow or mobilized peripheral blood) with the primary disease of hematological malignancy, and was diagnosed as moderate/severe cGVHD according to the "Chinese Expert Consensus on the Diagnosis and Treatment of cGVHD (2021 Edition)";
4. Those who are tolerant to the first-line standard treatment regimen (glucocorticoid with or without calcineurin inhibitor):
1\) The organ damage that has been involved in the past is aggravated; 2) People with new organ involvement; 3) No improvement in symptoms and signs after 1 month of regular medication (such as glucocorticoid therapy alone, progress in the initial 2 weeks, no improvement in 6-8 weeks, consider glucocorticoid resistance); 4) At 2 months, prednisone cannot be reduced to less than 1.0mg/kg/d; 5. EOCG score ≤ 3 points.
Exclusion Criteria:
\-
Patients with any of the following cannot be included in this study:
1. Serum virological examination showed that hepatitis C virus (HCV) antibody, Treponema pallidum (TP) antibody or human immunodeficiency virus (HIV) antibody test results were positive;
2. People with severe hepatic vein occlusive disease or sinus vein occlusive syndrome;
3. According to the evaluation of the investigator, patients with cytomegalovirus (CMV) enteritis, transplantation-related thrombotic microangiopathy (TA-TMA), and gastrointestinal infections caused by diarrhea cannot be ruled out clinically; the pathological diagnosis criteria of CMV enteritis are: intestinal mucosa. Large cells of basic inclusion bodies, immunohistochemical CMV early/late antigen positive, intestinal mucosal homogenate CMV nucleic acid PCR positive;
4. Patient renal function: creatinine clearance rate \<30mL/min; creatinine clearance rate is calculated by Cockcroft-Gault formula: Ccr(ml/min)=\[(140-age)×weight (kg)\]/(72×serum creatinine( mg/dL), for women, according to the calculation result × 0.85), the unit of creatinine should be paid attention to during the calculation of creatinine clearance;
5. Within 6 months before enrollment, there is evidence that the patient has other diseases or their physiological conditions may interfere with the evaluation results of this test, or the complications are severely life-threatening, including but not limited to uncontrolled infections, pulmonary hypertension, severe Cardiac insufficiency (NYHA class III and IV), unstable angina or acute myocardial infarction, refractory hypertension (defined as the simultaneous use of 3 different types of antihypertensive drugs \[one of which is a diuretic\] Higher than 180/110mmHg) (subject to the diagnosis of hospitalized medical records), etc.;
6. Patients with active malignant solid tumors within the first 5 years of the study, except for radically cured cervical cancer, in situ localized prostate cancer and non-melanoma skin cancer;
7. Patients with myelofibrosis;
8. People who suffer from mental or neurological diseases and cannot express their wishes correctly;
9. Those who have a history of severe allergies to blood components or blood products, or those who have a history of allergies to heterologous proteins;
10. Breastfeeding women, or female patients who have pregnancy plans or egg donation plans from the start of the study to the follow-up period, and male patients (or their partners) have birth plans or sperm donation plans from the start of the study to the follow-up period, and are unwilling to take contraceptive measures ；
11. Those determined by the investigator to be unsuitable to participate in this clinical trial;
12. Those who have participated in other clinical trials within the previous month.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
70 Years
Study:
NCT05152160
Study Brief:
Protocol Section:
NCT05152160