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

Launched by RONGRONG LIU · Oct 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called recombinant humanized anti-CD25 monoclonal antibody to see if it can help prevent a serious condition known as graft-versus-host disease (GVHD) after certain types of stem cell transplants in patients with transfusion-dependent thalassemia. GVHD can significantly impact recovery and quality of life, so the researchers want to find out if this new medication can reduce the chances of developing GVHD when combined with standard care after the transplant.

To participate in this trial, patients should be planning to receive a stem cell transplant from a matched unrelated donor or a family member. They should also be in good physical condition and able to provide consent. During the trial, participants will be randomly assigned to either receive the new treatment along with standard care or just the standard care alone. The researchers will monitor how well the treatment works and any side effects that may arise over a two-year period. This study is currently recruiting participants of all ages, and it aims to improve the safety and effectiveness of treatments for thalassemia patients undergoing stem cell transplantation.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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;
• • patients with a history of malignant tumors or current malignant tumors;
• • patients with important organ diseases or abnormal laboratory tests, including but not limited to: 1) patients with cirrhosis, liver fibrosis or active hepatitis, and/or abnormal liver function tests (alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥2.5×ULN; alkaline phosphatase ≥2.5×ULN); 2) patients with heart disease, or left ventricular ejection fraction (LVEF) \<60%, or severe iron deposition in the heart; 3) kidney disease, or blood creatinine ≥1.5×ULN with creatinine 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 cooperate with 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 pregnant within 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 as assessed by the investigator.