Prophylaxis of Graft-versus-host Disease With Anti-CD25 Antibody in Patients Underwent HSCT
- Conditions
- GVHD
- Interventions
- Drug: CD25 treatmentDrug: low-dose ATG
- Registration Number
- NCT06334367
- Lead Sponsor
- Wang Xin
- Brief Summary
The risk of Graft-versus-host Disease(GVHD) is significantly associated with the mortality rate of patients undergoing allogeneic hematopoietic stem cell transplantation. The occurrence of GVHD increases the hospitalization rate and economic burden of patients. In order to explore better methods for controlling GVHD, we designed a clinical trial using CD25 monoclonal antibody for GVHD prevention. Our previous studies have shown that reduced-dose anti-thymocyte globulin(ATG) in the conditioning regimen can achieve the same effect as full-dose ATG. Here, we try to explore the preventive effect of CD25 antibody on acute and chronic GHVD under low-dose ATG pretreatment condition.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40
- Patients with a clear diagnosis of hematologic disease, weighing ≥30kg, aged 18-60, of any gender and race;
- Willing to undergo haploidentical hematopoietic stem cell transplantation;
- Voluntarily participate in this study;
- Each subject must sign an informed consent form (ICF) indicating their understanding of the purpose and procedures of the study, and their willingness to participate. Considering the patient 's condition, if the patient' s signature is unfavorable for disease treatment, the informed consent form should be signed by the legal guardian or the patient 's immediate family member.
- Those with severe organ dysfunction or diseases, such as heart, liver, kidney, and pancreatic diseases;
- Patients who cannot tolerate CD25 monoclonal antibody treatment;
- Subjects and/or authorized family members who refuse allo-HSCT treatment;
- Any life-threatening diseases, physical conditions, or organ system dysfunctions that the researcher believes may jeopardize the safety of the subject and pose unnecessary risks to the study; drug dependence; uncontrolled mental illness in subjects; cognitive dysfunction;
- Those who have participated in other similar clinical studies within the past 3 months;
- Those deemed unsuitable for inclusion by the researcher (such as patients expected to be unable to adhere to treatment due to financial issues, etc.).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CD25 treatment CD25 treatment The humanized CD25 antibody was administered at 1 mg/kg iv on days+4 and +7 after HSCT. CD25 treatment low-dose ATG The humanized CD25 antibody was administered at 1 mg/kg iv on days+4 and +7 after HSCT. control group low-dose ATG -
- Primary Outcome Measures
Name Time Method The incidence of aGVHD 100 days after HSCT The time of aGVHD occurrence
The incidence of cGVHD 1 year after HSCT The time of cGVHD occurrence
- Secondary Outcome Measures
Name Time Method the time of donor cell engraftment 2 years after HSCT the effect of experimental protocol to engraftment
the time of disease relapse 2 years after HSCT the effect of experimental protocol to disease relapse
the time of death of transplant patient 2 years after HSCT the overall survival of patients
the time of immune reconstitution in haploidentical transplant 2 years after HSCT the time of immune reconstitution in haploidentical transplant
the time of infection occurrence 2 years after HSCT The incidence of infection
Trial Locations
- Locations (1)
Department of Hematology, Shandong Provincial Hospital Affiliated to Shandong First Medical University
🇨🇳Jinan, Shandong, China