NCT06657391RecruitingPhase 2
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
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
Source: ClinicalTrials.gov · Last updated 28 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 396 (estimated)
- First submitted
- 21 Oct 2024
- Start date
- 1 Oct 2024
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Rongrong Liu
- Diseases
- Thalassaemia
- NCT number
- NCT06657391
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 396
- From 1 Oct 2024 to the primary completion date, 30 Sept 2027
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- patients with HLA-matched hematopoietic stem cell donors and willing to receive HLA-matched hematopoietic stem cell transplantation;
- patients having received thalidomide treatment within the past 3 months;
- patients having received any type of gene and/or cell therapy in the past;
Other illness
- 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 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;
- patients with severe allergies;
Lab values
- 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;
- peripheral blood white blood cell (WBC) count \<3×10\^9/L or platelet count \<100×10\^9/L;
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 3 years to 20 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hainan Provincial People's Hospital Coordinator of this site? Confirm its status | Haikou | China | Recruiting |
| Liuzhou Workers Hospital Coordinator of this site? Confirm its status | Liuzhou | China | Recruiting |
| Maoming people's hospital Coordinator of this site? Confirm its status | Maoming | China | Recruiting |
| The First Affiliated Hospital of Guangxi Medical University Coordinator of this site? Confirm its status | Nanning | China | Recruiting |
| Yulin Red Cross Hospital Coordinator of this site? Confirm its status | Yulin | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.