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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06334367
Other study ID # SWYX:NO.2022-1028
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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.).

Study Design


Related Conditions & MeSH terms


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
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