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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

396 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2027-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Monitoring of Chimerism After Transplantation in Patients With β Thalassemia Major and the Treatment Strategies for the Reduction of Chimerism

NCT03101423

Beta Thalassemia Major

UNKNOWN NA

A Study to Evaluate the Safety and Efficacy of ET-01 Transplantation in Subjects with Transfusion Dependent Β-Thalassaemia.

NCT05752123

Transfusion Dependent Beta-Thalassaemia

TERMINATED NA

Safety and Efficacy of Gene Modified Autologous Hematopoietic Stem Cells to Treat Transfusion-dependent β-thalassemia

NCT05776173

β-thalassemia Major

RECRUITING NA

Anti-CD25 rhMAb for aGVHD Prevention in High-Risk Adults Using the daGOAT Model

NCT06880419

Acute Graft-versus-Host Disease

RECRUITING PHASE2

Prophylaxis of Graft-versus-host Disease With Anti-CD25 Antibody in Patients Underwent HSCT

NCT06334367

GVHD

NOT_YET_RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Transfusion Dependent Thalassemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

The researchers and the subjects wil aware of the grouping and the intervention they received. However, this trail will implement a blind method for the outcomes assessors, who objectively evaluated the outcome indicators without knowing the grouping of the subjects.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

intervention group

The intervention group will receive 4 doses of recombinant humanized anti-CD25 monoclonal antibody (Sunshine Guojian Pharmaceutical(Shanghai) Co.,Ltd.) on days +7, +14, +28, and +42 after transplantation, with a recommended dose of 1 mg/kg.

Group Type EXPERIMENTAL

recombinant humanized anti-CD25 monoclonal antibody

Intervention Type DRUG

The intervention group received 4 doses of recombinant humanized anti-CD25 monoclonal antibody on days +7, +14, +28, and +42 after transplantation, with a recommended dose of 1 mg/kg.

control group

The control group will receive no treatment at the same time points.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

recombinant humanized anti-CD25 monoclonal antibody

The intervention group received 4 doses of recombinant humanized anti-CD25 monoclonal antibody on days +7, +14, +28, and +42 after transplantation, with a recommended dose of 1 mg/kg.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

3 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No