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

GVHD Clinical Trial

Official title:

The Study of Anti-CD25 Antibody for Prophylaxis of GVHD in Patients Underwent Haploid Transplantation Conditioning With Low-dose ATG

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06334367
• Other study ID #: SWYX:NO.2022-1028
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 26, 2024
• Est. completion date: March 26, 2026

Study information

• Verified date: March 2024
• Source: Shandong Provincial Hospital
• Contact: Xiaosheng Fang
• Phone: 8615168889703
• Email: fxsh_1010[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 26, 2026
• Est. primary completion date: March 26, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.).

Related Conditions & MeSH terms

• GVHD

Intervention

Drug:
• CD25 treatment
CD25 prophylaxis
• low-dose ATG
HSCT pre-treatment with 7.5mg/Kg ATG(2.5mg/Kg/d) at day -4, -3 and -2.

Locations

Country	Name	City	State
China	Department of Hematology, Shandong Provincial Hospital Affiliated to Shandong First Medical University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Wang Xin

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of aGVHD	The time of aGVHD occurrence	100 days after HSCT
Primary	The incidence of cGVHD	The time of cGVHD occurrence	1 year after HSCT
Secondary	the time of immune reconstitution in haploidentical transplant	the time of immune reconstitution in haploidentical transplant	2 years after HSCT
Secondary	the time of infection occurrence	The incidence of infection	2 years after HSCT
Secondary	the time of donor cell engraftment	the effect of experimental protocol to engraftment	2 years after HSCT
Secondary	the time of disease relapse	the effect of experimental protocol to disease relapse	2 years after HSCT
Secondary	the time of death of transplant patient	the overall survival of patients	2 years after HSCT