Actively Recruiting
Evaluation of Recombinant Humanized Anti-CD25 Monoclonal Antibody to Prevent Graft-versus-host Disease After Haploidentical or Matched Unrelated Donor Hematopoietic Stem Cell Transplantation in Transfusion-dependent Thalassemia
Led by Rongrong Liu · Updated on 2024-10-28
396
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of recombinant humanized anti-CD25 monoclonal antibody to prevent graft-versus-host disease (GVHD) in patients with transfusion-dependent thalassemia undergoing haploidentical or matched unrelated donor hematopoietic stem cell transplantation. GVHD is a major complication that affects the success and quality of life after transplantation. This Phase 2 trial aims to determine whether this antibody reduces GVHD incidence and to assess its safety and impact on quality of life over a two-year follow-up. Participants will be randomly assigned in a 2:1 ratio to either receive the recombinant humanized anti-CD25 monoclonal antibody combined with standard GVHD prevention or standard prevention alone. The antibody is given in four doses at 1 mg/kg on days +7, +14, +28, and +42 after transplantation. The control group will not receive the antibody but will follow the usual GVHD prophylaxis. The study compares outcomes between these two groups. During the study, participants will be monitored for acute GVHD within 100 days and chronic GVHD, overall survival, thalassemia-free survival, transplant-related mortality, complications, infections, immune recovery, quality of life, and adverse events over two years. Regular assessments and follow-ups will evaluate the clinical efficacy and safety of the antibody treatment. The total participation time covers at least two years of follow-up after transplantation.
CONDITIONS
Brief 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
- Planning to receive matched unrelated donor or haploidentical hematopoietic stem cell transplantation
- Physical condition score (Lansky/Karnofsky) of 70% or higher
- Patients or legal guardians willing to participate and able to sign informed consent
You will not qualify if you...
- Patients with HLA-matched hematopoietic stem cell donors planning to receive matched transplantation
- Known infections such as hepatitis B, hepatitis C, AIDS, syphilis, or human T-lymphotropic virus
- Serious active bacterial, viral, fungal, malaria, or parasitic infections
- Autoimmune deficiency diseases
- History or current diagnosis of malignant tumors
- Significant organ diseases or abnormal lab tests including liver, heart, kidney, or endocrine disorders
- Uncorrected bleeding disorders
- Severe mental illness or cognitive dysfunction preventing cooperation
- Low white blood cell count (<3×10^9/L) or platelet count (<100×10^9/L)
- Thalidomide treatment within past 3 months
- Previous gene or cell therapy
- Severe allergies
- Female patients who are pregnant, breastfeeding, or planning pregnancy within 1 year
- Participation in other clinical trials
- Other conditions making participation unsuitable as assessed by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 weeks
Participants receive 4 doses of recombinant humanized anti-CD25 monoclonal antibody on days +7, +14, +28, and +42 after transplantation, or no treatment if in the control group.
4 visits (in-person) for dosing
Duration - Up to 2 years
Participants are monitored for graft-versus-host disease, survival, complications, immune reconstitution, quality of life, and adverse events for up to 2 years after transplantation.
Periodic visits over 2 years
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
Actively Recruiting
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Frequently Asked Questions
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