Graft-versus-host disease (GVHD) is a major factor affecting the efficacy and quality of life of alternative donor transplantation in thalassemia major (TM), severely limiting the clinical application of alternative donor transplantation in TM.The purpose of this clinical trial is to evaluate whether recombinant humanized anti-CD25 monoclonal antibody is effective in preventing GVHD and its safety after haploidentical/matched unrelated donor hematopoietic stem cell transplantation. The main questions it aims to answer are:
* Does recombinant humanized anti-CD25 monoclonal antibody reduce the incidence of GVHD disease after haploidentical/matched unrelated donor hematopoietic stem cell transplantation? * What medical problems will participants experience when using the recombinant humanized anti-CD25 monoclonal antibody? What is the quality of life after 2 years follow-up? In this clinical trail, participants will be randomly assigned to the intervention group or the control group by researchers in a 2:1 ratio. The intervention group will be given recombinant humanized anti-CD25 monoclonal antibody (1mg/Kg) combined with the standard GVHD prophylaxis after transplantation, while the control group will only receive the standard GVHD prophylaxis. The incidence of GVHD after transplantation in the two groups will be observed. The main evaluation is the clinical efficacy of recombinant humanized anti-CD25 monoclonal antibody in preventing aGVHD.
patients with transfusion-dependent thalassemia;
patients who are planning to receive matched unrelated donor hematopoietic stem cell transplantation (MUD-HSCT) or HLA haploidentical donor hematopoietic stem cell transplantation (HID-HSCT);
physical condition score (Lansky/Karnofsky score) ≥ 70%;
patients (or legal guardians) voluntarily participate in the study and sign the informed consent form
patients with HLA-matched hematopoietic stem cell donors and willing to receive HLA-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 parasitic infections;
patients with autoimmune deficiency diseases;
Parallel
recombinant humanized anti-CD25 monoclonal antibody
DrugThe intervention group received 4 doses of recombinant humanized anti-CD25 monoclonal antibody on days +7, +14, +28, and +42 after transplantation, with a recommended dose of 1 mg/kg.
Grade III-IV aGVHD
the incidence of grade III-IV aGVHD within 100 days after HID-HSCT/MUD-HSCT was compared between the intervention group and the control group.
Grade II-IV aGVHD
the incidence of grade II-IV aGVHD within 100 days after HID-HSCT/MUD-HSCT was compared between the intervention group and the control group.
Chronic graft-versus-host disease (cGVHD)
The incidence of cGVHD after HID-HSCT/MUD-HSCT was compared between the intervention group and the control group.
Overall survival (OS)
Comparison of 2-year OS between the intervention group and the control group.
Thalassemia-free survival (TFS)
comparison of the 2-year TFS between the intervention group and the control group.
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Rongrong Liu
Lead sponsor
First Affiliated Hospital of Guangxi Medical University
Sponsor institution
