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.
NCT Number: NCT06657391
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.
Interested in participating?
Request Info3 year–20 year
All sexes
Interventional
Phase 2
Maoming People's Hospital, Maoming, Guangdong, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The 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.
Time frame: within 100 days after HID-HSCT/MUD-HSCT
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.
Time frame: within 100 days after HID-HSCT/MUD-HSCT
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.
Time frame: 2 years
The incidence of cGVHD after HID-HSCT/MUD-HSCT was compared between the intervention group and the control group.
Time frame: 2 years
Comparison of 2-year OS between the intervention group and the control group.
Time frame: 2 years
comparison of the 2-year TFS between the intervention group and the control group.
Time frame: 2 years
comparison of the 2-year TRM between the intervention group and the control group.
Time frame: 2 years
comparison of the 2-year transplantation-related complications between the intervention group and the control group.
Time frame: 2 years
comparison of the infection during the transplantation between the intervention group and the control group.
Time frame: 2 years
comparison of the immune reconstitution after transplantation between the intervention group and the control group.
Time frame: 2 years
comparison of the quality of life between the intervention group and the control group by using the Pediatric Quality of Life Inventory Version 4.0 (PedsQL4.0) scale. The scales are comprissed of parallel self-report and parent proxy-report formats:
A 5-point response scale is utilized across self-report for ages and parent proxy-report (0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem). Items are reverse-scored and linearly transformed to a 0 to 100 scale (0 = 100, 1 = 75, 2 = 50, 3 =25, 4 = 0), so that higher scores indicate better health-related quality of life.
Time frame: 2 years
comparison of the occurrence of adverse events between the intervention group and the control group.
Contact information is provided by the study sponsor or research team.
Rongrong Liu
Other
Evaluation of the Clinical Efficacy and Safety of Recombinant Humanized Anti-CD25 Monoclonal Antibody in Preventing Graft-versus-host Disease After Haploidentical / Matched Unrelated Donor Hematopoietic Stem Cell Transplantation in Patients with Transfusion-dependent Thalassemia: a Prospective, Multicenter, Open-label, Randomized Controlled Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.