GVHD
Conditions
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.
Interventions
DRUGCD25 treatment
CD25 prophylaxis
DRUGlow-dose ATG
HSCT pre-treatment with 7.5mg/Kg ATG(2.5mg/Kg/d) at day -4, -3 and -2.
Sponsors
Wang Xin
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| the time of donor cell engraftment | 2 years after HSCT | the effect of experimental protocol to engraftment |
| the time of immune reconstitution in haploidentical transplant | 2 years after HSCT | the time of immune reconstitution in haploidentical transplant |
| the time of death of transplant patient | 2 years after HSCT | the overall survival of patients |
| the time of disease relapse | 2 years after HSCT | the effect of experimental protocol to disease relapse |
| the time of infection occurrence | 2 years after HSCT | The incidence of infection |
Countries
China
Contacts
Primary ContactXiaosheng Fang
Outcome results
None listed