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Compares treatment options for Transfusion Dependent Thalassemia
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
ClinicalTrials.gov ID: NCT06657391
What this study is testing
What is recombinant humanized anti-CD25 monoclonal antibody?
recombinant humanized anti-CD25 monoclonal antibody is an investigational medicine, being studied as a potential treatment for transfusion dependent thalassemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 20
You may be able to join if
- patients with transfusion-dependent thalassemia;
- patients who are planning to receive matched unrelated donor hematopoietic stem cell transplantation (MUD-HSCT) or HLA haploidentical donor...
- physical condition score (Lansky/Karnofsky score) ≥ 70%;
- patients (or legal guardians) voluntarily participate in the study and sign the informed consent form
You likely can't join if
- 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...
See the full eligibility 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
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Maoming, Guangdong, China
- Liuzhou, Guangxi, China
- Nanning, Guangxi, China
- Yulin, Guangxi, China
- Haikou, Hainan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 20 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Maoming, Guangdong, China; Liuzhou, Guangxi, China; Nanning, Guangxi, China; Yulin, Guangxi, China; Haikou, Hainan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.