Phase
Condition
Thalassemia
Treatment
recombinant humanized anti-CD25 monoclonal antibody
Clinical Study ID
Ages 3-20 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
patients with transfusion-dependent thalassemia;
patients who are planning to receive matched unrelated donor hematopoietic stem celltransplantation (MUD-HSCT) or HLA haploidentical donor hematopoietic stem celltransplantation (HID-HSCT);
physical condition score (Lansky/Karnofsky score) ≥ 70%;
patients (or legal guardians) voluntarily participate in the study and sign theinformed consent form
Exclusion
Exclusion Criteria:
patients with HLA-matched hematopoietic stem cell donors and willing to receiveHLA-matched hematopoietic stem cell transplantation;
patients with known infectious diseases such as hepatitis B, hepatitis C, AIDS,syphilis, human T-lymphotropic virus, etc.;
patients with serious active bacterial, viral, fungal, malaria or parasiticinfections;
patients with autoimmune deficiency diseases;
patients with a history of malignant tumors or current malignant tumors;
patients with important organ diseases or abnormal laboratory tests, including butnot limited to: 1) patients with cirrhosis, liver fibrosis or active hepatitis,and/or abnormal liver function tests (alanine aminotransferase (ALT) and aspartateaminotransferase (AST) ≥2.5×ULN; alkaline phosphatase ≥2.5×ULN); 2) patients withheart disease, or left ventricular ejection fraction (LVEF) <60%, or severe irondeposition in the heart; 3) kidney disease, or blood creatinine ≥1.5×ULN withcreatinine clearance <30% of normal level; 4) patients with endocrine dysfunction;
patients with uncorrected bleeding disease;
patients with severe mental illness (such as severe depression, schizophrenia, etc.)or cognitive dysfunction (dementia, delirium, etc.), which are unable to cooperatewith the study;
peripheral blood white blood cell (WBC) count <3×10^9/L or platelet count <100×10^9/L;
patients having received thalidomide treatment within the past 3 months;
patients having received any type of gene and/or cell therapy in the past;
patients with severe allergies;
female patients who are pregnant, breastfeeding, or planning to become pregnantwithin 1 year of participating in this trial;
patients who are participating in other clinical trials;
other situations that are not suitable for participation in this clinical trial asassessed by the investigator.
Study Design
Connect with a study center
Maoming People's Hospital
Maoming, Guangdong 525000
ChinaActive - Recruiting
Liuzhou Workers' Hospital
Liuzhou, Guangxi 545007
ChinaActive - Recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi 530000
ChinaActive - Recruiting
Yulin Red Cross Hospital
Yulin, Guangxi 537000
ChinaActive - Recruiting
Hainan Provincial People's Hospital
Haikou, Hainan 570000
ChinaActive - Recruiting
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