Clinical trial NCT06334367: Prophylaxis of Graft-versus-host Disease With Anti-CD25 Antibody in Patients Underwent HSCT
Official title: The Study of Anti-CD25 Antibody for Prophylaxis of GVHD in Patients Underwent Haploid Transplantation Conditioning With Low-dose ATG
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: GVHD
Lead sponsor: Shandong Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2024-03-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.).

Primary outcomes:
measure: The incidence of aGVHD
timeFrame: 100 days after HSCT
measure: The incidence of cGVHD
timeFrame: 1 year after HSCT
Secondary outcomes:
measure: the time of immune reconstitution in haploidentical transplant
timeFrame: 2 years after HSCT
measure: the time of infection occurrence
timeFrame: 2 years after HSCT
measure: the time of donor cell engraftment
timeFrame: 2 years after HSCT
measure: the time of disease relapse
timeFrame: 2 years after HSCT
measure: the time of death of transplant patient
timeFrame: 2 years after HSCT
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Hematology, Shandong Provincial Hospital Affiliated to Shandong First Medical University
state: Shandong
Study officials:
affiliation: Shandong Provincial Hospital
name: Xin Wang
role: STUDY_CHAIR
References: