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Evaluation of Recombinant Humanized Anti-CD25 Monoclonal Antibody for Preventing Graft-versus-host Disease After Haploidentical/matched Unrelated Donor Hematopoietic Stem Cell Transplantation in Patients with Transfusion-dependent Thalassemia
Led by Rongrong Liu · Updated on 2024-10-28
396
Participants Needed
5
Research Sites
156 weeks
Total Duration
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AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of Recombinant Humanized Anti-CD25 Monoclonal Antibody for Preventing Graft-versus-host Disease After Haploidentical/matched Unrelated Donor Hematopoietic Stem Cell Transplantation in Patients with Transfusion-dependent Thalassemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with transfusion-dependent thalassemia
- Patients planning to receive matched unrelated donor or haploidentical donor hematopoietic stem cell transplantation
- Physical condition score (Lansky or Karnofsky) of 70% or higher
- Patients or legal guardians able and willing to sign informed consent
You will not qualify if you...
- Patients with HLA-matched hematopoietic stem cell donors willing to receive matched donor transplantation
- Patients with known infectious diseases such as hepatitis B, hepatitis C, AIDS, syphilis, or human T-lymphotropic virus
- Patients with serious active bacterial, viral, fungal, malaria, or parasitic infections
- Patients with autoimmune deficiency diseases
- Patients with history of or current malignant tumors
- Patients with important organ diseases or abnormal lab tests, including liver disease, heart disease, kidney disease, or endocrine dysfunction
- Patients with uncorrected bleeding disorders
- Patients with severe mental illness or cognitive dysfunction preventing study cooperation
- Peripheral blood white blood cell count less than 3x10^9/L or platelet count less than 100x10^9/L
- Patients treated with thalidomide within past 3 months
- Patients who previously received any gene or cell therapy
- Patients with severe allergies
- Female patients who are pregnant, breastfeeding, or planning pregnancy within 1 year
- Patients currently participating in other clinical trials
- Any other condition the investigator considers unsuitable for participation
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Maoming People's Hospital
Maoming, Guangdong, China, 525000
Actively Recruiting
2
Liuzhou Workers' Hospital
Liuzhou, Guangxi, China, 545007
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3
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530000
Actively Recruiting
4
Yulin Red Cross Hospital
Yulin, Guangxi, China, 537000
Actively Recruiting
5
Hainan Provincial People's Hospital
Haikou, Hainan, China, 570000
Actively Recruiting
Research Team
R
Rongrong Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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