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

Last updated: October 24, 2024
Sponsor: Rongrong Liu
Overall Status: Active - Recruiting

Phase

2

Condition

Thalassemia

Treatment

recombinant humanized anti-CD25 monoclonal antibody

Clinical Study ID

NCT06657391
2024-K387-01
  • Ages 3-20
  • All Genders

Study Summary

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.

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

Total Participants: 396
Treatment Group(s): 1
Primary Treatment: recombinant humanized anti-CD25 monoclonal antibody
Phase: 2
Study Start date:
October 01, 2024
Estimated Completion Date:
September 30, 2027

Connect with a study center

  • Maoming People's Hospital

    Maoming, Guangdong 525000
    China

    Active - Recruiting

  • Liuzhou Workers' Hospital

    Liuzhou, Guangxi 545007
    China

    Active - Recruiting

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi 530000
    China

    Active - Recruiting

  • Yulin Red Cross Hospital

    Yulin, Guangxi 537000
    China

    Active - Recruiting

  • Hainan Provincial People's Hospital

    Haikou, Hainan 570000
    China

    Active - Recruiting

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